Eisai Co. LTd. of Japan and New Jersey-based Merck & Co., Inc., are working together in a strategic partnership for the global co-development and co-commercialization of LENVIMA (lenvatinib mesylate), an orally available tyrosine kinase inhibitor discovered by Eisai.
Under the agreement, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. will develop and commercialize LENVIMA jointly, both as monotherapy and in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).
Eisai will book LENVIMA product sales globally, as monotherapy and in combination, and Merck & Co., Inc., Kenilworth, N.J., U.S.A. and Eisai will share gross profits equally. LENVIMA is currently approved as monotherapy for use in the treatment of thyroid cancer, as well as in combination with everolimus for the treatment of patients with renal cell carcinoma (RCC) who have failed previous therapy. Applications for regulatory approval of LENVIMA monotherapy for the treatment of hepatocellular carcinoma have been submitted in Japan, the United States, Europe, China and other countries.
A Phase 3 study (Study 307), sponsored by Eisai, is ongoing to evaluate separate combinations of LENVIMA with KEYTRUDA (pembrolizumab) or LENVIMA with everolimus versus chemotherapy alone for the treatment of RCC. In January 2018, the companies announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the LENVIMA/KEYTRUDA combination in advanced and/or metastatic RCC. This was based on interim results from an ongoing Phase 1b/2 trial (Study 111/KEYNOTE-146), evaluating the combination in select solid tumors (including RCC and endometrial cancer), which provided evidence for synergistic effects on the observed overall response rate, regardless of treatment experience or PD-L1 tumor expression.
Per the agreement, the companies will also jointly initiate new clinical studies evaluating the LENVIMA/KEYTRUDA combination to support 11 potential indications in six types of cancer (endometrial cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck cancer, bladder cancer and melanoma), as well as a basket trial targeting multiple cancer types.
"Aiming to maximize the potential of LENVIMA and expedite the creation of innovative treatments in this age of "Cancer Evolution," we have entered into this collaboration with Merck who developed the anti-PD-1 antibody KEYTRUDA," commented Haruo Naito, Representative Corporate Officer and CEO of Eisai Co., Ltd. "By providing new treatment options including for refractory cancers with no hopes for a cure to date, we are striving to further contribute to increasing the benefits provided to patients and their families."
"Together with Eisai, we aim to maximize the value of LENVIMA for its current indications while jointly pursuing additional approvals in combination with KEYTRUDA across a wide range of cancers," said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. "There is strong scientific evidence supporting synergistic effects of KEYTRUDA when used in combination with LENVIMA, and the companies have already received Breakthrough Therapy Designation from the U.S. FDA for the KEYTRUDA/LENVIMA combination in renal cell carcinoma. Through this collaboration, we will both broaden our oncology portfolio and have the opportunity to help even more cancer patients around the world."
Gross profits from LENVIMA product sales globally will be shared equally by Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A.. Expenses incurred during co-development, including for studies evaluating LENVIMA as monotherapy, will be shared equally by the two companies. Under the agreement, Merck & Co., Inc., Kenilworth, N.J., U.S.A. will pay Eisai an upfront payment of $300 million U.S. dollars and up to $650 million U.S. dollars for certain option rights through 2020 (Eisai's financial year: fiscal year ended March 2021), as well as $450 million U.S. dollars as reimbursement for research and development expenses. In addition, Eisai is eligible to receive up to $385 million U.S. dollars associated with the achievement of certain clinical and regulatory milestones and a maximum of up to $3.97 billion U.S. dollars for the achievement of milestones associated with sales of LENVIMA. Assuming the achievement of all development and commercial goals for all indications, the total amount of upfront, option and regulatory and sales milestone payments has the potential to reach up to $5.76 billion U.S. dollars.