CHMP recommends approval of Keytruda (pembrolizumab) for advanced melanoma- Merck Inc

The CHMP of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda (pembrolizumab), from Merck Inc., for the treatment of advanced (unresectable or metastatic) melanoma as both first-line therapy and in previously-treated patients. The CHMP positive opinion for pembrolizumab, which is based on data in more than 1,500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union.

The positive opinion was based on data from more than 1,500 patients with advanced melanoma treated with pembrolizumab as monotherapy in three studies – from a large Phase Ib study, KEYNOTE-001; from a randomized, controlled study, KEYNOTE-002; and an interim analysis from a second, randomized controlled study, KEYNOTE-006. In KEYNOTE-001, the largest Phase Ib study to date of an anti-PD-1 antibody, pembrolizumab demonstrated durable objective responses in patients with advanced melanoma. KEYNOTE-002, a Phase II study, showed pembrolizumab was superior to chemotherapy for progression-free survival in ipilimumab refractory advanced melanoma.

KEYNOTE-006, a Phase III study, showed pembrolizumab was superior to ipilimumab for overall survival, progression-free survival, and overall response rate. The trial was stopped early in March 2015 based on the recommendation of the study’s independent Data Monitoring Committee as it had met its two primary endpoints. The CHMP recommended approval of pembrolizumab monotherapy at a dose of 2 mg/kg every three weeks, which is the currently approved dose for advanced melanoma in the U.S.