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the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with alzheimer’s disease

the centers for medicare & medicaid services (cms) announced broader medicare coverage of leqembi

 

tokyo and cambridge, mass., july 6, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that the u.s. food and drug administration (fda) has approved the supplemental biologics license application (sbla) supporting the traditional approval of leqembi® (lecanemab-irmb) 100 mg/ml injection for intravenous use, making leqembi the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with alzheimer’s disease (ad). leqembi demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to u.s. medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications and patients with mild cognitive impairment (mci) due to ad or mild ad. treatment with leqembi should be initiated in patients with mci or mild dementia stage of disease, (collectively referred to as early ad) the population in which treatment was initiated in clinical trials.

leqembi’s traditional approval is based on phase 3 data from eisai’s large, global clarity ad clinical trial, in which leqembi met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of leqembi. the primary endpoint was the global cognitive and functional scale, clinical dementia rating sum of boxes (cdr-sb). leqembi treatment reduced clinical decline on cdr-sb by 27% at 18 months compared to placebo. additionally, the secondary endpoint of ad cooperative study-activities of daily living scale for mild cognitive impairment (adcs mci-adl), as measured by people caring for patients with ad, noted a statistically significant benefit of 37%. this measures the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. full results of the clarity ad study were presented at the clinical trials on alzheimer’s disease (ctad) 2022 conference and simultaneously published in the peer-reviewed medical journal the new england journal of medicine on november 29, 2022.

importantly, following fda’s traditional approval of leqembi, cms confirmed that broader coverage of leqembi is now available and released more details on the registry, including the easy-to-use data submission process. the cms-facilitated registry is now available for healthcare professionals to submit required patient data to cms. eisai is pleased that medicare will cover this important therapy for appropriate patients. this will facilitate reimbursement for and access to leqembi across a broad range of healthcare settings in the united states.

“today, the fda approved leqembi under the traditional approval pathway, making leqembi the first and only approved anti-amyloid alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease. as a research and development-focused company based on our hhc (human health care) concept, we are proud that the results of eisai’s ad research over the past 40 years have been recognized and delivered to people living with this disease in the united states,” said haruo naito, chief executive officer at eisai. “alzheimer’s disease is a progressive, fatal disease that greatly impacts not only the people living with it, but also their loved ones, care partners and society. we continue to work to create broad and simple access to leqembi for patients and to support diagnosis and treatment at the early stage of the disease. eisai will diligently work to educate physicians on the safe and appropriate use of leqembi to maximize its benefit to people living with early ad and their families.”

“today marks a breakthrough in the treatment of alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable. we would like to express our sincere appreciation to those who have worked tirelessly to find a treatment for this unrelenting disease, without whom this progress would not be possible,” said christopher a. viehbacher, president and chief executive officer of biogen. “our focus is now on the path forward, working alongside eisai with the goal of making leqembi accessible to eligible patients as soon as possible.”

leqembi is a humanized immunoglobulin gamma 1 (igg1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of amyloid beta (aβ). critically, leqembi targets and clears the most neurotoxic form of aβ that continuously accumulates as well as removes the existing plaques to treat this progressive, chronic disease. in june 2023, the fda’s peripheral and central nervous system drugs (pcns) advisory committee voted unanimously that the data from eisai’s clarity ad clinical trial confirmed the clinical benefit of leqembi for the treatment of ad. committee members also confirmed the overall risk-benefit of leqembi. on january 6, 2023, leqembi was approved by the fda under the accelerated approval pathway.

eisai has developed and deployed understanding aria™, a multi-faceted educational initiative to further advance understanding in the ad healthcare community of the real-world management and monitoring of amyloid-related imaging abnormalities (aria). in collaboration with experts in the field of medical imaging as well as major professional societies, understanding aria™ offers resources and programs that include peer-to-peer education, individual and group educational sessions and subject matter-expert evaluation of historical case studies.

eisai is committed to ensuring that appropriate patients have access to leqembi and has established a patient assistance program to provide leqembi at no cost, for eligible uninsured and underinsured patients, including medicare beneficiaries, who meet financial need and other program criteria. additionally, eisai offers patient support for improving access through leqembi patient navigators, who will provide information about accessing leqembi, help patients and their families understand their insurance coverage and options, and identify financial support programs for eligible patients. people in the u.s. can learn more about these services by visiting leqembi.com, calling 1-833-4- leqembi (1-833-453-7362), monday-friday, 8 a.m. to 8 p.m. eastern time or faxing an enrollment form to 1-833-770-7017.

eisai serves as the lead of leqembi development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

 

media contacts:
eisai co., ltd.
public relations department
tel: 81 (0)3-3817-5120

biogen inc.
jack cox
1 781-464-3260
public.affairs@biogen.com

eisai inc. (u.s.)
libby holman
1-201-753-1945
libby_holman@eisai.com

eisai europe, ltd.
(uk, europe, australia, new zealand and russia)
emea communications department
44 (0) 786 601 1272
emea-comms@eisai.net

investor contacts:
eisai co., ltd.
investor relations department
tel: 81 (0) 3-3817-5122

biogen inc.
chuck triano
1-781-464-2442
ir@biogen.com

  • new research collaboration brings together world-leading institutions’ collective expertise in therapeutics, technology, health data, technology commercialisation and advanced analytics/data science in neurology.
  • two-year pilot provides a launch pad for translating scientific prototypes into practical solutions that demonstrate real-world impact.
  • neurii collaboration builds on eisai’s extensive experience in delivering innovative treatments in neurology and supports ongoing contributions to the global digital health ecosystem.

tokyo, hatfield, seattle, london, and edinburgh, 29 june, 2023 – eisai, gates ventures, health data research uk (hdr uk), lifearc and the university of edinburgh announced today a new two-year collaborative research agreement. the collaboration, named neurii is a unique pioneering partnership that creates a powerhouse collaboration of collective expertise in therapeutics, technology development and commercialization, health data management and advanced analytics/data science to predict, protect and promote brain health.

neurii will focus its initial efforts to develop data and digital solutions to complement approved treatment options for patients and solve issues related to the prediction, prevention, management, and treatment of dementia related disorders.

this groundbreaking collaboration will use high-quality individual data, artificial intelligence (ai), and machine learning (ml) to deliver patient-focused digital health solutions by developing initial pilot projects originated in highly recognized uk academic centres. these projects have been selected on the basis of their potential to make a meaningful difference to patients’ lives while maintaining data security and public trust. by combining diverse digital biomarkers that can be acquired non-invasively in real world clinical and non-clinical settings (e.g., speech from conversation) with the high-quality and abundant medical data accumulated in the uk, and analyzing them with tailored ai algorithms, neurii will create innovative digital solutions. these will be deployed in the detection, monitoring and treatment of dementia patients in order to improve their lives as well as minimizing the impact of the disease burden on their carers and families.

this initial two-year pilot establishes a first-in-class launch pad underpinned by an innovative business model and scalable prototype for translating scientific prototypes that will enhance and improve public health demonstrating real world impact. it is envisaged that neurii partners will explore further opportunities to scale up the program developing digital health solutions worldwide.

dr. teiji kimura, ph.d., academia and industry alliance officer, deep human biology learning (dhbl) office of eisai, commented, “dementia is one of the major social and medical issues in an aging society, and eisai’s mission is to contribute to solving these issues. we aim to create new digital solutions that will contribute to solving the challenges of dementia by combining the uk’s leadership in this field with our experience and track record of continuously creating innovative treatments in the field of dementia whilst staying true to our human health care concept of giving first thought to patients and the people in the daily living domain.”

it is estimated that more than 55 million are currently living with dementia in the world, and nearly one million people in the uk, and this number is expected to grow rapidly.1,2 as well as having a significant impact on the lives of patients and those who care for them (52% of the uk public knows someone who has been diagnosed with a form of dementia), these conditions place significant pressure on health and social care systems. providing data-driven solutions that complement existing treatments could help to improve earlier detection and diagnosis, evidence-based treatment decision-making, monitoring of disease progression and maintenance of quality of life.

“ai and other advanced technologies are beginning to play a powerful role in medical research,” said dr. niranjan bose, managing director of health & life sciences at gates ventures. “i’m excited about how the neurii collaboration will apply these tools to diagnostics research and drug discovery, and contribute to breakthroughs that can improve life for millions of people suffering with dementia and dementia-related illnesses.”

“identifying ways to prevent dementia and neurodegenerative disease is a key part of our multi-million-pound neurodegeneration program’ said paul wright, mnd translational challenge lead at lifearc “‘this collaboration is one of many new innovative projects we are involved in to improve the diagnosis of dementia and a positive step towards predicting those who may develop the disease.”

the uk is a leader in digital technology investment and research across areas such as genomics, health data science, ai and ml, with rich and diverse health-related data. neurii’s model will enable the identification of pioneering data and digital science, the mentoring of talented scientists and the translation of health prototypes into practical and accessible products. by bringing together the expertise and capabilities of the neurii collaborators, it is hoped that the novel approach will provide an exciting launch-pad for new transformational digital products that can contribute to solving the ongoing challenges of dementia and neurodegenerative conditions.

professor andrew morris, director of hdr uk, said: “almost one million people in the uk are living with dementia. this new public-private partnership aims to gain a deeper understanding of the disease through trustworthy use of large datasets of anonymised health data in secure environments. we will take forward a set of pilot projects and engage with the public. our aim is to produce new data-driven products that will benefit patients and their families in detecting dementia, predicting its progress and better managing the disease.”

neurii academic lead professor siddharthan chandran, of the university of edinburgh, said: “the university of edinburgh is delighted to be part of this ambitious cross-sector digital partnership that has, as an explicit goal, the creation of low cost and globally scalable digital tools to predict and monitor dementia.”

outputs from the neurii collaboration will be shared quarterly internally and released externally when appropriate.

 

1  world health organization. fact sheets, dementia

2 alzheimer’s research uk. dementia statistics hub. number of people in the uk. 2022. available at:

 

media contacts:

eisai co., ltd.
public relations department
81-(0)3-3817-5120

eisai europe, ltd.
bily kuo
director, communications emea
emea-comms@eisai.net
44 (0) 7739 600 678

for queries relating to any of the signing partners: uoe, gates ventures, lifearc and hdruk
university of edinburgh/edinburgh innovations
megan welford
communications manager
megan.welford@ei.ed.ac.uk
44 07721 120217

on june 26th, tencent healthcare and eisai china signed a strategic cooperation agreement. the two parties will use tencent healthcare’s pharmaceutical industry saas solution – nges (next generation engagement suite), a one-stop management platform for physician interaction as a base, by deeply integrating tencent’s connectivity advantages and digital technology with eisai china’s core scenarios of customer management, multi-channel marketing and conference event management, eisai china will realize a new paradigm of online and offline integration of academic communication, in order to help eisai china open up the whole domain scenarios, link up “application islands”, continue to cultivate the chinese market with management upgrade and model innovation, and achieve high-quality development.

yanhui feng, senior vice president of eisai global and president of eisai china, alexander ng, vice president and head of tencent healthcare, yang zhou, general manager of nta bu of eisai china, and yu zhang, vice president of tencent healthcare, attended the strategic cooperation signing ceremony on behalf of both parties.

 

from left: yang zhou, yanhui feng, alexander ng and yu zhang

 

with the gradual improvement, the development of digitalization in the pharmaceutical industry is moving towards more intelligence and refinement. the application of various digital technologies will play an increasingly important role in reducing costs and increasing efficiency for pharmaceutical companies. as a branch of a multinational pharmaceutical r&d company in china, the introduction of tencent healthcare’s intelligent pharmaceutical nges platform is a comprehensive upgrade of the cooperation between eisai china and tencent’s online conference scenarios. through a one-stop access to the whole scenario of academic communication with professional doctors, eisai china will realize accurate academic education with information collaboration and data interconnection to help market development and patient accessibility for innovative products in various fields such as neurology, oncology and gi related diseases.

nges is tencent health’s first saas solution for the pharmaceutical industry. with wechat as the carrier, it takes the three scenarios, crm (one-stop healthcare professionals visit), events (online and offline meeting management) and mcm (multi-channel marketing), refines the whole process of doctors-interaction. and based on wechat and other digital intelligence tools, it helps pharmaceutical companies deeply engage doctors in terms of one-stop access to doctors-interaction scenarios, reaching users while conducting two-way interaction and providing intelligent behavioral suggestions, making academic communication more convenient, smooth and efficient.

yanhui feng states: “eisai china has always adhered to the hhc (human health care) corporate philosophy and practiced the hhceco (hhc ecosystem) development model. the deepening cooperation with tencent health is an important part of the 4new strategies of ‘new products, new channels, new platforms and new business’ in china. both parties will give full play to their leading advantages in the field of cutting-edge therapies and digital technology, jointly explore innovation model for the future-oriented specialized academic communication, establish efficient information transfer and sustainable business cycle, and continuously consolidate the infrastructure construction of enterprise information development.”

alexander ng states, “the pharmaceutical industry has witnessed an accelerated pace of digital transformation amid the evolving landscape. through nges-based one-stop interactive platform, we hope to support eisai china to reshape its model to engage healthcare professionals. with the online extension of academic-based multi-channel communication, eisai china will become a more agile organization with a holistic business approach.”

in addition to the nges academicized communication platform, tencent healthcare formed a full map of digital capabilities to help transforming the pharmaceutical industry by enabling faster, more efficient, and more effective drug development and healthcare service and cloud security base. by embracing these digital technologies, pharmaceutical companies will continue to drive innovation and improve patient outcomes.

achievement of outcome indicators in fy2022 pay for success contract

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that brain health checks utilizing “nouknow®” (pronounced “noh-noh”), eisai’s digital tool for self-assessment of cognitive function, will continue to be promoted as part of the fy2023 dementia examination project, conducted by bunkyo city, tokyo.

this project is designed to encourage approximately 12,300 bunkyo city residents between the ages of 55 and 75, at a milestone of every 5 years, to have a brain health check using “nouknow”. those who have undergone the assessment can receive medical advice based on the results directly from a physician on site, and depending on the results, referrals can be made for consultations at medical institutions and support from visiting nurses.

eisai and bunkyo city, concluded a “community building partnership agreement to promote local dementia support initiatives for dementia patients and their families” in june 2015, co-promoting a variety of efforts, including the awareness activities regard to disease and health such as the dementia café, inviting medical doctors to give lectures to residents and operating a community center for intergenerational exchanges between residents.

the dementia examination project has been implemented since fy2021 as a priority policy of bunkyo city, and eisai has been providing “nouknow” and operational support for their public examinations. in fy2022, a pay for success (pfs) contract was introduced with the intention of further strengthening dementia awareness and early support, and the following outcome indicators were established. eisai was commissioned for this project and achieved both outcome indicators through promotion measures such as the “nouknow” trial event and public lectures for residents on brain health.

  • outcome indicator 1: increase brain health checks performed using “nouknow” at home, etc.
  • outcome indicator 2: increase participation in lifestyle improvement programs

in fy2022, 430 people participated in on-site examinations (measurement using “nouknow” and medical interview), of which approximately 10% led to recommendations to see a medical institution. in fy2023, eisai will continue to raise awareness of brain health among residents and contribute to early detection and support of dementia.

eisai has concluded regional cooperation agreements with local governments, medical associations, and other organizations throughout japan, and is promoting efforts to realize a dementia-inclusive society (167 locations in 45 prefectures as of march 31, 2023). in addition, eisai is collaborating with 46 other local governments including bunkyo city (in fy2022) on dementia-related projects, providing opportunities for brain health assessments tailored to local issues and promoting initiatives to establish a pathway to subsequent medical care and support. eisai will contribute to the creation of a community where citizens are aware of and check their brain health from the stage where they are in a healthy condition, and where early detection, diagnosis, and preparation for dementia are possible, aiming to realize a dementia-inclusive society where people with dementia and the people in the daily living domain can live their lives how they would like.

 

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

peripheral and central nervous system drugs advisory committee voted based on data from large global confirmatory phase 3 clarity ad clinical trial in patients living with early alzheimer’s disease

the pdufa action date for traditional approval of leqembi has been set for july 6, 2023, with designation of priority review

leqembi received accelerated approval from the fda for the treatment of early alzheimer’s disease on january 6, 2023

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that the u.s. food and drug administration’s (fda) peripheral and central nervous system drugs advisory committee (pcns) voted unanimously that the data from eisai’s phase 3 clarity ad clinical trial confirms the clinical benefit of leqembi® (lecanemab-irmb) 100 mg/ml injection for intravenous use for the treatment of alzheimer’s disease (ad). additionally, the committee members confirmed the overall benefit-risk profile of leqembi, the clinical meaningfulness of the data and discussed its use in specific subgroups, including apolipoprotein e (apoe) ε4 homozygote patients, patients requiring concomitant treatment with anticoagulant agents, and patients with cerebral amyloid angiopathy.

the unanimous decision by the panel of independent experts was based on the supplementary biologics license application (sbla) which includes data from eisai’s large global confirmatory phase 3 clarity ad trial. the clarity ad trial met its prespecified primary endpoint, demonstrating a highly statistically significant slowing of cognitive and functional decline (27%, p=0.00005) compared to placebo over 18 months. highly statistically significant treatment effects were also observed for all multiplicity-controlled secondary endpoints that examined cognition and functional changes using other validated scales. the most common adverse events (>10%) in the leqembi group were infusion reactions (leqembi: 26.4%; placebo: 7.4%), aria-h (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis: leqembi: 17.3%; placebo: 9.0%), aria-e (edema/effusion: leqembi: 12.6%; placebo: 1.7%), headache (leqembi: 11.1%; placebo: 8.1%), and fall (leqembl: 10.4%; placebo: 9.6%). infusion reactions were largely mild-to-moderate (grade 1-2: 96%) and occurred on the first dose (75%). the results of the clarity ad study were presented at the clinical trials on alzheimer’s disease (ctad) conference and simultaneously published in the peerreviewed medical journal, the new england journal of medicine.

leqembi, a humanized immunoglobulin gamma 1 (igg1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of amyloid beta (aβ), received accelerated approval on january 6, 2023, and was launched in the u.s. on january 18, 2023. the accelerated approval was based on phase 2 data that demonstrated that leqembi reduced the accumulation of aβ plaque in the brain, a defining feature of ad. its continued approval may be contingent upon verification of leqembi’s clinical benefit in the confirmatory clarity ad trial (study 301). the advisory committee agreed unanimously that study 301 verified the clinical benefit. the prescription drug user fee act (pdufa) action date for the traditional approval is july 6, 2023.

eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and eisai having final decision-making authority.

reviewed by china quality certification center, the suzhou factory of eisai china inc (hereinafter referred to as the “suzhou factory”) has successfully passed the gb/t23331-2020/iso50001: 2018 energy management system certification and obtained the certificate. this marks significant achievements in the construction of the energy management system and production energy-saving management of suzhou factory in scientific, lean and standardized aspects.

under the advocacy of the national 30/60 carbon policy and eisai’s global 30/40 carbon requirements, in august 2022, suzhou plant established an energy management team in order to better promote lean production and energy conservation and emission reduction. relevant departments conducted a comprehensive variance analysis against the energy management system standard, actively formulated energy improvement plans, and implemented and completed the implementation and documentation of the energy management system. in march 2023, suzhou plant completed the audit by the expert team of china quality certification center, which highly evaluated the achievements of suzhou plant in energy management and successfully passed the energy management system certification and obtained the certification.

suzhou plant will take the energy management system certification as an opportunity to continue to promote lean and efficient production, guide the construction of a green and sustainable “zero carbon” factory, and strive to put into practice the “hhc” (human health care) corporate philosophy of caring for human health, to better reflect corporate social responsibility.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today a total of eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: dayvigo®), will be given at the 37th annual meeting of the associated professional sleep societies (sleep 2023), to be held from june 3 to 7, 2023 in indianapolis, in, the united states.

major poster presentations include new data about the effects of lemborexant on obstructive sleep apnea (poster numbers: #298, 299 and 300).

eisai considers neurology, including insomnia, a therapeutic area of focus. eisai strives to create innovative products as soon as possible in therapeutic areas with high unmet medical needs, and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with neurological diseases and their families.

after four years of follow-up, lenvima plus keytruda reduced the risk of death by 21% versus sunitinib in the pivotal phase 3 clear (study 307)/keynote-581 trial
final results will be presented at asco 2023 in an oral abstract session

 

tokyo and rahway, n.j., may.26, 2023 – eisai (headquarters: tokyo, ceo: haruo naito) and merck & co., inc., rahway, nj, usa (known as msd outside of the united states and canada) today announced data from the final pre-specified overall survival (os) analysis of the pivotal phase 3 clear (study 307)/keynote-581 trial investigating lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus keytruda, merck’s anti-pd-1 therapy, for the first-line treatment of patients with advanced renal cell carcinoma (rcc). these data will be presented on monday, june 5 at 11:54 a.m. central daylight time during an oral abstract session at the 2023 american society of clinical oncology (asco) annual meeting (abstract #4502).

after four years of follow-up, lenvima plus keytruda maintained a clinically meaningful os benefit versus sunitinib, reducing the risk of death by 21% (hr=0.79 [95% ci, 0.63-0.99]). the 24- and 36-month estimated os rates were 80.4% and 66.4% for lenvima plus keytruda versus 69.6% and 60.2% for sunitinib, respectively. results from the final pre-specified os analysis were consistent with the superior results versus sunitinib from the primary os analysis of the clear/keynote-581 trial.

additionally, lenvima plus keytruda reduced the risk of disease progression or death by 53% (hr=0.47 [95% ci, 0.38-0.57]), with a median progression-free survival (pfs) of 23.9 months (95% ci, 20.8-27.7) for lenvima plus keytruda versus 9.2 months (95% ci, 6.0-11.0) for sunitinib; the objective response rate (orr) was 71.3% (95% ci, 66.6-76.0) with a complete response (cr) rate of 18.3% for lenvima plus keytruda versus an orr of 36.7% (95% ci, 31.7-41.7) with a cr rate of 4.8% for sunitinib.

there were no new safety signals and the safety profile at the final os analysis was consistent with the primary analysis. grade ≥3 treatment-related adverse events (trae) occurred in 74.1% of patients who received lenvima plus keytruda versus 60.3% of patients who received sunitinib. the six most common traes of any grade of patients in the lenvima plus keytruda arm were diarrhea (56.0%), hypertension (54.3%), hypothyroidism (44.9%), decreased appetite (35.5%), fatigue (34.1%) and stomatitis (32.7%). in the sunitinib arm, the six most common traes of any grade were diarrhea (45.3%), hypertension (40.3%), stomatitis (37.4%), palmar-plantar erythrodysesthesia (36.2%), fatigue (32.9%) and nausea (28.2%).

“lenvima plus keytruda continues to demonstrate durable clinical benefit as a first-line treatment for patients with advanced renal cell carcinoma, as shown by the clinically meaningful improvement in overall survival sustained with four years of follow up,” said dr. thomas hutson, do, pharm.d., facp, director of the urologic oncology program and co-chair of the urologic cancer research and treatment center, texas oncology at baylor sammons cancer center. “furthermore, these data also showed clinically meaningful improvements in median pfs and orr compared to sunitinib. these findings reinforce the important role of lenvima plus keytruda as a first-line standard of care treatment option for patients with advanced renal cell carcinoma.”

“long-term follow up data from the clear/keynote-581 trial show the responses to first-line use of keytruda plus lenvima were durable for many of these patients,” said dr. gregory lubiniecki, vice president, global clinical development, merck research laboratories. “through our joint clinical development program with eisai, we’re continuing to advance our research evaluating keytruda plus lenvima for other challenging cancers as we strive to help even more patients.”

“at the final pre-specified analysis, lenvima plus keytruda continued to demonstrate clinically meaningful efficacy across pfs, orr and os, providing patients and their physicians with new information about treating people living with advanced renal cell carcinoma,” said corina dutcus, m.d., senior vice president, clinical development, oncology at eisai inc. “these results are a testament to our steadfast commitment to people living with advanced cancers, and we are grateful for the support from the patients, families and healthcare provider community for their participation in this research.”

lenvima plus keytruda is approved in the u.s., the eu, japan and other countries for the treatment of advanced rcc and certain types of advanced endometrial carcinoma. lenvatinib is marketed as kisplyx® for advanced rcc in the eu. eisai and merck are studying the lenvima plus keytruda combination through the leap (lenvatinib and pembrolizumab) clinical program in various tumor types, including but not limited to endometrial carcinoma, hepatocellular carcinoma, non-small cell lung cancer, rcc, head and neck cancer, gastric cancer and esophageal cancer across multiple clinical trials.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it will grant a total of 625 million yen to the global health innovative technology fund (“ghit fund”) to fund the third phase of its activities, which will take place in the five-year period from fy2023 to fy2027. the ghit fund is a public-private partnership, co-established in april 2013 by partners such as japanese pharmaceutical companies (including eisai), the japanese government, and the bill & melinda gates foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in japan and overseas. eisai has provided a total of 1 billion yen to the first phase (fy2013 – fy2017) and the second phase (fy2018 – fy2022) of the ghit fund.

in order to develop treatments for the numerous people suffering from infectious diseases such as neglected tropical diseases (ntds) and malaria in developing and emerging countries, there are disease-specific development and marketability issues to overcome. it is also necessary to establish local supply systems and help patients secure access to diagnosis and treatments. the key to overcoming these challenges are industry-government-academia partnerships which transcend the usual sector boundaries.

eisai considers making efforts to resolve the global issue of access to medicines to be its duty. under a public-private partnership including governments, international organizations, and private non-profit organizations, eisai has participated in 23 joint research projects to develop new medicines and vaccines for mycetoma, malaria and filariasis, with the support of the ghit fund.

eisai has conducted a phase ii clinical trial of its in-house developed agent e1224 (generic name: fosravuconazole) in sudan for the treatment of mycetoma in partnership with the non-profit organization drugs for neglected diseases initiative (dndi). eisai is also conducting a phase ii clinical trial of antimalarial agent sj733 in collaboration with the university of kentucky.

eisai considers efforts for improving access to medicines, such as the elimination of ntds and malaria, as activities aimed at creating long-term corporate value and social impact based on its corporate concept of human health care (hhc). we will continue to strengthen cooperation with our global partners and contribute to “relieving anxiety over health” and “reducing health disparities” for people at risk of infection with ntds and those suffering from theses diseases.

 

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the 2023 american society of clinical oncology (asco) annual meeting (#asco23), which is taking place virtually and in-person in chicago, illinois from june 2 to 6.

notable research includes an oral presentation of results from the final pre-specified overall survival analysis of the pivotal phase 3 clear (study 307)/keynote-581 trial, which evaluated lenvatinib (lenvima®) plus pembrolizumab (keytruda®) versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (abstract #4502). a post hoc analysis from the reflect trial evaluating lenvatinib monotherapy versus sorafenib in the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc) will also be shared in a poster presentation (abstract #4078).

“the outlook for advanced renal cell carcinoma has evolved in recent years, and the final analysis from the pivotal clear trial to be presented at asco represents another step forward for patients and an opportunity to provide their physicians with long-term data,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “new data for lenvatinib and from our oncology pipeline showcase eisai’s continued commitment to driving innovation and exploring novel therapeutic modalities in our ambition to live out our human health care concept, our corporate mission to meet the needs of more people who face a cancer diagnosis.”

additional data from eisai’s pipeline include a poster presentation of findings from a phase 1b study of e7386, a creb-binding protein (cbp) / β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced hcc (abstract #4075), and the small cell lung cancer cohort of a phase 1b/2 trial evaluating e7389-lf, a new liposomal formulation of eribulin, in combination with nivolumab (abstract #8593). insights from preclinical testing of farletuzumab ecteribulin (fzec), formerly known as morab-202, and morab-109, antibody drug conjugates (adc), in rare gynecologic cancers will also be published online (abstract # e17634).

furthermore, bliss biopharmaceutical co., ltd. (blissbio) will present a poster at the conference with results from the first-in-human study of bb-1701, a her2-targeting adc (abstract #3029). eisai entered into a joint development agreement with blissbio for bb-1701 with option rights for a strategic collaboration in april 2023. a phase 1/2 clinical study of bb-1701 in the u.s. and china for her2-expressing solid tumors is currently underway.

this release discusses investigational compounds and investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational compounds or investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

the full list of presentations is included below. these abstracts will be made available on thursday, may 25, 2023 at 4:00 pm central daylight time (cdt).

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

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