Merck & Co. has announced that the U.S. Food and Drug Administration (FDA) has given KEYTRUDA® (pembrolizumab) an approved acceleration at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
KEYTRUDA is an anti-PD-1 (programmed death receptor-1) therapy, targeting a family of receptors/ligands expressed both in immune cells and tumors responsible for tumor cell evasion from immune-mediated responses. It is the first therapy of its kind to be approved in the United States, and it has received the FDAs Breakthrough Therapy designation for advanced melanoma, a designation attributed based on the first results of the ongoing multi-center, open-label, randomized, dose-comparative clinical study KEYNOTE-001, a Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease.
In this clinical study, a group of 173 patients were randomized to receive either a 2mg/kg or 10mg/kg dose of KEYTRUDA every 3 weeks until unacceptable toxicity or disease progression.
Researchers observed that the overall response rate was 24%, with one complete response and 20 partial responses. Furthermore, 86% of patients with objective responses had ongoing responses with durations ranging from 1.4+ to 8.5+ months.
“KEYTRUDA embodies Merck’s unwavering commitment to pursue breakthrough science to help people who are facing the most challenging diseases. We are grateful to the people with advanced melanoma who participated in our trials, and the scientific and medical community for the shared effort that has led to the accelerated approval of KEYTRUDA,” Kenneth C. Frazier, chairman and chief executive officer, Merck said in a company’s press release.
“The accelerated FDA approval of KEYTRUDA is a meaningful development for patients with advanced melanoma. Our new ability to target the PD-1 pathway with KEYTRUDA is a very exciting step in the immunotherapy field,” Dr. Omid Hamid, Director of the Melanoma Center at The Angeles Clinic and Research Institute, and a principal investigator for the pembrolizumab melanoma clinical program added.
Merck is currently developing Phase 2 and 3 clinical studies in advanced melanoma and plans to make KEYTRUDA commercially available in a very near future.