Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA) and platinum chemotherapy for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK positive mutations.

As quoted in the press release:

This approval, the first in Europe for an anti-PD-1 therapy in combination with chemotherapy, is based on data from the pivotal Phase 3 KEYNOTE-189 trial in patients with metastatic nonsquamous NSCLC regardless of PD-L1 tumor expression status, which demonstrated a significant survival benefit for the combination of KEYTRUDA with chemotherapy as compared with standard-of-care chemotherapy alone – reducing the risk of death in these patients by half (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001).

“We are very pleased that the European Commission has approved KEYTRUDA in combination with chemotherapy based on the significant survival benefit demonstrated in the KEYNOTE-189 trial,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This approval is a first in Europe and adds to the rapidly growing role of KEYTRUDA as a foundation for the treatment of lung cancer.”

Click here to read the full press release.