FDA accepts Merck's MK-3475 BLA for review

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-3475, Merck's investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. The FDA granted Priority Review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under the FDA's Accelerated Approval program. The FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma, the most dangerous type of skin cancer. If approved by the FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators.

Merck also announced it plans to file a Marketing Authorization Application for MK-3475 in Europe for advanced melanoma by the end of 2014.

"Patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "We are hopeful that the FDA, through their priority review of our application, will agree to make MK-3475 available to patients with advanced melanoma who have no other therapeutic options."

MK-3475 Development Ongoing in 30 Tumors, as Monotherapy and in Combination

Today, Merck highlighted progress on the advancement of the MK-3475 development program - currently ongoing in 30 tumor types as monotherapy and in combination. It is anticipated that by the end of 2014, the MK-3475 development program will grow to more than 24 clinical trials across 30 different tumor types, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide, including four new Phase 3 studies. Ongoing and planned late-stage monotherapy and combination studies include:

• Seven Phase 3 registrational trials spanning advanced melanoma (adjuvant, ipilimumab-naïve, and ipilimumab-refractory), advanced non-small cell lung cancer (NSCLC) (previously-treated and previously-untreated), advanced head & neck cancer and advanced bladder cancer; and,
• Ten combination studies, including advanced melanoma, advanced NSCLC, advanced renal cell carcinoma, HER2+ breast cancer and other solid tumors.

Merck also said today that based on encouraging preclinical data, it plans to initiate a Phase 1 dose-ranging study with its investigational anti-GITR agonistic antibody, MK-4166, in patients with advanced malignances. GITR (glucocorticoid-induced TNFR receptor) is an activating immune checkpoint receptor, which is believed to stimulate immune activity against cancer cells. This will be the second investigational immune checkpoint antibody within Merck's immuno-oncology discovery program to enter clinical development.

Dr. Perlmutter added, "Our priority is advancing breakthrough immunomodulatory molecules that reveal the ability of the immune system to eliminate cancer cells. While MK-3475 provides a firm foundation for Merck's research and development strategy in oncology, we are also advancing a broad pipeline of immune checkpoint agonists and antagonists."

MK-3475 Presentations at 2014 ASCO Annual Meeting

At the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, Merck will have more than 15 company-sponsored abstracts on MK-3475, including six oral presentations. Clinical data will be presented from studies in advanced melanoma, advanced NSCLC, as well as advanced head & neck cancer, which is the first time data for MK-3475 will be presented in this cancer type.