Eisai Co., Ltd. and MSD (Merck) 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 MSD will develop and commercialize LENVIMA jointly, both as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). Eisai will book LENVIMA product sales globally, as monotherapy and in combination, and MSD 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.
A Phase 3 study, 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.
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.