Merck's Pembrolizumab Receives Approval for Expanded Indications

Based on results submitted from the Keynote-006 trial, the FDA has expanded the use of the programmed death receptor-1 (PD-1) inhibitor pembrolizumab (Keytruda) as first-line treatment for patients with unresectable or metastatic melanoma.

Phase 3 results from KEYNOTE-006 in patients with unresectable or metastatic melanoma who were treated with pembrolizumab found superior overall survival compared with those treated with ipilimumab. In this study supporting the first-line approval, patients who were administered pembrolizumab at 10 mg/kg every 2 weeks demonstrated a 37% reduction in the risk of death and those given pembrolizumab 10 mg/kg every 3 weeks demonstrated a 31% reduction in the risk of death, both compared with ipilimumab (hazard ratio [HR], 0.63 [95% CI, 0.47, 0.83; P <.001] and HR, 0.69 [95% CI: 0.52, 0.90; P = .004], respectively).

Immune-associated adverse events that were reported included pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

Roger M. Perlmutter, MD, PhD, president of Merck, said in a statement, “Today’s news is another exciting milestone for KEYTRUDA and for patients with this disease. Data supporting the approval emerged from a large and diverse patient population, including patients with very advanced disease and patients whose tumors carried BRAF mutations, thus demonstrating both the breadth of our clinical development program for KEYTRUDA, and the potential of KEYTRUDA to extend the lives of those afflicted with this grievous malignancy.”