European Commission approves Keytruda for treating advanced melanoma

Source: Healio.com/dermatology, July 2015

Merck announced that the European Commission has approved Keytruda for treating unresectable or metastatic melanoma in adults, according to a press release.

The approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, was based off data from three clinical studies conducted in more than 1,500 patients with advanced melanoma, according to the release. The European Commission regulatory approval was based on phase 3 data showing statistically higher survival benefit with pembrolizumab treatment compared with Yervoy (ipilimumab, Bristol-Myers Squibb), the release stated.

Pembrolizumab was approved in a dose of 2 mg/kg every 3 weeks for all 28 European Union member states, according to the release.

“We believe that the broad data set supporting this approval helps illustrate the significant potential of Keytruda to treat advanced melanoma, a devastating disease,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in the press release.

The three studies evaluated efficacy and safety of pembrolizumab, including prognostic factors, tumor characteristics and BRAF mutational status, according to the release.

A phase 1b trial, KEYNOTE-001, was a single-arm, open label study of pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks given to patients with advanced melanoma who were previously treated with ipilimumab, and if BRAF V600 mutation-positive, a BRAF or MEK inhibitor, and patients who were ipilimumab-naïve, according to the release.

KEYNOTE-002 was a phase 2 randomized trial of pembrolizumab at 2 mg/kg every 3 weeks or 10 mg/kg every 3 weeks compared with chemotherapy as treatment for 540 patients who had previously been treated with ipilimumab, and a BRAF and MEK inhibitor if BRAF V600 mutation-positive.

In the phase-3 KEYNOTE-006 study, 834 patients with advanced melanoma received pembrolizumab every 2 to 3 weeks or ipilimumab, with a planned interim analysis of co-primary endpoints reporting progression-free survival and overall survival as superior in the pembrolizumab-treated patients compared to ipilimumab-treated cohort, the release stated.

Combined data from the KEYNOTE-001 AND KEYNOTE-0002 studies were used to support safety of pembrolizumab, with diarrhea, nausea, pruritus, rash and fatigue the most common adverse reactions reported, according to the release.

The FDA announced the accelerated approval of pembrolizumab for patients with advanced or unresectable melanoma following progression with prior therapies in September 2014.