FDA Accepts Merck's BLA For MK-3475 In Advanced Melanoma
By Cyndi Root
Merck announced in a press release that the Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for MK-3475. The investigational anti-PD-1 antibody is for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. The FDA will review the BLA under the Accelerated Approval program and will review the application by October 28, 2014. Merck intends to submit a new drug application in Europe for advanced melanoma by the end of the year.
Dr. Roger M. Perlmutter, President of Merck Research Laboratories said, “Patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments. 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
MK-3475 was previously granted a Breakthrough Therapy designation for advanced melanoma. The investigational drug is an anti-PD-1 antibody in a new class of immune checkpoint modulators. Tumors can avoid the immune system by exploiting a mechanism in the PD-1 inhibitory checkpoint protein. MK-3475 blocks PD-1, restoring the immune system’s natural ability to target cancer cells. The agent is engaged in over seven clinical studies with different kinds of cancer including head and neck, colorectal, and bladder cancer. The broad scope of investigation is due to Merck’s Phase IB trial evaluating MK-3475 in late stage cancers.
Clinical Studies
Merck will present data from three cancer types at the annual American Society of Clinical Oncology (ASCO) Meeting, with 15 abstract presentations and six oral presentations. The focus of the presentations is on the MK-3475 development program, which uses the agent in monotherapy and in combination with other agents.
Merck expects to have 24 clinical trials underway by the end of 2014. Over 300 clinical sites will participate worldwide, seeing an estimated 6,000 patients. Monotherapy studies will include seven Phase III trials for melanoma, non-small cell lung cancer (NSCLC), advanced head and neck cancer, and advanced bladder cancer. Combination studies will include ten trials on previously mentioned cancers as well as HER2+ breast cancer and advanced renal cell carcinoma.
Along with the FDA’s BLA acceptance and priority review of MK-3475, Merck also announced a Phase 1 study of another of its investigational compounds, MK-4166. The anti-GITR agonistic antibody, MK-4166, is for the treatment of patients with advanced malignances.