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news – page 7 – eisai china lnc.-nba直播小9直播

first approval in japan for the lenvima plus keytruda combination

 

tokyo and kenilworth, n.j., december 24, 2021 – eisai (headquarters: tokyo, ceo: haruo naito) and merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada) today announced that the japanese ministry of health, labour and welfare (mhlw) has approved the combination of lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus keytruda, the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a., for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. this approval marks the first time the combination of lenvima plus keytruda has been approved in japan. lenvima plus keytruda is now approved in japan, the u.s. and europe for certain types of advanced endometrial carcinoma.

“rates of endometrial carcinoma have been steadily increasing in japan each year1, and there are limited options for patients who are diagnosed at an advanced stage or find their disease has returned,” said dr. gregory lubiniecki, vice president, clinical research, merck & co., inc., kenilworth, n.j., u.s.a. research laboratories. “with today’s approval, patients in japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy.”

“this is the first approval of the lenvima plus keytruda combination in japan,” said terushige iike, president of eisai japan, senior vice president, eisai. “we thank the patients, families and healthcare providers who made this approval possible. by delivering this combination therapy, we are proud to provide patients with advanced or recurrent endometrial carcinoma an additional treatment option.”

the approval is based on results from the pivotal phase 3 study 309/keynote-775 trial, in which lenvima plus keytruda demonstrated statistically significant improvements in overall survival (os), reducing the risk of death by 38% (hr=0.62 [95% ci, 0.51-0.75]; p<0.0001), and progression-free survival (pfs), reducing the risk of disease progression or death by 44% (hr=0.56 [95% ci, 0.47-0.66]; p<0.0001), versus chemotherapy (investigator’s choice of doxorubicin or paclitaxel). the median os was 18.3 months (95% ci, 15.2-20.5) for lenvima plus keytruda versus 11.4 months (95% ci, 10.5-12.9) for chemotherapy. the median pfs was 7.2 months (95% ci, 5.7-7.6) for lenvima plus keytruda versus 3.8 months (95% ci, 3.6-4.2) for chemotherapy.

the japanese package inserts for keytruda and lenvima note that in the study 309/keynote-775 trial, adverse reactions were observed in 395 patients (97.3%) out of the safety analysis set of 406 patients (including 51 out of 52 japanese patients) receiving lenvima  plus keytruda. the most common adverse reactions were hypertension in 249 patients (61.3%), hypothyroidism in 222 patients (54.7%), diarrhea in 171 patients (42.1%), nausea in 158 patients (38.9%), decreased appetite in 151 patients (37.2%), fatigue in 113 patients (27.8%), proteinuria in 105 patients (25.9%), vomiting in 98 patients (24.1%), weight decreased in 91 patients (22.4%), arthralgia in 87 patients (21.4%) and palmar-plantar erythrodysesthesia syndrome in 84 patients (20.7%).

endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and accounts for more than 90% of uterine cancers2. in japan, it is estimated there were more than 17,000 new cases of uterine cancer and more than 3,000 deaths in 2020 alone3. lenvima and keytruda have each received orphan drug designation in japan for endometrial carcinoma.

in addition to advanced endometrial carcinoma, eisai and merck & co., inc., kenilworth, n.j., u.s.a. continue to study the lenvima plus keytruda combination across several types of cancer with more than 20 clinical trials.

 

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about study 309/keynote-775 trial

the approval was based on data from study 309/keynote-775 (), a phase 3 multicenter, open-label, randomized, active-controlled study conducted in 827 patients (including 104 japanese patients) with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including in the neoadjuvant and adjuvant settings. the primary efficacy outcome measures were os, and pfs as assessed by blinded independent central review (bicr) according to recist v1.1.

patients were randomized 1:1 to receive lenvima (20 mg orally once daily) plus keytruda (200 mg intravenously every three weeks) or investigator’s choice, consisting of either doxorubicin (60 mg/m2 every three weeks) or paclitaxel (80 mg/m2 given weekly, three weeks on/one week off). treatment with lenvima plus keytruda continued until recist v1.1-defined progression of disease as verified by bicr, unacceptable toxicity, or for keytruda, a maximum of 24 months. administration of lenvima plus keytruda was permitted beyond recist-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated.

 

about lenvima® (lenvatinib) capsules

lenvima, discovered and developed by eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (vegf) receptors vegfr1 (flt1), vegfr2 (kdr), and vegfr3 (flt4). lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (fgf) receptors fgfr1-4, the platelet derived growth factor receptor alpha (pdgfrα), kit, and ret. in syngeneic mouse tumor models, lenvima decreased tumor-associated macrophages, increased activated cytotoxic t cells, and demonstrated greater antitumor activity in combination with an anti-pd-1 monoclonal antibody compared to either treatment alone.

currently, lenvima has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including japan, in europe, china and in asia, and in the united states for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. in addition, lenvima has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including japan, in europe, china and in asia, and in the united states for first-line unresectable hepatocellular carcinoma. lenvima has been approved for monotherapy as a treatment for unresectable thymic carcinoma in japan. it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in europe and asia, and in the united states the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. in europe, the agent was launched under the brand name kisplyx® for renal cell carcinoma. lenvima has been approved in combination with keytruda (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc) in united states and in europe. lenvima has been approved in combination with keytruda as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the united states, and has been approved for the similar indication (including conditional approval) in over 10 countries such as canada and australia. in some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.  in europe, it has been approved in combination with keytruda (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. in japan, it is approved in combination with keytruda (generic name: pembrolizumab) as the treatment of patients with unresectable advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy.

 

about keytruda® (pembrolizumab) injection, 100mg

keytruda is an anti-programmed death receptor-1 (pd-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. keytruda is a humanized monoclonal antibody that blocks the interaction between pd-1 and its ligands, pd-l1 and pd-l2, thereby activating t lymphocytes which may affect both tumor cells and healthy cells.

merck & co., inc., kenilworth, n.j., u.s.a. has the industry’s largest immuno-oncology clinical research program. there are currently more than 1,600 trials studying keytruda across a wide variety of cancers and treatment settings. the keytruda clinical program seeks to understand the role of keytruda across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with keytruda, including exploring several different biomarkers.

 

about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration

in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside the united states and canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as monotherapy and in combination with keytruda, the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a.

in addition to ongoing clinical studies evaluating the lenvima plus keytruda combination across several different tumor types, the companies have jointly initiated new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.

 

eisai’s focus on cancer

eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging rna splicing platform) as areas (ricchi) where real patient needs are still unmet, and where eisai can aim to become a frontrunner in oncology. eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these ricchi, with the aim of contributing to the cure of cancers.

 

about eisai

eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit (for global headquarters: eisai. co., ltd.), (for u.s. headquarters: eisai, inc.) or (for europe, middle east, africa, russia, australia and new zealand headquarters: eisai europe ltd.), and connect with us on twitter (. and ) and linkedin (for and ).

 

merck & co., inc., kenilworth, n.j., u.s.a.’s focus on cancer

our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. at merck & co., inc., kenilworth, n.j., u.s.a., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. as part of our focus on cancer, merck & co., inc., kenilworth, n.j., u.s.a. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. we also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. for more information about our oncology clinical trials, visit .

 

about merck & co., inc., kenilworth, n.j., u.s.a.  

for over 130 years, merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside of the united states and canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. we demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. today, merck & co., inc., kenilworth, n.j., u.s.a. continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as hiv and ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. for more information, visit and connect with us on , , , and .

 

forward-looking statement of merck & co., inc., kenilworth, n.j., usa

this news release of merck & co., inc., kenilworth, n.j., usa (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the u.s. private securities litigation reform act of 1995. these statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. there can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. if underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (covid-19); the impact of pharmaceutical industry regulation and health care legislation in the united states and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 annual report on form 10-k and the company’s other filings with the securities and exchange commission (sec) available at the sec’s internet site ().

 

1 yamagami w et al. clinical statistics of gynecologic cancers in japan. j gynecol oncol. 2017 mar;28(2):e32.

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2 american cancer society, “about endometrial cancer.”

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3 international agency for research on cancer, world health organization. “japan fact sheet.” cancer today, 2020.

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tokyo and cambridge, mass, dec. 24, 2021 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: michel vounatsos, “biogen”) announced today that lecanemab, an investigational anti-amyloid beta (aβ) protofibril antibody for the treatment of early alzheimer’s disease (ad), was granted fast track designation by the u.s. food and drug administration (fda). fda granted breakthrough therapy designation for lecanemab in june of 2021. breakthrough therapy designation and fast track designation are two fda programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as ad and provide opportunities for frequent interactions with the fda.

in september 2021, eisai initiated a rolling submission to the fda of a biologics license application (bla) for lecanemab under the accelerated approval pathway. the bla is primarily based on clinical, biomarker and safety data from the phase 2b clinical study (study 201) in people with early ad and confirmed amyloid pathology, and non-clinical and clinical parts of the application which consists of three parts (non-clinical, clinical and cmc) have already been submitted. the lecanemab phase 2b study results demonstrated a high degree of aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints. the correlation between the extent of aβ plaque reduction and effect on clinical endpoints in study 201 further supports aβ as a surrogate endpoint that is reasonably likely to predict clinical benefit.

the lecanemab clarity ad phase 3 clinical study in early ad is ongoing and completed enrollment in march 2021 with 1,795 patients. the fda has agreed that the results of clarity ad, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. blinded safety data from clarity ad is included to support the ongoing rolling submission. another phase 3 clinical study, ahead 3-45, is evaluating the efficacy of treatment with lecanemab in participants with preclinical ad and elevated amyloid and in participants with early preclinical ad and intermediate amyloid. additionally, eisai has initiated a lecanemab subcutaneous dosing phase 1 study.

alzheimer’s disease is a serious, progressive and devastating disease with few treatment options. eisai and biogen are committed to bring new treatment options to people living with early ad, their families and healthcare professionals who are waiting for them as early as possible.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) today announced it has entered into an agreement with gilead sciences, inc. (headquarters: foster city, california, “gilead”) for the commercialization and distribution of filgotinib (generic name, product name: jyseleca® ), an oral, jak1 preferential inhibitor for indications of rheumatoid arthritis (ra), ulcerative colitis, and crohn’s disease in asia (south korea, chinese taiwan, hksa and singapore). in december 2019, eisai signed a partnership agreement with gilead sciences k.k. (headquarters: tokyo), a japanese subsidiary of gilead, for the distribution and co-promotion of filgotinib in japan.

under the terms of the new agreement, eisai will obtain an exclusive marketing right for filgotinib in south korea, chinese taiwan, hksa and singapore from gilead. gilead has received approval for the treatment of ra in chinese taiwan and has applied for approval of filgotinib for the treatment of ra in south korea. following approvals, eisai will take over the manufacturing and marketing licenses for filgotinib from gilead in south korea and chinese taiwan. in hksa and singapore, eisai will apply for approval for filgotinib. with this agreement, eisai will pay gilead a contractual up-front payment, as well as regulatory milestones and sales milestones.

filgotinib is a once-daily, oral, jak1 preferential inhibitor. in japan, filgotinib has been approved for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. in april 2021, gilead sciences k.k. applied for an additional indication of filgotinib as a treatment for patients with moderate to severe active ulcerative colitis.

eisai will leverage its strong business foundation throughout asia, provide new treatment options for patients with rheumatoid arthritis and inflammatory bowel disease, and contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients their families, and healthcare providers.

developing solutions such as smartphones equipped with the brain health check tool “nouknow®”

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and fcnt limited (headquarters: kanagawa, ceo: katsumi takada, “fcnt”) announced today that both companies have entered into a business alliance agreement aiming to support people living with dementia and to prevent dementia, through developing solutions for maintaining brain performance. both companies will construct an ecosystem with the aim of supporting people living with and preventing dementia (“dementia ecosystem”), with integrating eisai’s wealth of experience and knowledge including drug creation and disease awareness activities as well as eisai’s solution measures such as digital technology, in the area of dementia, and fcnt’s products such as smartphones designed to offer outstanding usability for the elderly as well as fcnt’s services including “raku raku community” on sns targeting such smartphone users. with constructing a “dementia ecosystem”, both companies aim to contribute to the solution of dementia, which is one of the important social issues in an aging society.

the initiatives planned under the alliance are as follows.

1. the “nouknow®” will be installed on the “raku raku smartphone”

the “raku raku smartphone f-52b” developed and manufactured by fcnt will be equipped with the digital tool for self-assessment of brain performance (brain health) “nouknow” (pronounced “noh-noh”, non-medical equipment) distributed by eisai. it is scheduled to be released by ntt docomo, inc. (headquarters: tokyo, “ntt docomo”) in or after february 2022. this will be the first time that “nouknow” is deployed as a function that can be operated on a smartphone. f-52b users will be provided with brain performance checks at no cost by “nouknow” up to 4 times a year.

2. developing solutions for retaining good health and the disease prevention

eisai and fcnt will develop highly convenient solutions for the prevention of dementia, such as identifying future health concerns and predicting risks, with utilizing fcnt’s healthcare information infrastructure to accumulate data available among users, including step count, step speed and heart rate, as well as its management capacity to develop membership services such as “raku-raku community” (2.4 million members as of august 2021. based on available information by fcnt), an sns service for seniors with a membership system, in addition to eisai’s know-how based on various data in the area of dementia. furthermore, the both companies aim to deploy the new solutions developed based on this alliance for corporate customer, including businesses and regional governments, as a packaged solution that combines products and services owned by not only eisai and fcnt but also other industries and organizations.

eisai and fcnt will address and resolve the social issue related to dementia, and promote co-creation of value toward realizing a healthy and long-lived society through contributing to the construction of a “dementia ecosystem” by combining the strengths of the both companies.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the company will conduct a total of 42 poster presentations, including the latest data on its in-house discovered and developed anti-epileptic agent (aed) perampanel (product name: fycompa®) and in-house discovered and developed e2730, an investigational novel small compound for aed and the treatment for neurological diseases, at the 75th american epilepsy society annual meeting (aes2021), to be held in chicago, illinois and virtually from december 3 to 7, 2021.

major presentations regarding perampanel include poster presentations about the analysis results from the phase iii clinical trial (freedom/study 342), which evaluated long-term efficacy and safety of the perampanel monotherapy in the open-label extension (52 weeks) for epilepsy patients with focal-onset seizures (fos) from 12 to 74 years of age without prior treatment history (poster number: 1.283). additionally, an overview of phase iii and other clinical studies (poster number: 2.218) and a real-world pooled analysis of perampanel for elderly patients (poster number: 1.215), will be presented. for e2730, a poster presentation will be given on the non-clinical study results (poster number 2.197).

perampanel is a first-in-class aed discovered by eisai’s tsukuba research laboratories. the agent is a highly selective, noncompetitive ampa receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes. the agent is currently approved for partial onset seizures in over 70 countries including japan, the united states, china and other countries in europe and in asia. the agent is currently approved as an adjunctive therapy for primary generalized tonic-clonic seizures in over 70 countries including japan, the united states, and other countries in europe and in asia.

e2730 is a novel selective uncompetitive gat-1 (gaba transporter-1) inhibitor with a novel mechanism of action that selectively regulates activated synaptic functions, which was discovered by eisai’s tsukuba research laboratories. clinical study of e2730 for epilepsy is underway.

eisai considers neurology, including epilepsy, a therapeutic area of focus. eisai pursues its mission to provide “seizure freedom” to a greater number of patients with epilepsy. eisai remains committed further to addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.

 

■ main poster presentations

compound
poster number
planned date and time
(central standard time)
abstract title

perampanel
poster no: 1.215
poster presentation: december 4 (sat) poster discussion:12:00-14:00

the use of perampanel in elderly epilepsy patients:
pooled analysis of real-world studies

e2730
poster no: 2.197
poster presentation: december 5 (sun) poster discussion:12:00-14:00

discovery of e2730, a novel selective uncompetitive gat-1 inhibitor: in vivo characteristics

perampanel
poster no: 2.201
poster presentation: december 5 (sun) poster discussion:12:00-14:00

long-term perampanel monotherapy and health-related quality of life in patients with newly diagnosed/currently untreated recurrent focal-onset seizures (fos):
freedom study 342 extension phase

perampanel
poster no: 2.218
poster presentation: december 5 (sun) poster discussion:12:00-14:00

perampanel in elderly patients: an overview of data from studies 307, 335, 412, 342, and 506

perampanel
poster no: 3.219
poster presentation: december 6 (mon) poster discussion:12:00-13:45

perampanel for the treatment of pediatric patients in clinical practice by age category

perampanel
poster no: 1.283
virtual

long-term efficacy and safety of perampanel monotherapy in patients with newly diagnosed/currently untreated recurrent focal-onset seizures (fos):
freedom study 342 extension phase

perampanel
poster no: 2.202
virtual

long-term seizure freedom with adjunctive perampanel in patients with focal-onset and focal to bilateral tonic-clonic seizures: post hoc analysis of study 335 open-label extension (olex)

perampanel
poster no: 2.208
virtual

assessment of cognition (epitrack®) and depression (beck depression inventory-ii) following perampanel (monotherapy/first adjunctive) in patients with epilepsy enrolled in the elevate phase iv study

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

 

[notes to editors]

1. about perampanel (product name: fycompa)

perampanel is a first-in-class anti-epileptic agent (aed) discovered and developed by eisai. with epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes. perampanel is available in drug form to be taken once daily orally at bedtime. a tablet and fine granule formulation have been approved in japan. an oral suspension formulation and tablet have been approved in the united states and europe.

perampanel is currently approved in more than 70 countries and territories, including japan, the united states, china, and other countries in europe and in asia as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. in japan, the united states and china, perampanel is approved for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. in europe the approved age range has been expanded to 4 years and above.

in addition, perampanel has been approved in more than 70 countries, including the united states, japan, in europe and in asia for treatment as an adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. in europe the approved age range has been expanded to 7 years and above.

to date, perampanel has been used to treat more than 410,000 patients worldwide across all indications.

eisai is conducting a global phase iii clinical study (study 338) for the agent in patients with seizures associated with lennox-gastaut syndrome. in addition, eisai is conducting development of an injection formulation.

 

2. about e2730

e2730 is a novel selective uncompetitive gat-1 (gaba transporter-1) inhibitor with a novel mechanism of action that selectively regulates activated synaptic functions, which was discovered by eisai’s tsukuba research laboratories. clinical study for epilepsy is underway.

 

3. about epilepsy

epilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of epilepsy cases and generalized seizures accounting for approximately 40%. in a partial-onset seizure, an abnormal electrical disturbance occurs in a limited area of the brain, and may subsequently spread throughout the brain, becoming a generalized seizure (known as a secondarily generalized seizure). in a generalized seizure, abnormal electrical disturbances occur throughout the brain, and can be followed by a loss of consciousness or physical symptoms manifested throughout the whole body.

epilepsy affects approximately 3.4 million people in the united states, 1 million people in japan, 6 million people in europe, 9 million people in china, and approximately 60 million people worldwide. as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds,* this is a disease with significant unmet medical needs. although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly. as causes and clinical symptoms of pediatric epilepsy are not uniform, and prognoses can range from very positive cases to obstinate cases, special consideration for each patient is required of treatments.

*“the epilepsies and seizures: hope through research. what are the epilepsies?” national institute of neurological disorders and stroke, accessed may 24, 2016,

first combination of tyrosine kinase inhibitor with immunotherapy approved in europe for adult patients with advanced or recurrent endometrial carcinoma with disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation

approval based on study 309/keynote-775 results demonstrating statistically significant improvements in overall survival and progression-free survival compared with chemotherapy

 

tokyo and kenilworth, n.j., november 29, 2021 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada) today announced that the european commission has approved the combination of lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus keytruda, the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation. this marks the first combination of tyrosine kinase inhibitor with immunotherapy approved in europe for these patients with advanced or recurrent endometrial carcinoma.

the approval is based on results from the pivotal phase 3 study 309/keynote-775 trial, in which lenvima plus keytruda demonstrated statistically significant improvements in overall survival (os), reducing the risk of death by 38% (hr=0.62 [95% ci, 0.51-0.75]; p<0.0001), and progression-free survival (pfs), reducing the risk of disease progression or death by 44% (hr=0.56 [95% ci, 0.47-0.66]; p<0.0001), versus chemotherapy (investigator’s choice of doxorubicin or paclitaxel). the median os was 18.3 months for lenvima plus keytruda versus 11.4 months for chemotherapy. the median pfs was 7.2 months for lenvima plus keytruda versus 3.8 months for chemotherapy. the objective response rate (orr) was 32% (95% ci, 27-37) for patients treated with lenvima plus keytruda versus 15% (95% ci, 11-18) for patients treated with chemotherapy (p<0.0001). patients treated with lenvima plus keytruda achieved a complete response (cr) rate of 7% and partial response (pr) rate of 25% versus a cr rate of 3% and a pr rate of 12% for patients treated with chemotherapy.

“this approval is welcome news for patients in europe, and is based on the first phase 3 study evaluating an immunotherapy and tyrosine kinase inhibitor combination that showed superior overall survival for patients with advanced or recurrent endometrial cancer compared to chemotherapy,” said dr. gregory lubiniecki, vice president, clinical research, merck & co., inc., kenilworth, n.j., u.s.a. research laboratories. “regardless of mismatch repair status, patients whose endometrial cancer progresses or returns after prior platinum-containing systemic therapies now have a combination treatment option in keytruda plus lenvima that demonstrated a 38% reduction in risk of death compared to chemotherapy alone.”

“until recently, women in europe with advanced or recurrent endometrial cancer have faced a difficult prognosis and had few treatment options,” said corina dutcus, m.d., vice president, clinical research, oncology business group at eisai inc. “the approval of lenvima plus keytruda in this setting reflects the progress that we have made in our collaboration with merck & co., inc., kenilworth, n.j., u.s.a. in developing solutions for those diagnosed with difficult-to-treat cancers. we thank the patients, families and healthcare providers who made this milestone possible.”

in the study 309 trial, the most common adverse reactions of these patients (≥20%) for lenvima plus keytruda* were hypertension (63%), diarrhoea (57%), hypothyroidism (56%), nausea (51%), decreased appetite (47%), vomiting (39%), fatigue (38%), decreased weight (35%), arthralgia (33%), proteinuria (29%), constipation (27%), headache (27%), urinary tract infection (27%), dysphonia (25%), abdominal pain (23%), asthenia (23%), palmar-plantar erythrodysaesthesia syndrome (23%), stomatitis (23%), anaemia (22%), and hypomagnesaemia (20%).

this approval allows marketing of lenvima plus keytruda in all 27 eu member states plus iceland, liechtenstein, norway and northern ireland. lenvima plus keytruda is now approved by the european commission for two different types of cancer: for advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation and for the first-line treatment of adult patients with advanced renal cell carcinoma.

*according to the information listed in the smpc (summary of product characteristics)

 

about study 309/keynote-775 trial

the approval was based on data from study 309/keynote-775 (), a phase 3 multicenter, open-label, randomized, active-controlled study conducted in 827 patients with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including in the neoadjuvant and adjuvant settings. participants may have received up to two platinum-containing therapies in total, as long as one was given in the neoadjuvant or adjuvant treatment setting. the study excluded patients with endometrial sarcoma, carcinosarcoma, pre-existing grade ≥3 fistula, uncontrolled bp (>150/90 mmhg), significant cardiovascular impairment or event within previous 12 months or patients who had active autoimmune disease or a medical condition that required immunosuppression. the primary efficacy outcome measures were os, and pfs as assessed by blinded independent central review (bicr) according to recist v1.1. secondary efficacy outcome measures included orr as assessed by bicr.

patients were randomized 1:1 to receive lenvima (20 mg orally once daily) plus keytruda (200 mg intravenously every three weeks) or investigator’s choice, consisting of either doxorubicin (60 mg/m2 every three weeks) or paclitaxel (80 mg/m2 given weekly, three weeks on/one week off). treatment with lenvima plus keytruda continued until recist v1.1-defined progression of disease as verified by bicr, unacceptable toxicity, or for keytruda, a maximum of 24 months. administration of lenvima plus keytruda was permitted beyond recist-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated. a total of 121/411 (29%) of patients treated with lenvima plus keytruda received continued study therapy beyond recist-defined disease progression. the median duration of the post-progression therapy was 2.8 months. assessment of tumor status was performed every eight weeks.

 

about endometrial cancer1,2,3,4,5

endometrial cancer begins in the inner lining of the uterus, which is known as the endometrium and is the most common type of cancer in the uterus. worldwide, it was estimated there were more than 417,000 new cases and more than 97,000 deaths from uterine body cancers in 2020 (these estimates include both endometrial cancers and uterine sarcomas; more than 90% of uterine body cancers occur in the endometrium, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates). in japan, there were more than 17,000 new cases of uterine body cancer and more than 3,000 deaths from the disease in 2020. in europe., it is estimated there were more than 130,000 new cases of uterine body cancer and more than 29,000 deaths in 2020. the five-year relative survival rate for metastatic endometrial cancer (stage iv) is estimated to be approximately 17%.

 

about lenvima® (lenvatinib) capsules

lenvima, discovered and developed by eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (vegf) receptors vegfr1 (flt1), vegfr2 (kdr), and vegfr3 (flt4). lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (fgf) receptors fgfr1-4, the platelet derived growth factor receptor alpha (pdgfrα), kit, and ret. in syngeneic mouse tumor models, lenvima decreased tumor-associated macrophages, increased activated cytotoxic t cells, and demonstrated greater antitumor activity in combination with an anti-pd-1 monoclonal antibody compared to either treatment alone.

currently, lenvima has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including japan, in europe, china and in asia, and in the united states for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. in addition, lenvima has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including japan, in europe, china and in asia, and in the united states for first-line unresectable hepatocellular carcinoma. lenvima has been approved for monotherapy as a treatment for unresectable thymic carcinoma in japan. it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in europe and asia, and in the united states the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. in europe, the agent was launched under the brand name kisplyx® for renal cell carcinoma. lenvima has been approved in combination with keytruda (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc) in united states and in europe. lenvima has been approved in combination with keytruda as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the united states, and has been approved for the similar indication  (including conditional approval) in over 10 countries such as canada and australia. in some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.  in europe, it is approved in combination with keytruda (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation.

 

about keytruda® (pembrolizumab) injection, 100mg

keytruda is an anti-programmed death receptor-1 (pd-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. keytruda is a humanized monoclonal antibody that blocks the interaction between pd-1 and its ligands, pd-l1 and pd-l2, thereby activating t lymphocytes which may affect both tumor cells and healthy cells.

merck & co., inc., kenilworth, n.j., u.s.a. has the industry’s largest immuno-oncology clinical research program. there are currently more than 1,600 trials studying keytruda across a wide variety of cancers and treatment settings. the keytruda clinical program seeks to understand the role of keytruda across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with keytruda, including exploring several different biomarkers.

about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration

in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside the united states and canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as monotherapy and in combination with keytruda, the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a.

in addition to ongoing clinical studies evaluating the lenvima plus keytruda combination across several different tumor types, the companies have jointly initiated new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.

 

eisai’s focus on cancer

eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging rna splicing platform) as areas (ricchi) where real patient needs are still unmet, and where eisai can aim to become a frontrunner in oncology. eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these ricchi, with the aim of contributing to the cure of cancers.

 

about eisai

eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit (for global headquarters: eisai. co., ltd.), (for u.s. headquarters: eisai, inc.) or (for europe, middle east, africa, russia, australia and new zealand headquarters: eisai europe ltd.), and connect with us on twitter (. and ) and linkedin (for and ).

 

merck & co., inc., kenilworth, n.j., u.s.a.’s focus on cancer

our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. at merck & co., inc., kenilworth, n.j., u.s.a., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. as part of our focus on cancer, merck & co., inc., kenilworth, n.j., u.s.a. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. we also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. for more information about our oncology clinical trials, visit .

 

about merck & co., inc., kenilworth, n.j., u.s.a.  

for over 130 years, merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside of the united states and canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. we demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. today, merck & co., inc., kenilworth, n.j., u.s.a. continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as hiv and ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. for more information, visit and connect with us on , , , and .

 

forward-looking statement of merck & co., inc., kenilworth, n.j., usa

this news release of merck & co., inc., kenilworth, n.j., usa (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the u.s. private securities litigation reform act of 1995. these statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. there can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. if underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (covid-19); the impact of pharmaceutical industry regulation and health care legislation in the united states and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 annual report on form 10-k and the company’s other filings with the securities and exchange commission (sec) available at the sec’s internet site ().

 

1 american cancer society, “causes, risks, prevention.” endometrial cancer.

.

2 international agency for research on cancer, world health organization. “corpus uteri fact sheet.” cancer today, 2020.

.

3 international agency for research on cancer, world health organization. “japan fact sheet.” cancer today, 2020.

.

4 american cancer society, “about and key statistics.” endometrial cancer.

.

5 american cancer society, “detection, diagnosis, staging.” endometrial cancer.

.

approval based on results from clear/keynote-581 trial demonstrating lenvima plus keytruda significantly reduced the risk of disease progression or death by 61%, with a median progression-free survival of nearly two years versus nine months for sunitinib

 

tokyo and kenilworth, n.j., november. 29, 2021 – eisai (headquarters: tokyo, ceo: haruo naito) and merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada) today announced that the european commission has approved the combination of lenvima (kisplyx® in the european union [eu] for the treatment of advanced renal cell carcinoma [rcc]), the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus,  keytruda, the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a., for the first-line treatment of adult patients with advanced rcc.

the approval for advanced rcc is based on results from the pivotal phase 3 clear (study 307)/keynote-581 trial, in which lenvima plus keytruda demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (pfs), reducing the risk of disease progression or death by 61% (hr=0.39 [95% ci, 0.32-0.49]; p<0.0001) with a median pfs of 23.9 months versus 9.2 months for sunitinib, and overall survival (os), reducing the risk of death by 34% (hr=0.66 [95% ci, 0.49-0.88]; p=0.0049) versus sunitinib. median os was not reached at the time of analysis in either study arm. the objective response rate (orr) was 71% (95% ci: 66-76) for patients treated with lenvima plus keytruda (n=355) versus 36% (95% ci: 31-41) for patients treated with sunitinib (n=357; p<0.0001). patients treated with lenvima plus keytruda achieved a complete response (cr) rate of 16% and partial response (pr) rate of 55% versus a cr rate of 4% and a pr rate of 32% for patients treated with sunitinib.

“a key focus of our collaboration with eisai is to advance our clinical development program to evaluate the potential of keytruda plus lenvima to improve responses across different types of cancer, including renal cell carcinoma,” said dr. gregory lubiniecki, vice president, clinical research, merck & co., inc., kenilworth, n.j., u.s.a. research laboratories. “today’s approval of keytruda plus lenvima brings a new treatment option to patients with advanced renal cell carcinoma in europe, and further validates our efforts to research this promising combination of an immunotherapy and tyrosine kinase inhibitor for some of the most difficult-to-treat cancers.”

“renal cell carcinoma is the most common type of kidney cancer in both men and women, marking the significance of the european approval for the lenvima plus keytruda combination,” said corina dutcus, m.d., vice president, clinical research, oncology business group at eisai inc. “we remain committed to continuing to explore this combination therapy with the goal of improving care for people living with cancer. the participation of many patients, families and healthcare providers made this approval possible, for which we are very grateful.”

in the clear/keynote-581 trial, the most common adverse reactions (≥30%) for lenvima plus keytruda* were diarrhoea (61.8%), hypertension (51.5%) fatigue (47.1%), hypothyroidism (45.1%), decreased appetite (42.1%), nausea (39.6%), stomatitis (36.6%), proteinuria (33.0%), dysphonia (32.8%), and arthralgia (32.4%).

this approval allows marketing of lenvima plus keytruda in all 27 eu member states plus iceland, liechtenstein, norway and northern ireland. lenvima plus keytruda is now approved by the european commission for two different types of cancer: for the first-line treatment of adult patients with advanced renal cell carcinoma and for advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.

*according to the information listed in the smpc (summary of product characteristics)

 

about clear/keynote-581 trial

the approval was based on data from the clear(study 307)/keynote-581 trial (), a phase 3, multicenter, open-label, randomized trial conducted in 1,069 patients with advanced rcc with clear cell component including other histological features such as sarcomatoid and papillary in the first-line setting.

patients were enrolled regardless of pd-l1 tumor expression status. the study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. randomization was stratified by geographic region (north america and western europe vs. “rest of the world”) and memorial sloan kettering cancer center (mskcc) prognostic groups (favorable vs. intermediate vs. poor). the primary efficacy outcome measure was pfs based on blinded independent central review (bicr) using recist 1.1, and pfs results were consistent across pre-specified subgroups, mskcc prognostic groups and pd-l1 tumor expression status. key secondary efficacy outcome measures were os and orr.

patients were randomized 1:1:1 to receive lenvima (20 mg orally once daily) plus keytruda (200 mg intravenously every three weeks for up to 24 months), or lenvima (18 mg orally once daily) plus everolimus (5 mg orally once daily), or sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment). treatment continued until unacceptable toxicity or disease progression as determined by investigator and confirmed by bicr using recist 1.1. administration of lenvima plus keytruda was permitted beyond recist-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. keytruda was continued for a maximum of 24 months; however, treatment with lenvima could be continued beyond 24 months. assessment of tumor status was performed at baseline and then every eight weeks.

 

about renal cell carcinoma (rcc)1,2,3,4,5,6

worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. in japan, there were more than 25,000 new cases and 8,000 deaths in 2020. in europe, it is estimated there were more than 138,000 new cases of kidney cancer diagnosed and more than 54,000 deaths from the disease in 2020.  renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are rcc. renal cell carcinoma is about twice as common in men as in women. most cases of rcc are discovered incidentally during imaging tests for other abdominal diseases. approximately 30% of patients with rcc will have metastatic disease at diagnosis. survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 13% for patients diagnosed with metastatic disease.

 

about lenvima® (lenvatinib); available as 10mg and 4mg capsules

lenvima, discovered and developed by eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (vegf) receptors vegfr1 (flt1), vegfr2 (kdr), and vegfr3 (flt4). lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (fgf) receptors fgfr1-4, the platelet derived growth factor receptor alpha (pdgfrα), kit, and ret. in syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic t cells, and demonstrated greater antitumor activity in combination with an anti-pd-1 monoclonal antibody compared to either treatment alone.

currently, lenvima has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including japan, in europe, china and in asia, and in the united states for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. in addition, lenvima has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including japan, in europe, china and in asia, and in the united states for first-line unresectable hepatocellular carcinoma. lenvima has been approved for monotherapy as a treatment for unresectable thymic carcinoma in japan. it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in europe and asia, and in the united states the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. in europe, the agent was launched under the brand name kisplyx® for renal cell carcinoma. lenvima has been approved in combination with keytruda (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc) in united states and in europe. lenvima has been approved in combination with keytruda (generic name: pembrolizumab) as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the united states, and has been approved for the similar indication  (including conditional approval) in over 10 countries such as canada and australia. in some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. in europe, it is approved in combination with keytruda (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation.

 

about keytruda® (pembrolizumab) injection, 100mg

keytruda is an anti-programmed death receptor-1 (pd-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. keytruda is a humanized monoclonal antibody that blocks the interaction between pd-1 and its ligands, pd-l1 and pd-l2, thereby activating t lymphocytes which may affect both tumor cells and healthy cells.

merck & co., inc., kenilworth, n.j., u.s.a. has the industry’s largest immuno-oncology clinical research program. there are currently more than 1,600 trials studying keytruda across a wide variety of cancers and treatment settings. the keytruda clinical program seeks to understand the role of keytruda across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with keytruda, including exploring several different biomarkers.

about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration

in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside the united states and canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as monotherapy and in combination with keytruda, the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a.

in addition to ongoing clinical studies evaluating the lenvima plus keytruda combination across several different tumor types, the companies have jointly initiated new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.

 

eisai’s focus on cancer

eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging rna splicing platform) as areas (ricchi) where real patient needs are still unmet, and where eisai can aim to become a frontrunner in oncology. eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these ricchi, with the aim of contributing to the cure of cancers.

 

about eisai

eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit (for global headquarters: eisai. co., ltd.), (for u.s. headquarters: eisai, inc.) or (for europe, middle east, africa, russia, australia and new zealand headquarters: eisai europe ltd.), and connect with us on twitter (. and ) and linkedin (for and ).

 

merck & co., inc., kenilworth, n.j., u.s.a.’s focus on cancer

our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. at merck & co., inc., kenilworth, n.j., u.s.a., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. as part of our focus on cancer, merck & co., inc., kenilworth, n.j., u.s.a. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. we also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. for more information about our oncology clinical trials, visit .

 

about merck & co., inc., kenilworth, n.j., u.s.a.  

for over 130 years, merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside of the united states and canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. we demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. today, merck & co., inc., kenilworth, n.j., u.s.a. continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as hiv and ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. for more information, visit and connect with us on , , , and .

 

forward-looking statement of merck & co., inc., kenilworth, n.j., usa

this news release of merck & co., inc., kenilworth, n.j., usa (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the u.s. private securities litigation reform act of 1995. these statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. there can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. if underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (covid-19); the impact of pharmaceutical industry regulation and health care legislation in the united states and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 annual report on form 10-k and the company’s other filings with the securities and exchange commission (sec) available at the sec’s internet site ().

 

1  international agency for research on cancer, world health organization. “kidney fact sheet.” cancer today, 2020.

.

2  international agency for research on cancer, world health organization. “japan fact sheet.” cancer today, 2020.
.

3  american cancer society. key statistics about kidney cancer.
.

4  seattle cancer care alliance. “kidney cancer fact.”

.

5  richard e. et al. renal cell carcinoma: diagnosis and management. american family physician. 2019 feb 1;99(3):179-184.

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6  cancer. net. “statistics, 2021.” kidney cancer.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been selected for a membership in the dow jones sustainability asia pacific index (djsi asia pacific), the asia pacific version of the dow jones sustainability indices (djsi), which are a family of premier global indices for socially responsible investment (sri). this marks eisai’s eighth selection.

the djsi family was jointly established between robecosam ag (switzerland) and s&p dow jones indices llc (united states) in 1999 and assesses the corporate sustainability performance of eligible member companies based on economic, environmental and social criteria. the djsi is one of the important investment criteria for the investors around the world who emphasize on corporate initiatives for improving non-financial value focused on environmental, social, and governance (esg).this year, the djsi asia pacific has selected top 153 companies (77 of which are from japan) from among the approximate major 600 companies in the region. eisai received high scores in categories such as environmental reporting, efforts for human rights, product quality & recall management, as well as addressing cost burden regarding affordability and contribution to control of medical expenses.

in addition to the djsi asia pacific, eisai has been selected for the ftse4good index series, which is another global benchmark sri index as well as for the msci japan empowering women index (win), the ftse blossom japan index, the msci japan esg select leaders index and s&p/jpx carbon efficient index, which are the four esg investment indices for japanese stocks adopted by the government pension investment fund (gpif).

eisai’s corporate philosophy is to give first thought to patients and their families, and increase the benefits that health care provides as well as address diverse healthcare needs worldwide. by strengthening its esg initiatives and increasing non-financial value, eisai is striving to sustainably enhance corporate value based on this corporate philosophy.

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it has been selected as the winner of the “most liked!” ir award at the 2021 ir award, hosted by the japan investor relations association (chairman: naoki izumiya, “jira”).

the “most liked!” ir award has been newly created for commemorating the 25th anniversary of the best ir award in 2020. the award is designed to reflect the viewpoints of companies that applied for the ir award based on their voting, share their proactive ir experiences, and realize best practices. the theme for 2021 is “ir activities contributing sustainability,” awarding companies that have actively promoted information disclosure and their dialogue with investors on sustainability-related matters. of the companies that applied for the 2021 ir award, 178 companies entered the “most liked!” ir award and the top 17 companies, including eisai, were selected based on a mutual vote by the candidate companies.

for further details, please visit the jira website:

eisai has focused on disseminating information regarding financial capital and non-financial capital value relevance that link to corporate value for longer-term as well as continuously through publicizing the results of the analysis of the correlation between esg-related indicators and pbr (price book-value ratio) , holding discussion meetings with investors, or publishing the eisai value creation report. the award was given to eisai with “empathy” for eisai’s efforts to visualize esg.

eisai’s corporate philosophy is to give first thought to patients and their families, and increase the benefits that health care provides as well as address diverse healthcare needs worldwide. together with strengthening its esg initiatives in order to realize this corporate philosophy, eisai respects the rights of shareholders and investors, ensures fairness and transparency in management, and works on its ir activities to aid the enhancement of corporate value.

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

consistency of efficacy assessments evaluated across various statistical methods

 

tokyo and cambridge, mass., nov.12, 2021 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: michel vounatsos, “biogen”) announced today results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad). this presentation was made by eisai at the 2021 clinical trials on alzheimer’s disease (ctad) conference, november 9-12, 2021 in boston, massachusetts and virtually.

in september 2021, eisai initiated a rolling submission of a biologics license application (bla) for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early ad, to the u.s. food and drug administration (fda) under the accelerated approval pathway.

study 201, a multicenter, double-blind, placebo-controlled, phase 2b trial conducted in 856 patients with early ad, evaluated key efficacy assessments, including clinical change on the alzheimer’s disease composite score (adcoms) at the primary endpoint of 12 months and at select key secondary endpoints, clinical dementia rating-sum-of-boxes (cdr-sb) and alzheimer’s disease assessment scale-cognitive subscale (adas-cog14) at 18 months. six sensitivity analyses across four statistical models (mixed model for repeated measures, disease progression model, natural cubic spline model, and quadratic mixed model) showed consistent positive lecanemab treatment effects for adcoms, cdr-sb and adas-cog14 at 18 months.

the primary endpoint was bayesian analysis of 12-month clinical change on adcoms with the goal to identify the most efficacious dose (ed90 dose). primary analysis was super-superiority over placebo by ≥25%: goal was 80% probability of ≥25% reduction in decline versus placebo. study achieved the goal of identifying smallest dose that achieved ≥90% of maximum treatment effect (10 mg/kg biweekly), i.e., the ed90 dose. at 12 months, ed90 dose had 64% probability of being super-superior to placebo by 25% reduction. at 12 months, ed90 dose had 98% probability superior to placebo. consistent treatment effect was observed at 18 months for adcoms (29% to 37%), cdr-sb (26.5% to 35%), and adas-cog (47% to 56%), with separation from placebo observed by six months for the top dose (10mg/kg biweekly) across all analyses.

“in study 201, lecanemab showed robust clearance of brain amyloid and slowing of clinical decline across several clinical and biomarker endpoints. this sensitivity analysis shows lecanemab clinical efficacy results across statistical models are consistent, reliable and further enhances our confidence in the clinical potential of this investigational therapy,” said michael irizarry, m.d., vice president, deputy chief clinical officer, neurology business group, eisai inc. “through our comprehensive research program, we will continue to advance the understanding of how this anti-amyloid beta protofibril antibody may play a role in the treatment of early and preclinical ad. in march 2021, eisai completed enrollment of 1,795 patients with early alzheimer’s disease in our confirmatory phase 3 clarity ad clinical study. the phase 3 clinical study, ahead 3-45, is currently exploring lecanemab’s safety and efficacy in individuals with preclinical ad.”

this release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.

 

[notes to editors]

1. about lecanemab (ban2401)

lecanemab is an investigational humanized monoclonal antibody for alzheimer’s disease (ad) that is the result of a strategic research alliance between eisai and bioarctic. lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in ad. as such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. with regard to the results from pre-specified analysis at 18 months of treatment, study 201 demonstrated reduction of brain aβ accumulation (p<0.0001) and slowing of disease progression measured by adcoms* (p<0.05) in early ad subjects. the study did not achieve its primary outcome measure** at 12 months of treatment. the study 201 open-label extension was initiated after completion of the core period and a gap period off treatment (average of 24 months) to evaluate safety and efficacy, and is underway.

eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of ad pursuant to an agreement concluded with bioarctic in december 2007. in march

2014, eisai and biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in october 2017. currently, lecanemab is being studied in a pivotal phase 3 clinical study in symptomatic early ad (clarity-ad), following the outcome of the phase 2 clinical study (study 201). in july 2020 the phase 3 clinical study (ahead 3-45) for individuals with preclinical ad, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, was initiated. ahead 3-45 is conducted as a public-private partnership between the alzheimer’s clinical trial consortium that provides the infrastructure for academic clinical trials in alzheimer’s disease and related dementias in the u.s., funded by the national institute on aging, part of the national institutes of health, eisai and biogen.

* developed by eisai, adcoms (ad composite score) combines items from the adas-cog (alzheimer’s disease assessment scale-cognitive subscale), cdr (clinical dementia rating) and the mmse (mini-mental state examination) scales to enable a sensitive detection of changes in clinical functions of early ad symptoms and changes in memory.

** an 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by adcoms from baseline compared to placebo.

 

2. about the collaboration between eisai and biogen for alzheimer’s disease

eisai and biogen are collaborating on the joint development and commercialization of ad treatments. eisai serves as the lead in the co-development of lecanemab.

 

3. about the collaboration between eisai and bioarctic for alzheimer’s disease

since 2005, bioarctic has had a long-term collaboration with eisai regarding the development and commercialization of drugs for the treatment of ad. the commercialization agreement on the lecanemab antibody was signed in december 2007, and the development and commercialization agreement on the antibody lecanemab back-up for ad, which was signed in may 2015. eisai is responsible for the clinical development, application for market approval and commercialization of the products for ad. bioarctic has no development costs for lecanemab in ad.

 

4. about eisai co., ltd.

eisai co., ltd. is a leading global pharmaceutical company headquartered in japan. eisai’s corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. with a global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of neurology and oncology.

leveraging the experience gained from the development and marketing of a treatment for alzheimer’s disease, eisai aims to establish the “eisai dementia platform.” through this platform, eisai plans to deliver novel benefits to those living with dementia and their families through constructing a “dementia ecosystem,” by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. for more information about eisai co., ltd., please visit .

 

5. about eisai inc.

at eisai inc., human health care (hhc) is our goal. we give our first thoughts to patients and their families, and helping to increase the benefits health care provides. as the u.s. pharmaceutical subsidiary of tokyo-based eisai co., ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs. eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). our u.s. headquarters, commercial and clinical development organizations are located in new jersey; our discovery labs are in massachusetts and pennsylvania; and our global demand chain organization resides in maryland and north carolina. to learn more about eisai inc., please visit us at  and follow us on twitter and linkedin.

 

6. about biogen

as pioneers in neuroscience, biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. one of the world’s first global biotechnology companies, biogen was founded in 1978 by charles weissmann, heinz schaller, sir kenneth murray, and nobel prize winners walter gilbert and phillip sharp. today, biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of alzheimer’s disease. biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

in 2020, biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. healthy climate, healthy lives™ aims to eliminate fossil fuels across the company’s operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.

the company routinely posts information that may be important to investors on its website at www.biogen.com. to learn more, please visit www.biogen.com and follow biogen on social media – , , , .

 

7. biogen safe harbor

this news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the private securities litigation reform act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab and aduhelm; potential regulatory discussions, submissions and approvals and the timing thereof; the expected data readout for the clarity ad study; the treatment of alzheimer’s disease; the anticipated benefits and potential of biogen’s collaboration arrangements with eisai; the potential of biogen’s commercial business and pipeline programs, including lecanemab and aduhelm; and risks and uncertainties associated with drug development and commercialization. these statements may be identified by words such as “aim,” “anticipate,”

“believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. you should not place undue reliance on these statements or the scientific data presented.

these statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of biogen’s drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing covid-19 pandemic on biogen’s business, results of operations and financial condition. the foregoing sets forth many, but not all, of the factors that could cause actual results to differ from biogen’s expectations in any forward-looking statement. investors should consider this cautionary statement as well as the risk factors identified in biogen’s most recent annual or quarterly report and in other reports biogen has filed with the u.s. securities and exchange commission. these statements are based on biogen’s current beliefs and expectations and speak only as of the date of this news release. biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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