FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Adult and Pediatric Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma, a Rare Form of Skin Cancer

December 19, 2018

On December 19, 2018, Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the results of the Cancer Immunotherapy Trials Network (CITN)’s CITN-09/KEYNOTE-017 trial. In this Phase 2 trial of 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease, KEYTRUDA monotherapy demonstrated an objective response rate of 56 percent (95% CI, 41-70), with a complete response rate of 24 percent (95% CI, 13-38) and a partial response rate of 32 percent (95% CI, 20-47). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

“The CITN-09/KEYNOTE-017 trial demonstrates that first-line treatment with anti-PD1 therapy provides a meaningful advance for Merkel cell carcinoma patients who have historically had a poor long-term prognosis,” said Dr. Paul Nghiem, lead investigator, professor of dermatology at the University of Washington School of Medicine in Seattle and affiliate investigator at Fred Hutchinson Cancer Research Center. “A few years ago, patients with Merkel cell carcinoma did not have treatment options beyond chemotherapy. As a practicing physician I am pleased that this approval provides another option for patients facing this rare and challenging disease.”

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