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PD-1 blockade therapy with the anti-programmed-death-receptor-1 antibody pembrolizumab has shown promise for patients with advanced melanoma in prior phase II and III KEYNOTE trials (NEJM JW Derm Sep 2014 and Lancet 2014; 384:1109, and N Engl J Med 2013; 369:134).
To further assess the potential tumor response and survival benefit of pembrolizumab in this setting, investigators conducted an industry-sponsored, international, multicohort, open-label study (KEYNOTE-001) involving 655 patients with advanced melanoma (including 347 not included in the prior reports). Of all patients, 342 (52%) had previously received ipilimumab, 313 (48%) were ipilimumab-naive, and 152 (23%) were completely treatment-naive. Of 155 (24%) who had tumors with BRAF …