Merck & Co., Inc. (NYSE:MRK) and Eisai Co., popularly known as MSD outside the U.S. and Canada, reported that the firms have finalized a strategic collaboration for the global co-commercialization and co-development of LENVIMA®. Under the agreement, Merck and Eisai will commercialize and develop LENVIMA jointly, both together with Merck’s KEYTRUDA® and also as monotherapy.
Eisai will record LENVIMA product sales worldwide, in combination and as monotherapy, and Eisai and Merck will distribute gross profits equally. LENVIMA is presently permitted as monotherapy for application in the treatment of thyroid cancer, and together with everolimus for the cure of people with renal cell carcinoma who have failed earlier treatment. Applications for regulatory permission of LENVIMA monotherapy targeting hepatocellular carcinoma have been filed in Japan, the U.S., China, Europe and other nations.
A Phase III trial, supported by Eisai, is ongoing to assess distinct combinations of LENVIMA with KEYTRUDA or LENVIMA with everolimus as compared to chemotherapy alone for the cure of RCC. In January 2018, the firms reported that the U.S. FDA granted Breakthrough Therapy Status for the LENVIMA/KEYTRUDA combination in metastatic and/or advanced RCC. This came on interim data from an ongoing Phase 1b/2 study, assessing the combination in selected solid tumors including endometrial cancer and RCC, which offered evidence for synergistic impacts on the observed ORR, irrespective of PD-L1 tumor expression or treatment experience.
As per the deal, Merck and Eisai will also jointly commence new clinical trials assessing the LENVIMA/KEYTRUDA combination to advance 11 prospective indications in six different types of cancer and a basket study targeting several cancer types.
Haruo Naito, the CEO of Eisai, expressed that aiming to enhance the potential of LENVIMA and advance the creation of unique treatments in this era of “Cancer Evolution,” they have entered into this association with Merck who advanced KEYTRUDA.