Pembrolizumab, the programmed death receptor-1 (PD-1)–blocking antibody, is now approved as a first-line treatment of unresectable or metastatic melanoma, based on the results of the KEYNOTE-006 study.
This is the second approval for an advanced melanoma indication for pembrolizumab (Keytruda), according to a statement issued by Merck, the manufacturer. Pembrolizumab was first approved in 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
The FDA-approved dose is 2 mg/kg every 3 weeks.
In KEYNOTE-006, a phase III study that compared pembrolizumab to ipilimumab (Yervoy), also a PD-1–blocking antibody, in 834 patients with unresectable or metastatic melanoma with progression of disease, overall survival and progression-free survival were significantly increased among those treated with pembrolizumab, compared with ipilimumab.
The results were reported at the annual meeting of the American Association for Cancer Research in April, and published simultaneously in the New England Journal of Medicine (2015; 372:2521-32).