KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) is Available for the First-Line Treatment of Adult Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

KIRKLAND, QC, and MISSISSAUGA, ON, Oct. 25, 2023 /CNW/ - Merck & Co. (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. announced today that KEYTRUDA®, an anti-PD-1 therapy, in combination with LENVIMA®, the multiple receptor tyrosine kinase inhibitor discovered by Eisai, is reimbursed under the Alberta, British Columbia, Nova Scotia, Ontario, Quebec, and Saskatchewan drug plans with respective clinical criteria and conditions for adult patients with advanced (not amenable to curative surgery or radiation) or metastatic renal cell carcinoma (RCC), with no prior systemic therapy for metastatic RCC.

This combination therapy was approved by Health Canada in 2022, based on the results from the Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which demonstrated statistically significant improvements in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) versus sunitinib.

These developments are a result of the strategic collaboration between Merck and Eisai, which includes the co-development and co-commercialization of LENVIMA® in Canada.

"We commend the decision to make KEYTRUDA® plus LENVIMA® accessible to Canadians facing late-stage kidney cancer," says Marwan Akar, President and Managing Director of Merck Canada. "This marks an important milestone for the oncology community and reminds us of the tireless pursuit of our research teams in aims to help push barriers and improve health outcomes. By joining forces with Eisai, we hope to continue accelerating discoveries and developments in the oncology landscape for Canadians."

"This collaboration brings together our shared commitment to innovation, research, and patient-centered care," says Patrick Forsythe, Country Manager, Eisai Canada. "Together, we are harnessing our collective expertise and resources to help bring advancements in oncology, which is a testament to Eisai's human health care (hhc) concept of putting patients and their families first."

About CLEAR/KEYNOTE-581
Health Canada's authorization is based on findings from CLEAR (Study 307)/KEYNOTE-581, a Phase 3 multicenter, open-label, randomized trial conducted in 1,069 patients with advanced or metastatic RCC, with clear cell component, who have not received prior systemic therapy for metastatic RCC. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression, active brain metastasis, poorly controlled hypertension, uncontrolled adrenal insufficiency, gastrointestinal malabsorption, bleeding or thrombotic disorders.

The primary efficacy outcome measure was PFS, as assessed by independent radiologic review according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Key secondary efficacy outcome measures included OS and ORR. KEYTRUDA® plus LENVIMA® demonstrated statistically significant improvements versus sunitinib in all three outcomes.

About Renal Cell Carcinoma 
Kidney cancer is the 10^th most common type of cancer in Canada, with clear cell renal cell carcinoma accounting for up to 80% of cases. Signs and symptoms often appear as the cancer grows into surrounding tissues and organs, making early detection challenging. Symptoms may include blood in the urine, pain in the back and side of the abdomen, swelling of the legs and ankles, high blood pressure, tiredness, night sweats, weight loss, reduced appetite, or fever. Kidney cancer is one of the most fatal genitourinary malignancies, with a 73% five-year survival rate, and tends to be more common in people over 50, with a higher occurrence in men. 

About KEYTRUDA®
KEYTRUDA® is an anti-PD-1 therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour 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 tumour cells and healthy cells. 

KEYTRUDA® was first approved in Canada in 2015 and currently has indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma.

About LENVIMA® (lenvatinib) 
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. The combination of LENVIMA® and everolimus showed increased anti-angiogenic and anti-tumor activity as demonstrated by decreased human endothelial cell proliferation, tube formation, and VEGF signaling in vitro and tumor volume in mouse xenograft models of human renal cell cancer greater than each drug alone.

About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit www.merck.ca and connect with us on LinkedIn and X @MerckCanada.

About Eisai
Eisai's Corporate Concept is to "give first thought to patients and the people in the daily living domain, and [to] increase the benefits that healthcare 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 X, formerly known as Twitter (for U.S. and global), and LinkedIn (for U.S. and EMEA).

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline 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).

Please see the product monograph for KEYTRUDA^® (pembrolizumab) at: https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf

Please see the product monograph for LENVIMA® (lenvatinib) at:
https://ca.eisai.com/-/media/Files/CanadaEisai/LENVIMA-Product-Monograph-EN.pdf?hash=f43eb602-ffb4-469b-910b-6253e91084bc 

Media Inquiries: MERCK: Mediacanada@merck.com; EISAI: Michele Randazzo, (551) 427-6722, Michele_Randazzo@eisai.com

Investor Contacts: MERCK: Peter Dannenbaum, (732) 594-1579, Damini Chokshi, (732) 594-1577 ; Eisai Co., Ltd.; Investor Relations: +81-(0) 3-3817-5122

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC. Used under license.
LENVIMA® is part of a global strategic oncology collaboration between Eisai and Merck.
LENVIMA® is a registered trademark of Eisai R&D Management Co., Ltd.
© 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. 

SOURCE Merck Canada Inc.