OREANDA-NEWS. Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion for KEYTRUDA, 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 (EU).

“Merck is committed to bringing KEYTRUDA to people with advanced melanoma in Europe as rapidly as possible, and the positive CHMP opinion marks a significant step forward,” said Roger Dansey, therapeutic area head and senior vice president, oncology late stage development, Merck Research Laboratories. “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 a survival benefit compared to ipilimumab. We look forward to working with European health authorities to make KEYTRUDA available to patients.”

Pembrolizumab, which will be marketed under the worldwide brand name of KEYTRUDA, is one of the first of a new generation of immunotherapies that works by blocking the PD-1 pathway. KEYTRUDA was the first anti-PD-1 therapy approved in the United States and the first medicine to be accepted under the UK’s Early Access to Medicines Scheme (EAMS), which was introduced to help patients benefit from promising, innovative treatments before a European license has been granted.

Data Supporting the CHMP Positive Opinion

The positive opinion was based on data from more than 1,500 patients with advanced melanoma treated with KEYTRUDA as monotherapy in three studies – from a large Phase 1b 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 1b study to date of an anti-PD-1 antibody, KEYTRUDA demonstrated durable objective responses in patients with advanced melanoma. KEYNOTE-002, a Phase 2 study, showed KEYTRUDA was superior to chemotherapy for progression-free survival in ipilimumab refractory advanced melanoma. KEYNOTE-006, a Phase 3 study, showed KEYTRUDA 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 KEYTRUDA monotherapy at a dose of 2 mg/kg every three weeks, which is the currently approved dose for advanced melanoma in the U.S.

About Melanoma

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The incidence of melanoma has been increasing over the past four decades. In 2012, approximately 232,130 new cases were diagnosed worldwide, and the incidence in Europe was estimated to be 100,300. The five-year survival rates for advanced or metastatic melanoma (Stage IV) are estimated to be 15 to 20 percent.

About KEYTRUDA® (pembrolizumab)

KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 85 clinical trials – across more than 30 tumor types and over 14,000 patients – both as a monotherapy and in combination with other therapies.