Tokio Marine & Nichido Fire Insurance Co., Ltd. (Headquarters: Tokyo, CEO: Shinichi Hirose, “Tokio Marine Nichido”) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that they have co-developed “Dementia Care Support Insurance” to financially support early detection and early treatment for dementia as a part of their business alliance for the realization of a Dementia Inclusive Society.
1. Background
Tokio Marine Nichido and Eisai concluded a business alliance agreement for the realization of a Dementia Inclusive Society in August 2019, and the two companies have promoted initiatives to achieve this purpose, including the provision since April 2021 of “NouKNOW®※1”, a digital tool for self-assessment of cognitive function developed by Eisai, as an ancillary service for “Long-term care indemnity (installment payment)”, sold by Tokio Marine Nichido.
Dementia was thought to be difficult to treat, but with the approval of a new drug for Alzheimer’s disease, which accounts for 60% of dementia cases, and the hope of slowing disease progression by starting treatment in the early stages of disease, the preparation for early detection and early treatment is becoming increasingly important.
Amid such circumstances, the two companies co-developed a new insurance product, “Dementia Care Support Insurance” to financially support early detection and early treatment of the disease, with the expertise Tokio Marine Nichido has developed through dealing with insurance products and related services and Eisai’s extensive experience in the field of dementia.
※1 A tool for checking brain reaction speed, attention, visual learning and memory through four types of simple tests with images of playing cards on a PC, tablet, or smartphone. (Not a medical device)
2. Overview of (Industry’s First※2) “Dementia Care Support Insurance”
(1) Details of Coverage/Service
The new treatment is indicated for patients with mild cognitive impairment and mild cognitive impairment due to Alzheimer’s disease, but determination of eligibility requires medical tests, including a PET scan, to confirm amyloid-β pathology. Since these tests and treatments require a certain level of out-of-pocket expenses, the following coverage will be provided for financial support.
① Lump-sum benefit for mild cognitive impairment (Support for early detection)
In the event of the first diagnosis of mild cognitive impairment (including dementia), a lump sum benefit for the purpose of covering costs for amyloid PET tests, etc. is provided.
② Lump-sum benefit for mild cognitive impairment due to Alzheimer’s disease (Support for early stage treatment)
In the event of the first diagnosis of mild cognitive impairment due to Alzheimer’s disease (including dementia due to Alzheimer’s), a lump-sum benefit for the purpose of covering medical costs for treatment with the new drug is provided.
Additionally, the policy provides the opportunity to use “NouKNOW” as an ancillary service, ensuring the support of early detection and early treatment by identifying cognitive decline.
※2 The first coverage in the non-life insurance industry focusing on mild cognitive impairment due to Alzheimer’s disease and dementia due to Alzheimer’s disease (according to a survey conducted by Tokio Marine Nichido) ※3 May vary depending on terms of contract
(2) Process Upon Signing The Policy
Potential policy holders need to complete a “NouKNOW” test to purchase the policy, along with completing a Statement of Health form.
(3) Insurance Premium
Monthly 1,370 yen (in the case of a male aged 50 to 54 years receiving a 300,000 yen lump-sum benefit for mild cognitive impairment, and 1 million yen for mild cognitive impairment due to Alzheimer’s disease). *May vary depending on terms of contract
(4) Type of Policy
A group insurance in which a large-scale entity, such as a company, purchases the policy and its members voluntarily purchase the coverage through the entity.
3. Future Perspectives Tokio Marine Nichido and Eisai will further promote efforts to resolve various social challenges by expanding our network through collaboration with various companies and organizations, to realize a Dementia Inclusive Society.
Eisai Co., Ltd. (Head office: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has launched a new “Innovation” page on its corporate website. The “Innovation” page is comprised of four sections: “Research & Development (R&D),” “Ecosystem,” “Open Innovation,” and “Corporate Venture Capital,” which are the core of Eisai’s innovation creation. Each part introduces information such as Eisai’s strengths, originality, and the status of specific initiatives.
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept, (also known as our human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities.
On the newly established “Innovation” page, Eisai has enhanced information on policies, characteristics, and examples of initiatives for innovation creation aimed at realizing it’s corporate concept. The “R&D” section contains new contents, such as an overview of the Deep Human Biology Learning (DHBL) drug discovery and development system, which was established last year, track records of Eisai’s long-term commitment to dementia, oncology and tropical diseases, and the current status of digital technology application in R&D settings. In addition, the “Ecosystem” section explains Eisai’s policy of evolving into an hhceco(hhc concept + ecosystem) company to empower people to “realize their fullest lives” how they would like, from the time that they are in good health up to their final moments, and the dementia hhceco model on which Eisai is focusing. Moreover, the “Open Innovation” and “Corporate Venture Capital” sections introduce their respective business policies and achievements, and an inquiry page for new partnering opportunities has been established.
Eisai will continue to disclose information in a proactive and easy-to-understand manner through our corporate website and communicate with all of our stakeholders to help them understand our corporate concept and business activities.
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OKYO and CAMBRIDGE, Mass., September 25, 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 humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI® Intravenous Infusion” (200 mg, 500mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD).
LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of Aβ. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline by selectively binding to and eliminating the most toxic Aβ aggregates (protofibrils) that contribute to neurotoxicity in AD. In Japan, an application for marketing approval was filed and was designated for priority review in January 2023. Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.
LEQEMBI’s 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). In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of 37% compared to placebo. The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10%) in the LEQEMBI group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. 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.
“Today LEQEMBI received approval, making it the first 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 in Japan. We believe that we have turned a new page in the history of Alzheimer’s disease treatment. Alzheimer’s disease is a progressive and serious disease that not only causes significant impairment and burden for the people living with it and their care partners, but also has a tremendous impact on society as a whole,” said Haruo Naito, Chief Executive Officer at Eisai. “For around 40 years since we began research on dementia at our Tsukuba Research Laboratories, Eisai has interacted with people with dementia and their care partners, and made efforts to understand their sincere feelings. In response, we have been taking on the challenge to develop therapeutic agents that act on the underlying pathology of Alzheimer’s disease. We are committed to delivering LEQEMBI to the people with early Alzheimer’s disease who need it and their families as a new treatment that removes the cause of the disease. Through these efforts, we aim to create impact on issues surrounding dementia in Japanese society.”
“With this approval, alongside Eisai, we will be able to help address the devastating impact Alzheimer’s has on people living with the condition as well the emotional, social and financial burden it places on care partners,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. “This is a significant step in the work of Biogen and Eisai to usher in a new era of treatments for this disease which impacts millions. We look forward to working alongside Eisai to build on the approvals in the U.S. and now Japan to bring this option to patients and their families worldwide.”
Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered LEQEMBI until data from a certain number of patients are accumulated after market launch, in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare. In addition, the appropriate use of LEQEMBI will be promoted in accordance with the package insert and training materials will be developed for healthcare professionals to assist the management and monitoring of amyloid-related imaging abnormalities (ARIA).
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. In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.
*Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.1,2,3.
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1. Product Outline in Japan 1) Product name
LEQEMBI® Intravenous Infusion 200mg, LEQEMBI® Intravenous Infusion 500mg
2) Generic name
Lecanemab (recombinant)
3) Indication for use
Slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease.
4) Dosage and administration
The usual dose of lecanemab (recombinant) is 10mg/kg infused intravenously over approximately 1 hour, once every 2 weeks.
2. About LEQEMBI LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer’s disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI accelerated approval on January 6, 2023, and traditional approval on July 6, 2023. In the U.S., treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
Eisai has also submitted applications for approval of lecanemab in EU, China, Canada, Great Britain, Australia, Switzerland, South Korea and Israel. In China and Israel, the applications have been designated for priority review, and in Great Britain, lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.
Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE). A maintenance dosing regimen has been evaluated as part of Study 201.
Since 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, is ongoing. 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 AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen.
Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.
3. About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
4. About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market LEQEMBI for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody LEQEMBI back-up was signed in May 2015.
5. About Eisai Co., Ltd. Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter, LinkedIn and Facebook.
6. About Biogen Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.
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 LEQEMBI; the potential benefits, safety and efficacy of LEQEMBI; potential regulatory discussions, submissions and approvals and the timing thereof; 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 LEQEMBI; 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 studies may not be indicative of full results or results from later stage or larger scale clinical studies 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 studies, including the Clarity AD clinical trial and AHEAD 3-45 study; 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 LEQEMBI; actual timing and content of submissions to and decisions made by the regulatory authorities regarding LEQEMBI; uncertainty of success in the development and potential commercialization of LEQEMBI; 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.
2. Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2):e32014. https://doi.org/10.1371/journal.pone.0032014 Epub 2012 Feb 15. PMID: 22355408; PMCID: PMC3280222.
3. Söderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab — Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics. 2023;20:195-206. https://doi.org/10.1007/s13311-022-01308-6
TOKYO and RAHWAY, N.J., Sept. 22, 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 provided updates on two Phase 3 trials, LEAP-006 and LEAP-008, evaluating LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA in patients with certain types of metastatic non-small cell lung cancer.
LEAP-006: The Phase 3 LEAP-006 trial evaluating LENVIMA plus KEYTRUDA in combination with pemetrexed (Alimta®) and platinum-containing chemotherapy versus KEYTRUDA with pemetrexed and platinum-containing chemotherapy, a current standard of care option in this disease setting, as a first-line treatment for adult patients with metastatic, nonsquamous non-small cell lung cancer (NSCLC) who have confirmation that epidermal growth factor receptor (EGFR)–,anaplastic lymphoma kinase (ALK)- or c-ros oncogene 1 (ROS1)- directed therapies are not indicated, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). At the study’s final analysis, there was not an improvement in OS for patients treated with KEYTRUDA plus LENVIMA with chemotherapy compared to KEYTRUDA with chemotherapy. Earlier interim analyses did not demonstrate a statistically significant improvement in PFS or objective response rate (ORR), a key secondary endpoint.
LEAP-008: The Phase 3 LEAP-008 trial evaluating LENVIMA plus KEYTRUDA versus docetaxel, a current second line standard of care option, as a treatment for patients with metastatic NSCLC who progressed on or after platinum-containing chemotherapy and one prior anti-PD-1/-L1 immunotherapy, and have confirmation that EGFR-, ALK- or ROS1-directed therapies are not indicated, did not meet its dual primary endpoints of OS and PFS. At the final analysis of the study, there was not an improvement in OS for patients who received KEYTRUDA plus LENVIMA compared to docetaxel. Earlier interim analyses did not demonstrate a statistically significant improvement in PFS or ORR, a key secondary endpoint.
In both the LEAP-006 and LEAP-008 trials, the safety profiles of the LENVIMA plus KEYTRUDA-based treatment regimens were consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from these studies is ongoing. The companies will work with investigators to share the results with the scientific community.
“As a leader in lung cancer research, we continue to try to advance science for our patients by building upon the standard we set several years ago with KEYTRUDA,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “While these results are not what we hoped for, we are proud of the foundational role that KEYTRUDA has established in the treatment of certain types of lung cancer, and we are committed to continuing to research how we can further improve responses to our medicines for patients with difficult-to-treat forms of the disease.”
“Despite great progress in recent years, unmet needs still remain in the treatment of patients with metastatic non-small cell lung cancer, particularly for those without targetable biomarkers,” said Dr. Corina Dutcus, Senior Vice President, Global Clinical Development, Oncology at Eisai Inc. “KEYTRUDA plus LENVIMA has demonstrated survival benefit in advanced renal cell carcinoma and advanced endometrial carcinoma, and while we are disappointed that the final analyses of these non-small cell lung cancer studies did not show the same benefit, we remain committed to applying learnings from these studies and furthering research in oncology for people with unmet needs. We thank all the patients, their families and the investigators involved.”
LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. Lenvatinib is marketed as KISPLYX® for advanced RCC in the EU. Eisai and Merck & Co., Inc., Rahway, NJ, USA 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, RCC, head and neck cancer, gastric cancer and esophageal cancer across multiple clinical trials.
Results from the LEAP-006 and LEAP-008 trials do not affect the current approved indications for the LENVIMA and KEYTRUDA combination or other ongoing trials from the LEAP clinical program.
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About LEAP-006 LEAP-006 is a randomized, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT03829319) evaluating LENVIMA plus KEYTRUDA with pemetrexed and platinum-containing chemotherapy versus placebo plus KEYTRUDA with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with metastatic, nonsquamous NSCLC who have confirmation that EGFR-, ALK- or ROS1-directed therapies are not indicated. The dual primary endpoints are PFS, as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and OS. Secondary endpoints include ORR and duration of response (DOR), as assessed by BICR per RECIST v1.1, quality of life and safety. The study enrolled an estimated 748 patients who were randomized 1:1 to receive:
• LENVIMA (8 mg orally once daily) plus KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle [Q3W]) with pemetrexed 500 mg/m2 IV Q3W and carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m2 Q3W IV; or
• Placebo (oral capsule once daily) plus KEYTRUDA (200 mg IV Q3W) with pemetrexed 500 mg/m2 IV Q3W and carboplatin AUC5 or cisplatin 75 mg/m2 Q3W IV
All study drugs were continued until protocol-specified discontinuation criteria. KEYTRUDA was administered for up to 35 cycles (approximately two years). After completing two years of combination therapy, LENVIMA may have been administered as a single agent until protocol-specified discontinuation criteria were met.
style=”font-size: 1.6rem;”>Carboplatin or cisplatin was administered for up to four cycles. The LEAP-006 study was conducted in collaboration with Eli Lilly and Company, the makers of Alimta® (pemetrexed).
About LEAP-008 LEAP-008 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT03976375) evaluating LENVIMA plus KEYTRUDA versus docetaxel for the treatment of patients with metastatic NSCLC who progressed on or after platinum-containing chemotherapy and one prior anti-PD-1/-L1 therapy, and have confirmation that EGFR-, ALK- or ROS1-directed therapies are not indicated. The trial’s dual primary endpoints are PFS, as assessed by BICR per RECIST v1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and OS. Secondary endpoints include ORR and DOR as assessed by BICR per RECIST v1.1, quality of life and safety. The study enrolled an estimated 422 patients who were randomized 4:4:1 to receive:
• LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg IV every three-weeks); or
• Docetaxel (75 mg/m2 IV every three-weeks); or|
• LENVIMA (24 mg orally once daily).
KEYTRUDA was administered for up to 35 cycles (approximately two years) or until protocol-specified discontinuation criteria were met. After completing two years of combination therapy, LENVIMA may have been administered as a single agent until protocol-specified discontinuation criteria were met.
About lung cancer Lung cancer is the leading cause of cancer death worldwide.1 In 2020 alone, there were more than 2.2 million new cases and 1.8 million deaths from lung cancer globally.2 Non-small cell lung cancer is the most common type of lung cancer in the U.S., accounting for about 81% of all cases. 3 In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 25%, which is a 21% improvement over the last five years.4 Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures as well as the introduction of new therapies. 3 Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced. 4 Only 5.8% of people in the U.S. who are eligible were screened for lung cancer in 2021. 4
About LENVIMA® (lenvatinib) Capsules LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine 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. LENVIMA has been approved for the indications below.
Thyroid cancer • Indication as monotherapy
(Approved in over 80 countries including Japan, the United States, China, and countries in Europe and Asia)
Japan: Unresectable thyroid cancer
The United States: The treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer (DTC)
Europe: The treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI)
Hepatocellular carcinoma • Indication as monotherapy
(Approved in over 80 countries including Japan, the United States, China, and countries in Europe and Asia)
Japan: Unresectable hepatocellular carcinoma
The United States: The first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Europe: The treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
Thymic carcinoma • Indication as monotherapy (Approved in Japan)
Japan: Unresectable thymic carcinoma
Renal cell carcinoma (In Europe, the agent was launched under the brand name Kisplyx®)
• Indication in combination with everolimus
(Approved in over 65 countries including the United States, and countries in Europe and Asia)
The United States: The treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
Europe: The treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy
• Indication in combination with KEYTRUDA (generic name: pembrolizumab)
(Approved in over 45 countries including Japan, the United States, and countries in Europe and Asia)
Japan: Radically unresectable or metastatic renal cell carcinoma
The United States: The first-line treatment of adult patients with advanced renal cell carcinoma
Europe: The first-line treatment of adult patients with advanced renal cell carcinoma
Endometrial carcinoma • Indication in combination with KEYTRUDA
(Approved [including conditional approval] in over 50 countries including Japan, the United States, and countries in Europe and Asia)
Japan: Unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy
The United States: The treatment of patients with advanced endometrial carcinoma (EC) 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.
Europe: The treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery
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., Rahway, NJ, USA 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., Rahway, NJ, USA Strategic Collaboration In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA, 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., Rahway, NJ, USA.
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 various tumor types across multiple clinical trials.
Eisai’s Focus on Cancer Eisai acknowledges “Oncology” as one of its key strategic areas, and will continue to focus on the discovery and development of anti-cancer drugs within drug discovery domains including “microenvironment”, “proteostasis disruption”, “cell lineage and cell differentiation”, and “inflammation, hypoxia, oxidative stress and cell senescence” under the Deep Human Biology Learning (DHBL) drug discovery and development organization. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.
About Eisai Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.S. and global), LinkedIn (for global, U.S. and EMEA) and Facebook (global).
Merck & Co., Inc., Rahway, NJ, USA’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., Rahway, NJ, USA, 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., Rahway, NJ, USA 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 www.merck.com/clinicaltrials.
About Merck & Co., Inc., Rahway, NJ, USA For over 130 years, Merck & Co., Inc., Rahway, NJ, USA, 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., Rahway, NJ, USA 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 www.merck.com and connect with us on Twitte, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, NJ, USA This news release of Merck & Co., Inc., Rahway, NJ, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today on World Alzheimer’s Day, that it has released a dementia awareness video, “Life Goes On 2023: Two Memories, One Story”, on its dementia information website “Sodan.e-65” and YouTube, which are intended to deepen the understanding of dementia.
With the rapidly aging population, it is predicted that by 2025, one in five people over the age of 65 in Japan will have dementia,1 and dementia is now something that is familiar to everyone. Symptoms of dementia vary depending on the individual and the disease type that causes it, but the first step toward relieving anxiety of the patient is for others around them to understand their thoughts and the reason behind their symptoms, and to dispel any misunderstandings or assumptions.
This video was produced based on the concept of “learning helps us to be kind”, with the aim of realizing a society where people with dementia and their families can live with peace of mind, by deepening society’s understanding of the disease.
In fiscal 2022, we released “Life Goes On: No Way It’s Not Here” and “Life Goes On: Timeslip”, which depict daily life from the perspective of a mother diagnosed with dementia and her daughter, and have received inquiries from more than 80 local governments, such as requests to use the videos at events.
Life Goes On 2023: Two Memories, One Story
The two met, grew up, became a couple, and started a family. Time passes, and one day the husband forgets if he had eaten or not. The wife notices this and is bewildered.
A story of a couple and their family accepting life with dementia and moving forward.
Eisai will continue to contribute to realize a Dementia Inclusive Society where no one is left behind through creating social impact by building a dementia ecosystem via collaboration with local governments and other industries.
Media Inquiries: Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
[Notes to Editors] 1. About World Alzheimer’s Day In 1994, Alzheimer’s Disease International, in collaboration with the World Health Organization, established September 21 every year as “World Alzheimer’s Day” to raise awareness of dementia. In addition, since 2012, September has been designated as “World Alzheimer’s Month,” and various efforts are being made around the world. In Japan, non-profit organization Alzheimer’s Association Japan has been conducting activities such as creating posters and leaflets to promote understanding of dementia.
2. About “Life Goes On 2023: Two Memories, One Story” 【Out-of-home Advertising Campaign】
Over the course of 10 days from September 21 (Thursday) to September 30 (Saturday), a full-page hanging advertisement will be displayed all across one train on the Marunouchi Line of the Tokyo Metro.
【Making of the Video】
Another “Two Memories, One Story”
– Towards a society where everyone can live a better life –
The entire production staff worked on the filming process with the hope of creating an opportunity to think about “the person” before the disease, and to close the distance between society and dementia.
【Production Storyboard】
A blueprint of the video, that features the movements and emotions of the characters,
how to direct the scene, etc.
Further details of the husband’s dementia symptoms and psychological changes are also described in the movies.
3. About Dementia Information Site “Sodan.e-65” In addition to the “Forgetfulness Consultation Navigator,” which allows users to search for medical institutions that provide consultation and treatment for dementia, the dementia information site “Sodan.e-65” provides information for everyone living with dementia, including basic knowledge about dementia, measures to maintain and improve cognitive function, care methods, personal experiences, and the dual-task exercise program “Brepacise” (brain performance + exercise) that stimulates both the body and brain. Please see https://e-65.eisai.jp/ for details (in Japanese only)
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has established a digital business company Theoria technologies Co., Ltd. (“Theoria technologies”) which will accelerate the development of a dementia ecosystem. Theoria technologies is a wholly owned subsidiary of Eisai.
With the aim of relieving the anxieties of people with dementia and their families and addressing social issues, Eisai is not only creating therapeutic drugs, but also working to build a dementia ecosystem through the development of digital solutions and collaboration with other industries. Theoria technologies will serve as the core of a highly transparent and neutral dementia platform, and the foundation for the development of an ecosystem to empower the people with dementia, regardless of the type or stage of the disease, to “live their fullest lives”.
Theoria technologies will accelerate decision-making and strengthen the hiring and training of digital talent under an organizational structure optimized for digital business, and will utilize clinical study data that Eisai has accumulated over many years as well as cohort study data, Personal Health Records (PHR), and other data to develop various prediction algorithms, create digital solutions and provide data. Theoria technologies will commence business activities in April 2024, with the aim of providing services for a risk prediction algorithm for early detection of mild cognitive impairment (MCI) and dementia in FY2024. In addition, together with Eisai, Theoria technologies will develop and provide Sasaeru, an application that helps facilitate communication between people with dementia, doctors, and caregivers by recording Activities of Daily Living (ADL) of the people with dementia. Furthermore, Theoria technologies will promote the development of digital services by strengthening collaboration with other companies.
Eisai is aiming to create social impact by realizing a Dementia Inclusive Society where people with dementia and the people in the daily living domain can live their lives how they would like, through the development of an ecosystem.
Media Inquiries: Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
[Notes to Editors] 1. About Theoria technologies Co., Ltd.
1) Company Name:
Theoria technologies Co., Ltd.
2) Location:
4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan
3) Representative:
Ryo Jokura
4) Scope of Business:
Provision of services utilizing medical and health-related data, other healthcare-related services
5) Charter Capital:
350 million JPY
6) Date of Establishment:
September 4, 2023
<Business Model>
2. About algorithms for predicting the risk of developing mild cognitive impairment (MCI) and dementia for early detection For MCI and dementia, there is a challenge that patients might be unaware of the progression of their symptoms leading to a delay in consultation and diagnosis. By enabling people with dementia to predict their own condition, it is hoped that it will lead to greater implementation of prevention activities and that greater action will be taken toward early diagnosis. The service is aimed for launch in fiscal 2024.
3. About Sasaeru, a communication application for doctors, caregivers and people with mild cognitive impairment (MCI) and dementia
Sasaeru is an application developed by Eisai that records Activities of Daily Living (ADL), which is important information in the treatment of dementia, and allows users to visually capture changes in ADL. Its purpose is to resolve problems with communication in the field of dementia care between doctors, caregivers, and people with dementia. The service launch was announced in May 2023 at the Japan Academy for Alzheimer’s Disease, an academic research society of dementia specialists. From 2024, as a Theoria technologies service and in collaboration with Eisai, proof of concept research will be conducted at even more medical institutions to build evidence and promote nationwide development within Japan.
Values are an integral part of our foundation. With every decision, we ensure that we follow:
Integrity
Integrity is the living up to legal, moral and ethical principles in the conduct of HI-Eisai Pharmaceutical Inc. business. It means that each employee embodies the value of integrity, and therefore represents the company in honesty and rectitude in all the ways they do their work.
It is expected that each employee would make decisions guided by good judgement, not just for one‘s self, but for HI-Eisai as the company. An employee who acts with integrity ensures that he has understanding of the principles by which the company operates, and in situations where he lacks clarity, will actively seek guidance.
Respect
The company is committed to ensure that it maintains a safe, inclusive, and healthy working environment that promotes productivity among employees. All employees are expected to show respect to fellow employees, customers, and patients, regardless of differences in gender, culture, backgrounds, and beliefs. Leaders in the organization are likewise expected to promote inclusivity with their teams, and shall not tolerate any discriminatory and offensive actions.
Accountability
Accountability at work means assuming responsibility for the business outcome and how that is achieved. It means that every employee, in whichever position, are equally responsible for the decisions and actions they make for the company. It is likewise, the responsibility of each employee to report, any knowledge of misconduct or potential violation to the company‘s rules and regulations.
Patient-Centric
At the heart of the company‘s operation are the patients. This means that every decision to be made, considers the potential impact and benefit to the patients. As such, the company commits itself in ensuring that business objectives align with its principle of human health care or hhc. The programs created and implemented are based on how well they could contribute to improving patients‘ lives.
For field-based employees, being patient-centric means that the focus of engagements with customers are on understanding patient needs as well as providing these stakeholders with comprehensive information on how HI-Eisai‘s products can support their patients goals.
For each employee, being patient-centric means taking on their responsibilities with care and consideration on how it impacts the patients experience, be it by making relevant information readily available for the doctors; or by ensuring access and availability to the medicines we offer.
Excellence
As a patient-centric company, we define Excellence by the outstanding quality of our work to improve patients‘ lives. Each employee is expected to consistently demonstrate work ethics that align to our values, policies, and our desire to provide above standard service. The company is committed in ensuring that all actions are in compliance with legal requirements.
Being excellent means that every employee passionately strives to be better and participates in the company‘s initiatives to develop their members in terms of knowledge, skills, and behavior, which will support a continuously improving, responsible and performance-driven workforce.
Our Vision
To be a successful and sustainable business in the Philippines by driving innovation and providing solutions to address unmet healthcare needs fueled by high-performing employees who deliver meaningful value and experience to patients and their families.
Our Mission
We give first thought to patients and their families, and to increasing the benefits health care provides.
