Eisai + Merck Inc., to collaborate on development and marketing of Lenvima as monotherapy and with Keytruda.

Eisai Co., Ltd. and Merck & Co., Inc., announced that the companies have agreed upon a strategic collaboration for the worldwide 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., will develop and commercialize Lenvima jointly, both as monotherapy and in combination with Merck & Co., Inc., anti-PD-1 therapy, Keytruda (pembrolizumab).

Eisai will book Lenvima product sales globally, as monotherapy and in combination, and Merck & Co., Inc., 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 III 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 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/II 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/Keyrtuda 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.