Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 Trials of LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Certain Patients With Advanced Melanoma (LEAP-003) and Metastatic Colorectal Cancer (LEAP-017)

by codm | Mar 22, 2024 | Newsletter

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TOKYO and RAHWAY, N.J., Apr. 7, 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-003 and LEAP-017 investigating 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.

LEAP-003: Eisai and Merck & Co., Inc., Rahway, NJ, USA are discontinuing the Phase 3 LEAP-003 trial evaluating LENVIMA plus KEYTRUDA for the first-line treatment of adults with unresectable or metastatic melanoma. This decision is based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis and determined LENVIMA plus KEYTRUDA did not demonstrate an improvement in overall survival (OS), one of the study’s dual primary endpoints, versus KEYTRUDA alone. Eisai and Merck & Co., Inc., Rahway, NJ, USA are informing study investigators of the decision and advising them to reach out to patients in the study regarding treatment. At an earlier interim analysis, the trial’s other dual primary endpoint, progression-free survival (PFS), showed a statistically significant improvement in the LENVIMA plus KEYTRUDA arm versus the KEYTRUDA plus placebo arm.

LEAP-017: The Phase 3 LEAP-017 trial evaluating LENVIMA plus KEYTRUDA did not meet its primary endpoint of OS for the treatment of patients with unresectable and metastatic colorectal cancer that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H) who experienced disease progression on, or became intolerant to, prior therapy. In the final pre-specified analysis of OS, a trend toward improvement was observed with LENVIMA plus KEYTRUDA versus regorafenib or TAS-102 (trifluridine and tipiracil hydrochloride); however, these results did not meet statistical significance per the pre-specified statistical analysis plan. A trend toward improvement was also observed in key secondary endpoints of PFS, objective response rate (ORR) and duration of response (DOR) with LENVIMA plus KEYTRUDA versus regorafenib or TAS-102; however, per the pre-specified statistical analysis plan, these results were not tested for statistical significance.

In both the LEAP-003 and LEAP-017 trials, the safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported data on the combination. A full evaluation of the data from these studies including pre-planned key subgroup analyses is ongoing. The companies will work with investigators to share the results with the scientific community.

“We are grateful to all the investigators, patients and their families for their participation in these studies, and we will continue to evaluate KEYTRUDA plus LENVIMA across different types of cancer where additional treatment options are needed. We remain fully committed to building on existing treatments, as part of our efforts to help as many appropriate patients with cancer as we can,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck & Co., Inc., Rahway, NJ, USA Research Laboratories.

“With the LEAP-003 and LEAP-017 trials, we set out to help improve outcomes for patients with two difficult-to-treat advanced cancers, melanoma and colorectal cancer,” said Corina Dutcus, M.D., Senior Vice President, Clinical Development, Oncology at Eisai Inc. “While these results are different from our initial expectation, insights from both studies will help contribute to our understanding of LENVIMA plus KEYTRUDA. We remain confident in LENVIMA as a pillar of Eisai’s oncology portfolio and will continue to evaluate its potential in ongoing trials within the LEAP program.”

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. Results from the LEAP-003 and LEAP-017 trials do not affect the current approved indications for the LENVIMA and KEYTRUDA combination.

Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in multiple tumor types, including but not limited to endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, head and neck cancer, colorectal cancer, gastric cancer and esophageal cancer, across more than 10 clinical trials.

Media Contacts:

About LEAP-003

LEAP-003 is a randomized, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT03820986) evaluating LENVIMA plus KEYTRUDA versus KEYTRUDA alone for the first-line treatment of adults with unresectable or metastatic melanoma. The dual primary endpoints are OS and PFS, as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Key secondary endpoints include ORR and DOR, both as assessed by RECIST v1.1, and safety. The study enrolled 674 patients who were randomized 1:1 to receive:

• LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle); or
• placebo via oral capsule daily plus KEYTRUDA (200 mg IV on Day 1 of each three-week cycle)

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 Melanoma

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of melanocytes, pigment producing cells.¹ The rates of melanoma have been rising over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.^1,2 In the U.S., skin cancer is one of the most common types of cancer diagnosed. Although melanoma accounts for only 1% of skin cancers, it accounts for a large majority of skin cancer deaths.¹ It is estimated there will be nearly 100,000 new cases of melanoma diagnosed and approximately 8,000 deaths resulting from the disease in the U.S. in 2023.¹ The five-year survival rates from 2012-2018 are estimated to be 71% for regional disease and 32% for distant disease.³

About LEAP-017

LEAP-017 is a randomized, open label, Phase 3 trial (ClinicalTrials.gov, NCT04776148) evaluating LENVIMA plus KEYTRUDA versus regorafenib or TAS-102, for patients with unresectable and metastatic colorectal cancer that is pMMR or not MSI-H who have received and progressed on or after, or became intolerant to, prior treatment. Patients must have been previously treated for colorectal cancer and have shown disease progression as defined by RECIST v1.1 on or after, or could not tolerate, standard treatment. The standard treatment must include all of the following agents, if approved and locally available in the country where the participant is randomized:

• Fluoropyrimidine, irinotecan and oxaliplatin;
  ・With or without an anti-vascular endothelial growth factor monoclonal antibody (bevacizumab);
  ・With anti-epidermal growth factor receptor monoclonal antibodies (cetuximab or panitumumab) for RAS (KRAS/NRAS) wild-type (WT) participants; and
• BRAF inhibitor (in combination with cetuximab +/- binimetinib) for BRAF V600E mutated metastatic colon cancer.

The primary endpoint is OS and key secondary endpoints include PFS, ORR and DOR, according to RECIST v1.1 per blinded independent central review (BICR). The study enrolled 480 patients randomized 1:1 to receive:

• LENVIMA (20 mg given orally once daily) plus KEYTRUDA (400 mg IV on Day 1 of each six-week cycle); or
• Regorafenib (160 mg given orally once daily on Days 1 through 21 of each four-week cycle; or TAS-102 (35mg/m2 given orally twice daily on Days 1 through 5 and Days 8 through 12 of each four-week cycle).

KEYTRUDA was administered for up to 18 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 colorectal cancer

Colorectal cancer can be referred to as colon cancer or rectal cancer, depending on where the cancer starts.⁴ Colorectal cancer often begins with growths on the inner lining of the colon or rectum called polyps, which can change into cancer over time.⁴  Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer-related death worldwide.⁵ It is estimated there were more than 1,880,000 new cases of colorectal cancer globally in 2020.⁵ In Japan, it is estimated there were more than 147,000 new cases of colorectal cancer diagnosed and more than 59,000 deaths from this disease in 2020.⁶ In the United States, it is estimated there will be approximately 107,000 new cases of colon cancer and approximately 46,000 new cases of rectal cancer, resulting in more than 52,000 deaths from colorectal cancer in 2023.⁷ The five-year relative survival rates in the U.S. for metastatic colon cancer and rectal cancer (stage IV) are estimated to be 13% and 17%, respectively.⁸

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 40 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 45 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 mismatch repair proficient (pMMR), as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H), 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 clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in multiple tumor types across more than 10 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) and LinkedIn (for U.S. and EMEA).

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 Twitter, 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).

¹ American Cancer Society. Key Statistics for Melanoma Skin Cancer. https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html .

²International Agency for Research on Cancer, World Health Organization. “Skin Fact Sheet.” Cancer Today, 2020.　https://gco.iarc.fr/today/data/factsheets/cancers/16-Melanoma-of-skin-fact-sheet.pdf .

³ National Cancer Institute, Surveillance, Epidemiology, and End Results Program. “Cancer Stat Facts: Melanoma of the Skin” https://seer.cancer.gov/statfacts/html/melan.html .

⁴ American Cancer Society. “What is Colorectal Cancer?” About Colorectal cancer.

https://www.cancer.org/cancer/colon-rectal-cancer/about/what-is-colorectal-cancer.html .

⁵ Cancer. Net^®. Colorectal Cancer: Statistics

https://www.cancer.net/cancer-types/colorectal-cancer/statistics .

⁶ International Agency for Research on Cancer, World Health Organization. “Japan Fact Sheet.” Cancer Today, 2020.

https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf .

⁷ American Cancer Society. Cancer Facts & Figures 2023.

https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2023/2023-cancer-facts-and-figures.pdf .

⁸ American Cancer Society. “Survival Rates for Colorectal Cancer” Early detection, Diagnosis, and Staging.

https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html .

Lifenet and Eisai Co-Develop Dementia Insurance “be”

by codm | Mar 21, 2024 | Newsletter

Supporting early detection and treatment of dementia and mild cognitive impairment (MCI)

For Print(PDF)

LIFENET INSURANCE COMPANY (Headquarters: Chiyoda Tokyo, President: Ryosuke Mori, “Lifenet”) and Eisai Co., Ltd. (Headquarters: Bunkyo Tokyo, CEO: Haruo Naito, “Eisai”) announced today that they have co-developed Dementia Insurance “be”, a dementia insurance that supports early detection and treatment of dementia and mild cognitive impairment (hereafter, “MCI”) as one of the initiatives under the capital and business alliance agreement concluded in August 2022 for collaboration in dementia and other areas.

■ Environment Surrounding Dementia

Prevalence of dementia is increasing year-by-year amid an aging population, among other factors. In Japan, it is estimated that approximately one in five people aged 65 or older will be living with dementia by 2025*¹, and it is a common disease that could affect anyone. In addition to medical and nursing care costs, dementia can also cause financial burden to family members who are responsible for nursing and other forms of care, such as transportation costs due to long distance commutes required for care and reduced income due to decreased work hours.

■ Background Behind the Development of “be”

In August 2022, Lifenet and Eisai entered into a capital and business alliance agreement to collaborate in dementia and other areas with the aim of helping reduce the burden of medical and nursing care for people living in Japan’s aging society, and have been considering new insurance products and services as a joint initiative.

For the early treatment of dementia, it is thought that detecting the disease in the stage of MCI is important. MCI is the stage just before dementia diagnosis, where cognitive function is somewhere between the healthy and dementia states. Early detection and appropriate preventative measures may prolong or restore the existing state, or reduce the progression to dementia.

Although some measures including lifestyle changes and exercise are considered effective in treating MCI, with the approval of a new pharmaceutical treatment for some types of MCI and mild dementia in 2023*², medication may also become an option for early treatment. Pharmaceutical treatment is covered by public service, but it is important to be financial prepared as a certain amount of co-payment is required, including for tests and other expenses.

In light of these circumstances, Lifenet and Eisai co-developed a dementia insurance based on the concept of early detection and treatment, by leveraging Eisai’s experience and network in drug discovery and disease awareness activities in the field of dementia, which it has built up over many years, and Lifenet’s know-how and technologies cultivated in insurance products and related services. This dementia insurance product is offered by Lifenet.

■ Overview of Dementia Insurance “be”

Dementia Insurance “be” supports the early detection and treatment of dementia, increasing treatment options by providing generous coverage from the MCI stage.

In addition, in order to detect dementia at an early stage, it is important for not only policyholders but also their family members and others around them to pay attention to their brain health and understand the differences between age-related forgetfulness and cognitive decline leading to dementia. At the same time as the launch of Dementia Insurance “be”, an official LINE account Brenavi*³ focused on Eisai’s dementia-related content will be provided to support the prevention, early detection, and aftercare of dementia through the provision of information on brain health, a search function for medical institutions, brain training games and brain-stimulating exercise content.

■ Coverage of Dementia Insurance “be”

*Summary of coverage. Details of coverage will be available on Lifenet’s website after launch (Japanese Only).

■ Newly Launched Services to Support Maintenance and Improvement of Brain Health, and Understanding on MCI/Dementia

1. Exclusive Service for Policyholders of Dementia Insurance “be”

Eisai’s brain health (brain performance) self-check tool NouKNOW^® (non-medical device) is planned to be offered to Dementia Insurance “be” policyholders as an ancillary service by the end of 2024. NouKNOW is a tool that uses a simple card test using a PC, tablet or smartphone device to perform four tests evaluating psychomotor function, attention, learning and memory, and working memory. Its purpose is not to prevent or diagnose disease, but to raise policyholders’ awareness of brain health through regular checks.

2. Services Available for Everyone

Brenavi will be launched as a service to support the maintenance and improvement of brain health and understanding of MCI and dementia. Brenavi is an official LINE account that provides information related to MCI and dementia. This service is not limited to Dementia Insurance “be” policyholders and is available to everyone.

It will introduce a wide range of brain-related information, including free brain training game Brain Workout*⁴, the exercise program Brepacise*⁴ that stimulates the brain while having fun, and Forgetfulness Consultation Navi*⁴ where users are able to search for medical institutions throughout Japan where they can have a consultation regarding forgetfulness.

*1 Source: Cabinet Office, “Annual Report on the Aging Society, Fiscal Year 2017 Edition”
*2 New treatment is indicated for patients of MCI and mild dementia due to Alzheimer’s disease
*3 Brenavi is an official LINE Account operated by Lifenet
*4 Services provided by Eisai

* The Brenavi LINE account can be added as a friend by scanning the QR code on the below. (Japanese only)

■ About Lifenet                            URL: https://ir.lifenet-seimei.co.jp/en/

Remembering the original purpose of life insurance – mutual support – LIFENET INSURANCE COMPANY was founded with the goal of offering simple, convenient and competitively priced products and services based on the highest levels of business integrity. We sell these products and services directly to customers over the Internet. We aim to be the leading company driving the growth of the online life insurance market.

■ About Eisai                                URL: https://www.eisai.com/　

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 connect with us on X, LinkedIn and Facebook.

Disclaimer: This is a summarized translation/version of the original Japanese document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Japanese document prevails.

EISAI SELECTED AS A NADESHIKO BRAND 2024 AS A LISTED COMPANY EXCELLING IN PROMOTION OF WOMEN IN THE WORKPLACE

by codm | Mar 21, 2024 | Newsletter

For Print(PDF)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been selected for the first time by the Ministry of Economy, Trade and Industry (METI) and the Tokyo Stock Exchange (TSE) as one of the Nadeshiko Brand 2024, as a listed company excelling in the promotion of women in the workplace.

The Nadeshiko Brand initiative aims to introduce certain Tokyo Stock Exchange(TSE)-listed enterprises that are outstanding in terms of encouraging women’s empowerment in the workplace as attractive stocks to investors who place emphasis on improving corporate value in the medium- and long-term, thereby further raising investors’ interest in such enterprises and accelerating the encouragement of women’s empowerment and information disclosure in outstanding enterprises. The initiative has been co-conducted by METI and TSE since FY2012.

Eisai’s Articles of Incorporation defines employees as one of the major stakeholders and specifies that Eisai endeavors to “respect human rights and diversity,” “providing full opportunities for growth in support of self-fulfillment,” and “create an employee-friendly environment” in addition to “ensuring stable employment”. In line with this, Eisai has formulated an “Integrated HR Strategy” and have been implementing human resource policies with the pillars of “well-being including employee health”, “diverse workstyle”, “employee growth”, and “organizational and business growth”, that ensure both individuals and the organization grow together.

Diversity is a source of innovation and an important approach to realize our corporate concept. Eisai has been promoting the creation of a corporate culture in which people with diverse values can play an active role regardless of nationality, gender, age, or other factors. In 2021, Eisai formulated a 10-year plan, named “Eisai Diversity & Inclusion 2021,” which includes targets for the ratio of women in management positions and the rate of men taking paternity and childcare leave, as well as action plans to achieve these targets. Eisai is planning and promoting specific and effective measures tailored to the circumstances of each office.

Moreover, in 2023 Eisai published the “Human Capital Report 2023” that focuses on its human capital initiatives and KPI linked to its human resource strategies within Japan. Eisai will continue to strengthen its global information disclosure and DE&I (Diversity, Equity & Inclusion) promotion.

Eisai is seeking to provide impact to various stakeholders by delivering new value to patients and the people in the daily living domain through the activities of our employees who are the only stakeholders that can directly contribute to our corporate concept, human health care.

*For further details on Eisai’s human capital strategy, including DE&I promotion, can be found in the annual Value Creation Report, and on the Sustainability page of the corporate website.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

EISAI INVESTS IN C2N TO SUPPORT SIMPLIFYING THE DIAGNOSIS OF EARLY ALZHEIMER’S DISEASE TO BETTER SERVE PATIENTS

by codm | Mar 6, 2024 | Newsletter

For Print (PDF)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. has decided to invest up to 15 million USD in C₂N Diagnostics LLC (Headquarters: St. Louis, Missouri, the United States “C₂N”) to support C₂N’s efforts to expand the availability, accessibility, affordability and utilization of blood-based tests for the diagnosis of Alzheimer’s disease (AD) in the U.S. This investment is in addition to the collaboration with C₂N announced in August 2022 regarding the use of blood-based assays in the diagnosis of people living with dementia in clinical practice in the U.S.

The presence of amyloid β (Aβ), a component of AD pathology, is currently confirmed using advanced diagnostic techniques such as positron emission tomography (PET) or by tests that require the collection of cerebrospinal fluid (CSF). By investing in C₂N, Eisai seeks to support efforts to advance blood-based Aβ diagnostics that are accurate and affordable, providing new options for confirming the presence of Aβ.

“The field of highly accurate blood-based diagnostics is rapidly advancing and expanding,” said Keisuke Naito, Global Alzheimer’s Disease Officer, Senior Vice President, Eisai. “Given the expense and capacity limitations of PET and CSF tests, Eisai is working to support the dementia ecosystem’s growth. The availability of more affordable and minimally invasive diagnostic tools helps support broad access for the management of Alzheimer’s disease.”

An estimated 6.7 million people in the U.S. are living with Alzheimer’s dementia.¹ Clinical symptoms alone cannot provide accurate diagnosis. Identifying patients through accurate and simple blood-based testing may lead to more efficient diagnoses, expanded treatment opportunities and reduced medical and care costs, thereby simplifying and accelerating earlier treatment, when appropriate. Importantly, blood-based tests could also support improved care for people in underserved communities and areas where access to amyloid PET and CSF testing are not a viable option.

As a pioneer in the AD field and an hhceco company, Eisai is strongly committed to supporting the development of an environment that includes the blood-based diagnosis of AD. Using multiple approaches, Eisai collaborates with several diagnostic companies and with local governments to expand the dementia ecosystem. This investment and Eisai’s collaboration with C₂N are examples of such activities, through which we seek to provide and support solutions that can help relieve the anxieties of people living with AD, their families and care partners.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

Eisai Inc. (U.S.)
Libby Holman
+ 1-201-753-1945
Libby_Holman@eisai.com

[Notes to editors]

1.  About C₂N Diagnostics, LLC

C₂N Diagnostics (“C₂N”) is a specialty diagnostics company with a vision to bring Clarity Through Innovation^®. C₂N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C₂N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health.

C₂N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C₂N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums. Over 15,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. For more information visit www.C2N.com.

1. https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf

EISAI TO PRESENT DATA ON LECANEMAB AND OTHER ALZHEIMER’S DISEASE RESEARCH AT THE AD/PD™ 2024 ANNUAL MEETING

by codm | Feb 29, 2024 | Newsletter

For Print (PDF)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the company will present the latest findings on lecanemab (generic name, U.S. brand name: LEQEMBI^®), Eisai’s anti-amyloid beta (Aβ) protofibril* antibody for the treatment of Alzheimer’s disease (AD), at the 2024 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD™) from March 5-9 in Lisbon, Portugal, and virtually. The lecanemab data and additional research findings from Eisai’s AD portfolio will be featured in 18 presentations, including ten oral presentations.

Eisai will present five oral presentations and one poster presentation on lecanemab results. From the Phase 3 Clarity AD study in subjects with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia (collectively known as early AD) with confirmed brain Aβ accumulation, presentations will include data on the effect of lecanemab treatment on tau accumulation in whole brain regions, and outcomes of long-term efficacy of lecanemab. In addition, the differences in the binding properties of multiple anti-amyloid (Aβ) antibodies to various types of Aβ and other data will be presented. Eisai will also host a symposium titled “Defining meaningful benefits to patients, caregivers, and healthcare systems in Alzheimer’s disease”.

“Lecanemab treatment of early AD in the Phase 3 Clarity AD study had less clinical decline and slower tau accumulation than placebo. ” said Michael Irizarry, M.D., Deputy Chief Clinical Officer and Senior Vice President of Clinical Research at Eisai Inc. “The earlier MCI due to AD and mild AD dementia are diagnosed and treated, the greater the opportunity for the patient to benefit. We will continue to share the importance of and rationale for early treatment with lecanemab to the scientific community.”

Eisai Symposium – Defining meaningful benefits to patients, caregivers, and healthcare systems in Alzheimer’s disease.

Eisai is sponsoring a symposium featuring three prominent clinical experts in the field of AD, Dr. Jeffrey Cummings, Dr. Robert Perneczky and Dr. Miia Kivipelto. Dr. Jeffrey Cummings will chair the symposium, and provide an overview of meaningful benefits, including clinical meaningfulness and the evolution of approaches for the clinical study of AD. Dr. Robert Perneczky will discuss how to assess meaningful benefits of treatments in development for AD. Dr. Miia Kivipelto’s presentation will provide new statistical methods to measure meaningful benefits and address various stakeholder perspectives. (Thursday, March 7, 11:10-12:50)

Eisai’s Chief Clinical Officer, Lynn Kramer, M.D., will give a plenary presentation as “Novel approaches to clinical development and the future potential of simulated placebo” on March 7 at the “Aβ TARGETING THERAPIES IN AD 1” session.

AD/PD 204 Presentations Relating to Eisai’s Key Compounds and Research

Oral Presentations

Poster Presentations

Eisai-Sponsored Symposium

Plenary Presentation

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

* Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.^{1, 2,3}

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

Eisai Europe, Ltd.
(Europe, Australia, New Zealand and Russia)
EMEA Communications Department
+44 (0) 786 601 1272
EMEA-comms@eisai.net

Eisai, Inc. (U.S.)
Libby Holman
+1-201-753-1945
Libby_Holman@eisai.com

[Notes to editors]

1. About Lecanemab
Lecanemab (brand name in the U.S.: LEQEMBI) 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 traditional approval in July, 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.

Please see full U.S. Prescribing Information.

In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) in September, 2023, to manufacture and market lecanemab as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to AD. In China, Eisai received approval for the treatment of MCI due to AD and mild AD in January 2024

LEQEMBI’s approval was 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.^4,5 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.

Eisai has also submitted applications for approval of lecanemab in 14 countries and regions, including EU, Canada and Great Britain.

Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing of lecanemab 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.

2. 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.

3. 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.

References
¹ https://www.alzforum.org/news/conference-coverage/lecanemab-sweeps-toxic-av-protofibrils-catches-eyes-trialists
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 (2022). https://doi.org/10.1007/s13311-022-01308-6. Accessed February 9, 2023
⁴ Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer’s disease at Clinical Trials on Alzheimer’s Disease (CTAD) conference. Available at: https://www.eisai.com/news/2022/news202285.html Last accessed: February 2024.
⁵ van Dyck. C, et al. Lecanemab in Early Alzheimer’s Disease. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2212948. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948

EISAI TO BOOST INITIATIVES ON GREENHOUSE GAS REDUCTION,AIMING TO ACHIEVE NET ZERO BY 2050

by codm | Feb 21, 2024 | Newsletter

PARTICIPATION IN JCI RACE TO ZERO CIRCLE AND APPROVAL FOR SBT 1.5°C TARGET

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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito “Eisai”) announced today that it has received approval to participate in the Japan Climate Initiative (JCI) Race to Zero Circle, which commits to achieve net zero* by 2050, as part of its mid- and long-term initiatives to reduce greenhouse gas (GHG) emissions. Eisai also received approval for the SBT 1.5°C target, a new GHG reduction target, by “Science Based Targets (SBT) initiatives”, as outlined below.

Investor Contacts:

Upon the establishment of the Paris Agreement at the 21^st Session of the Conference of the Parties (COP21) to the United Nations Framework Convention on Climate Change (UNFCCC) in December 2015, global common initiatives have been accelerated to the limit the global temperature rise to within 1.5°C of above pre-industrial levels (1.5°C target), and to by extension achieve net zero by 2050.

The need for immediate action to achieve the 1.5°C target was reaffirmed at the 28^th Session of the Conference of the Parties (COP28) in December 2023. Eisai set a SBT 2.0°C target (30% reduction of GHG emissions by FY2030 compared to FY2016) in FY2019, achieving the goal for three consecutive years by FY2022, accomplishing a 60% reduction of emissions compared to the baseline FY2016 level. In order to achieve Net Zero by 2050, Eisai continues to strengthen its GHG reduction initiatives though the JCI Race to Zero Circle and the newly approved SBT 1.5°C target, as well as our continued commitment to the global initiative RE100.

Eisai’s corporate concept is to give first thought to patients and the people in the daily living domain, and increase the benefits that health care provides to them as well as meet their diversified healthcare needs worldwide. To realize this human health care (hhc) concept, it is essential to ensure the sustainability of the global environment, which is the basis of its business activities.

Eisai will promote its initiatives to mitigate climate change in line with its set goals in order to support people to “live their fullest lives” through ensuring social sustainability.

*Net Zero (the SBTi definition of net-zero)

• Reducing scope 1, 2, and 3 emissions to zero or to a residual level that is consistent with reaching net-zero emissions at the global or sector level in eligible 1.5°C -aligned pathways.
• Neutralizing any residual emissions at the net-zero target year and any GHG emissions released into the atmosphere thereafter.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

[Notes to editors]
1.  About The Japan Climate Initiative (JCI)
The Japan Climate Initiative (JCI) is a network committed to forging communication and the exchange of strategies and solutions among all actors, such as Japanese companies, local governments, research institutions and NGOs, that are implementing climate actions. JCI Race to Zero Circle is an official partner of Race To Zero, a global campaign promoted by the United Nations (UN).

Please refer to JCI website for further details.

2.  About Race To Zero
Race To Zero is a global campaign rallying non-state actors – including companies, cities, regions, financial, educational, and healthcare institutions – to take rigorous and immediate action to achieve net zero by 2050 at the latest. Five criteria known as 5P’s (Pledge, Plan, Proceed, Publish and Persuade) apply to all members who join Race to Zero.

3.  About Science Based Target (SBT) initiative
SBT initiative is an international joint initiative by CDP, which is a global non-governmental organization (NGO) running an environmental information disclosure program, the UN Global Compact (UNGC), the World Wide Fund for Nature (WWF) and the World Resources Institute (WRI). SBT is a set of science-based targets for Greenhouse Gas (GHG) reduction goals, which is reviewed and approved by the SBT initiative and globally embraced as a de facto standard.

Please refer to SBT initiative website for further details.

4.  About Eisai’s Environmental Initiatives
The protection of the global environment, which is the foundation of our business activities, is not only an important, management issue for Eisai, but also has a significant impact on the lives of patients and the people in the daily living domain. It is also closely connected to Eisai’s contribution to social sustainability from a long-term perspective as stated in our Articles of Incorporation. Under “the ENW Environmental Protection Policy” and “Environmental Management Vision”, Eisai is committed to providing solutions to social issues by enhancing its environmental activities.

Please refer to our website for Eisai’s environmental commitments.