Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-010 Trial Evaluating LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Patients With Certain Types of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

by codm | Aug 25, 2023 | Newsletter

For Print (PDF)

TOKYO and RAHWAY, N.J., August 25, 2023 – Eisai (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) today provided an update on the Phase 3 LEAP-010 trial evaluating LENVIMA^®, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus KEYTRUDA^®, the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. The primary endpoints of the study were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).

Two planned interim analyses were conducted by an independent Data Monitoring Committee (DMC) over an 11-month period. In the first analysis, LENVIMA plus KEYTRUDA showed a statistically significant improvement in PFS and ORR versus placebo plus KEYTRUDA. At the second analysis, LENVIMA plus KEYTRUDA did not demonstrate an improvement in OS compared to placebo plus KEYTRUDA, and the likelihood of reaching the protocol-specified threshold for statistical significance for OS was evaluated by Merck and Eisai and deemed to be low. Accordingly, the study will be closed, and the companies are informing investigators of this decision. The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination. A full evaluation of the data from this study, including pre-planned subgroup analyses, is ongoing. The companies will work with investigators to share the results with the scientific community.

“With the LEAP-010 trial, we aimed to explore whether this combination could improve upon options already available with KEYTRUDA-based regimens for appropriate patients with metastatic or with unresectable, recurrent HNSCC,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “Although the progression-free survival results from this study were encouraging, unfortunately the combination did not result in an overall survival benefit for patients. We will apply lessons from this trial to help continue advancing research of this combination.”

“While we were initially encouraged to see that LENVIMA plus KEYTRUDA met two of its three primary endpoints at an earlier interim analysis, unfortunately the combination did not meet the threshold for the third primary endpoint of overall survival.” said Corina Dutcus, M.D., Senior Vice President, Global Clinical Development, Oncology at Eisai Inc. “Our clinical program is designed to help accelerate our efforts to tackle difficult-to-treat, advanced cancers, and while the outcome may not always be what we anticipate, we know that this is part of clinical development, and we remain committed to scientific exploration in pursuit of improving care for patients.”

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, non-small cell lung cancer, RCC, head and neck cancer, gastric cancer and esophageal cancer across multiple clinical trials. KEYTRUDA is currently approved as monotherapy and in combination regimens for appropriate patients with metastatic or with unresectable, recurrent HNSCC in the U.S., Europe, China, Japan and other countries around the world.

Results from the LEAP-010 trial do not affect the current approved indications for LENVIMA plus KEYTRUDA or other ongoing trials from the LEAP clinical program, including the ongoing LEAP-009 trial, evaluating LENVIMA in combination with KEYTRUDA versus chemotherapy in people living with recurrent or metastatic HNSCC who progressed after platinum therapy and immunotherapy.

Media Contacts:

About LEAP-010
LEAP-010 is a randomized, placebo-controlled, double-blinded, Phase 3 trial (ClinicalTrials.gov, NCT04199104) evaluating LENVIMA plus KEYTRUDA versus KEYTRUDA monotherapy as a first-line treatment for patients with recurrent or metastatic HNSCC whose tumors express PD-L1. The trial’s three primary endpoints are OS, PFS and ORR. PFS and ORR were assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors Version (RECIST) v1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The study enrolled an estimated 511 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 (orally once daily) plus KEYTRUDA (200 mg IV on Day 1 of each three-week cycle).

I both arms, 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 head and neck cancer
Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth.¹ Most head and neck cancers are squamous cell carcinomas that begin in the flat, squamous cells that make up the thin surface layer of the structures in the head and neck.¹ Two substances that greatly increase the risk of developing head and neck cancer are tobacco and alcohol.¹ Worldwide, it is estimated there were more than 930,000 new cases of head and neck cancer diagnosed and over 465,000 deaths from the disease in 2020.² In the U.S., it is estimated there will be more than 66,000 new cases of head and neck cancer diagnosed and more than 15,000 deaths from the disease in 2023.³

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
(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 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, 100 mg
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 of 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 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) 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 Cancer Net. Website, “introduction.” Head and Neck Cancer.
https://www.cancer.net/cancer-types/head-and-neck-cancer/introduction .
² International Agency for Research on Cancer, World Health Organization. Cancer Today, 2020.
Cancer Today (iarc.fr) .
³ Cancer Net. Website, “statistics.” Head and Neck Cancer.
https://www.cancer.net/cancer-types/head-and-neck-cancer/statistics

EISAI LISTED FOR 22ND CONSECTUTIVE YEAR IN FTSE4GOOD INDEX SERIES, AN INDEX FOR SOCIALLY RESPONSIBLE INVESTMENT

by codm | Aug 4, 2023 | Newsletter

For Print (PDF)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been included in the FTSE4Good Index Series for the 22^nd consecutive year since its initial inclusion in 2002. The FTSE4Good Index Series is a global index series for socially responsible investment.

The FTSE4Good Index Series was developed by FTSE Russell to promote investment in companies that meet global environmental, social and governance (ESG) standards. Eisai received particularly high scores in “Corporate Governance”, “Anti-Corruption”, “Tax Transparency”, “Labor Standards” and “Customer Responsibility”, among others. As of the end of June 2023, 1,121 companies worldwide and 250 Japanese companies were included in the FTSE4Good Developed Index Series.

Currently, in addition to the MSCI ESG Leaders Indexes, another global ESG investment index, Eisai is also listed in the FTSE Blossom Japan Index, the FTSE Blossom Japan Sector Relative Index, the MSCI Japan ESG Select Leaders Index, the MSCI Japan Empowering Women Index (WIN) and the S&P/JPX Carbon Efficient Index, which are ESG investment indices for Japanese stocks adopted by the Government Pension Investment Fund (GPIF).

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 to them, as well as address diverse healthcare needs worldwide. By strengthening its ESG initiatives and increasing non-financial value, Eisai is striving to sustainably enhance corporate value based on this concept.

For more information on our ESG initiatives, please visit https://www.eisai.com/sustainability/index.html.
Also, we post and share ESG-related information on Twitter, LinkedIn and Facebook.

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

[Notes to editors]
1.  About the ESG Investment Indices in which Eisai are listed
MSCI EDG Leaders Indexes
A comprehensive ESG index developed by US-based MSCI, Inc., consisting of companies with high ESG ratings.
(https://www.msci.com/msci-esg-leaders-indexes)

FTSE Blossom Japan Index
A comprehensive ESG index of Japanese companies, using the evaluation scheme of the FTSE4Good Japan Index developed by FTSE Russell in the U.K., with stocks with high absolute ESG ratings neutralized in terms of industry weighting.
(https://www.ftserussell.com/products/indices/blossom-japan)

FTSE Blossom Japan Sector Relative Index
A newly designed index for 2022 that is based on FTSE Russell’s ESG assessment and also evaluates the management attitude of companies toward climate change risks and opportunities.
(https://www.ftserussell.com/products/indices/blossom-japan)

MSCI Japan ESG Select Leaders Index
A comprehensive ESG index based on MSCI’s ESG research, incorporating stocks with relatively superior ESG ratings within their industry.
(https://www.msci.com/msci-japan-esg-select-leaders-index-jp) (In Japanese only)

MSCI Japan Empowering Women Index (WIN)
An index composed by calculating a multidimensional gender diversity score based on female employment data disclosed by the Law for the Promotion of Women’s Activity, selecting companies with high scores from each industry sector.
(https://www.msci.com/our-solutions/indexes/japan-empowering-women-select-index)

S&P/JPX Carbon Efficient Index
An index developed by S&P Dow Jones Indexes in the U.S. based on carbon emissions data from Trucost, a pioneer in environmental assessment.
(https://www.jpx.co.jp/english/markets/indices/carbon-efficient/

ORGANIZATIONAL REFORM AND CHANGES OF CORPORATE OFFICERS

by codm | Aug 1, 2023 | Newsletter

For Print (PDF)

<Changes of Corporate Officers, effective August 1, 2023>

Reorganization of Deep Human Biology Learning (DHBL)
1.  Integration of Alzheimer’s Disease and Brain Health (ADBH) Clinical Development Functions
To maximize the value of launched products and accelerate the development of new drugs that will lead future growth of Eisai, and promote the efficiency of clinical research and development, the clinical functions of ADBH will be integrated into DHBL. Under the Chief Scientific Officer, a Chief Clinical Officer, a Neurology Clinical Lead, an Oncology Clinical Lead, and a Chief Clinical Science & Operations Officer will be appointed to ensure a smooth transition to the new structure of DHBL.

The Medical Affairs function of ADBH will be moved directly under the Chief Scientific Officer, and the Value & Access and Global Marketing functions will be placed directly under the Global Alzheimer’s Disease Officer.

2.  Reorganization of Clinical Development function (Clinical Evidence Generation Fulfillment)
Clinical Evidence Generation (CEG) Fulfillment, which is the function responsible for proving DHBL drug discovery concepts in clinical trials and obtaining regulatory approval, will be reorganized into the Clinical Development function, which is responsible for Clinical Research, Global Regulatory, etc., and the Clinical Science & Operations function, which consolidates biostatistical analysis, data science, clinical operations, etc. A Chief Clinical Science & Operations Officer will be appointed to oversee the common operational functions of clinical research and development in the Clinical Science and Operations function.

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

Eisai Presents Latest Analysis of Lecanemab’s Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer’s Association International Conference (AAIC) 2023

by codm | Jul 20, 2023 | Newsletter

Further Phase 3 analysis shows benefits of lecanemab on both amyloid-beta and tau, two underlying pathological hallmarks of Alzheimer’s disease

New data on subcutaneous formulation shows promising PK /PD data modeling on efficacy and safety, representing a potential new option for administering therapy

For Print (PDF)

TOKYO and CAMBRIDGE, Mass., July 20, 2023 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the results of a detailed analysis of the Phase 3 Clarity AD study demonstrated that lecanemab-irmb (generic name, U.S. brand name: LEQEMBI^®) treatment showed reductions in amyloid-beta (Aβ) pathology and downstream biomarker changes. This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer’s Association International Conference (AAIC) 2023. The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer’s disease (AD) on July 6, 2023.

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897). Lecanemab met the primary endpoint (change from baseline at 18 months on the global cognitive and functional scale, Clinical Dementia Rating-Sum of Boxes [CDR-SB]) and all key secondary endpoints with statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.

Lecanemab: Amyloid Reduction and Evidence of Downstream Biomarker Modification

In addition to the key secondary endpoint of lecanemab’s effect on amyloid accumulation in the brain as measured by amyloid positron emission tomography (PET), the Clarity AD study also measured multiple A/T/N+ (amyloid, tau, neurodegeneration) biomarkers involved in the pathophysiology of AD, such as amyloid (Aβ1-42 in CSF, Aβ42/40 ratio in plasma), tau (p-Tau181 in cerebral spinal fluid [CSF] and plasma), neurodegeneration (total tau [t-tau] in CSF and neurofilament light [NfL] in CSF and plasma), astrocyte activation (plasma GFAP: glial fibrillary acidic protein) and synaptic dysfunction (neurogranin in CSF).

An increase in plasma Aβ42/40 ratio was observed with lecanemab compared to placebo (adjusted mean change from baseline of lecanemab: 0.008, placebo: 0.001, p<0.0001). A reduction in plasma p-Tau181 was observed with lecanemab compared to placebo (adjusted mean change from baseline of lecanemab: -0.575 pg/mL, placebo: 0.201 pg/mL, p<0.0001). The other biomarkers also improved after treatment with lecanemab. These outcomes suggested lecanemab impacts A/T/N+ biomarkers involved in the AD pathophysiology and exerts biological effects that demonstrate slowing of disease progression.

Baseline characteristics and initial results were presented from the tau PET substudy of Clarity AD. Lecanemab administration slowed the accumulation of tau pathology in the temporal lobe. Additionally, lecanemab administration showed a clinical effect in the overall population of the tau PET substudy, and a large effect size was observed in the low tau population* defined in this presentation, which represents the early phase of AD.

Subcutaneous (SC) Lecanemab is Predicted to Achieve Comparable Efficacy and Improved Safety Compared to Lecanemab IV in Early AD
In an exposure/bioavailability and modeling study comparing intravenous (IV) and subcutaneous (SC) dosing of lecanemab, the bioavailability of SC dosing of lecanemab was shown to be approximately 50% of that of IV dosing. Further analysis using the PK/PD model showed that a fixed lecanemab SC dose of 720 mg administered weekly may potentially result in comparable exposure (area under the curve [AUC]) and efficacy as measured by reduction in amyloid PET SUVr to 10 mg/kg IV dose administered bi-weekly. Models developed with data following IV administration show that amyloid-related imaging abnormalities with edema/effusion (ARIA-E) are related to concentrations of lecanemab in the blood, with maximum blood concentrations being the best predictor of ARIA-E. Because SC dosing will have lower maximum blood concentrations than IV dosing, SC dosing is predicted to have a lower incidence of ARIA-E, if the relationship is the same for SC dosing.

The presentation materials of this release will be posted on the investors section of the Eisai Co., Ltd. website at 19:30 on July 20 in the U.S EDT (8:30 on July 21 in Japan time).

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.

* Using the MK6240 tau PET probe, tau accumulation in the brain was defined as low tau accumulation group (MK6240 cutoff value <1.06, 141 subjects), intermediate accumulation group (MK6240 cutoff value between 1.06 and 2.91, 191 subjects), and high accumulation group (MK6240 cutoff value >2.91, 10 subjects).

Please see full Prescribing Information for LEQEMBI, including Boxed WARNING.

Media Contacts:

Investor Contacts:

Notes to Editors

1. About LEQEMBI^® (lecanemab-irmb)
LEQEMBI^® (lecanemab-irmb) 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. 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.

Eisai has also submitted applications for approval of lecanemab in Japan, EU, China, Canada, Great Britain and South Korea. In Japan and China, 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 OLE.

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.

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.

4. 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 http://www.eisai.com/ (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter, LinkedIn and Facebook.

5. 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 about 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; 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 speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements.

EISAI TO PRESENT THE LATEST ALZHEIMER’S DISEASE PIPELINE AND RESEARCH, INCLUDING LECANEMAB AND ANTI-MTBR TAU ANTIBODY E2814, AT THE ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2023

by codm | Jul 12, 2023 | Newsletter

For Print (PDF)

Eisai Co. Ltd (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company will present the latest findings on its Alzheimer’s disease (AD) pipeline and research, including Eisai’s anti-amyloid beta (Aβ) protofibril* antibody for the treatment of Alzheimer’s disease (AD), lecanemab (generic name, U.S. brand name: LEQEMBI^®), and the company’s investigational anti-MTBR** tau antibody, E2814, at the Alzheimer’s Association International Conference (AAIC). The conference will be held in Amsterdam, the Netherlands and virtually from July 16 to 20, 2023. Eisai will present data and research in eight oral and 19 poster presentations at the meeting. Two of the AAIC oral presentations will be presented as posters at the Alzheimer’s Disease Imaging Consortium (AIC), which will be held at the same venue as AAIC on July 15.

“At AAIC 2023 Eisai will present the latest data on lecanemab, an anti-Aβ protofibril antibody, that recently received traditional approval in the U.S. for patients with mild cognitive impairment (MCI) due to AD and mild AD. Leqembi was studied in a broad population, which included a mix of racial and ethnic groups and patients with common comorbid conditions and concomitant medications.” Additionally, Eisai will present important new data on E2814, an anti-MTBR tau antibody, which is currently in Phase II/III clinical trials with the Dominantly Inherited Alzheimer’s Network Trials Unit at Washington University St. Louis,” said Michael Irizarry, M.D., Deputy Chief Clinical Officer and Senior Vice President of Clinical Research, Alzheimer’s Disease and Brain Health, Eisai Inc. “As part of Eisai’s commitment to transparency and our human health care (hhc) and ecosystem mission, we will continue to present and publish data and information about our AD pipeline and research.”

Key Eisai AAIC Presentations

•  Amyloid Reduction and Evidence of Downstream Biomarker Modification Presentation of results  of Aβ, tau, neurodegeneration, gliosis, and imaging biomarkers in the Phase III Clarity AD study of lecanemab (#80907)
• Drug Development in the Era of Anti-Amyloid Therapies Discussion of considerations in the development of new drugs for AD and rational drug combinations based on pathophysiology (#70444)
• Subcutaneous Lecanemab is Predicted to Achieve Comparable Efficacy and Improved Safety Compared to Lecanemab IV in Early Alzheimer’s Disease Presentation and discussion of results from studies to date on a subcutaneous formulation of lecanemab under development to potentially improve convenience and safety profile for patients (#82852)
• E2814: An Anti-Tau Therapy Engages its CNS Target and Affects the Downstream Tangle-Specific Biomarker MTBR-tau243 in Dominantly Inherited Alzheimer’s Disease Report on the safety, pharmacokinetics, and biomarkers of anti-MTBR tau antibody E2814 in clinical trials in healthy adults and dominant inherited AD patients (#82771)

■ Eisai Oral Presentations

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

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

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

** MTBR: microtubule binding region

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. doi: 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. doi: 10.1007/s13311-022-01308-6.

CHANGES OF CORPORATE OFFICERS

by codm | Jul 11, 2023 | Newsletter

For Print (PDF)

<Changes of Corporate Officers, effective July 10, 2023>

* Ivan Cheung, currently Senior Vice President, Global Alzheimer’s Disease Officer, President, Americas Region and Chairman & CEO, Eisai Inc., will retire as of July 31, 2023.

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