Keytruda recommended for approval in Europe as advanced melanoma treatment

Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion in recommending Keytruda for treating advanced melanoma.

The Committee for Medicinal Products for Human Use (CHMP)’s recommendation of Keytruda (pembrolizumab), an anti-PD1 therapy, as both first-line therapy and in previously treated patients, was based on data from more than 1,500 patients with advanced melanoma, according to a press release. The European Commission for central marketing authorization in the European Union will review the opinion.

The recommendation follows Merck’s announcement in March that pembrolizumab is the first treatment to be accepted through the United Kingdom’s new Early Access to Medicines Scheme.

Pembrolizumab monotherapy at a dose of 2 mg/kg every three weeks, the currently approved dose for advanced melanoma in the United States, was recommended by CHMP, according to the release.

“We have established a broad data set for Keytruda in the treatment of advanced melanoma, and have demonstrated improvements in progression-free survival compared to chemotherapy and survival benefits compared to ipilimumab,” Roger Dansey, therapeutic area head and senior vice president, oncology late stage development, Merck Research Laboratories, said in the release.

Three studies made up the data on which the recommendation was based. In a phase 1b study, pembrolizumab demonstrated “durable objective responses in patients with advanced melanoma,” the release stated. In a phase 2 study, pembrolizumab was shown to be superior to chemotherapy for progression-free survival in Yervoy (ipilimumab, Bristol-Myers Squibb)-refractory advanced melanoma, and in the phase 3 study, pembrolizumab displayed superiority in overall survival, progression-free survival and overall response rate compared with ipilimuab, the release stated. The study’s independent data monitoring committee had recommended the phase 3 trial had met its primary endpoints, and the trial was stopped in early March 2015 based on the recommendation, according to the release.

Adverse events reported in less than 3% of 411 patients with advanced melanoma receiving pembrolizumab treatment included pneumonitis, colitis, hepatitis, hypophysitis, nephritis and hyperthyroidism, the release stated.

Reference: www.merck.com