Merck begins rolling submission of biologics license application for MK-3475 in advanced melanoma

Merck has begun a rolling submission to the FDA of a biologics license application for its investigational PD-1 immunotherapy for patients with advanced melanoma who had previously been treated with ipilimumab.

“Our MK-3475 is a novel immunomodulatory molecule that holds promise for patients with advanced malignancy who now have limited treatment options,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. “Initiation of this rolling submission represents an important milestone in the MK-3475 clinical development program for patients suffering from malignant melanoma.”

MK-3475 is a “highly selective anti-PD-1 immunotherapy designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein,” according to the release.

Immune system T-cells that target cancer are activated when MK-3475 blocks PD-1.

Three clinical trials for advanced melanoma, including a phase 3 trial of MK-3475 compared with ipilimumab in ipilimumab-naive patients are being conducted, the release said. A phase 1b trial and phase 2 trial are comparing two doses of MK-3475 with chemotherapy in patients whose advanced melanoma has progressed since previous therapies.

The FDA granted breakthrough therapy designation to MK-3475 in 2013 for advanced melanoma.

Under a rolling submission, completed portions of an application can be submitted and reviewed by the FDA, according to the release. Merck expects to complete the application in the first half of the year.

Currently, 10 clinical trials investigating MK-3475 in more than 4,000 patients with cancers, including bladder, colorectal, gastric, head and neck, melanoma, nonsmall cell lung, renal, triple negative breast and hematological malignances, are being conducted, according to the release.