Pembrolizumab Now Approved for First-Line Treatment of Lung Cancer in Europe and the US

Merck has announced that its programmed death-1 (PD-1) inhibitor, pembrolizumab (Keytruda), has been given the green light by the European Commission for the first-line treatment of a select population of adult patients with metastatic non-small cell lung cancer (NSCLC).

Patients with tumors that harbor a high expression of the programmed death ligand-1 receptor, without mutations in EGFR or ALK, will qualify to receive pembrolizumab instead of standard-of-care chemotherapy.

The approval follows a review of phase 3 data from the KEYNOTE-024 trial, which showed that 80% of patients on pembrolizumab were alive 6 months following treatment initiation, compared with 72% on chemotherapy. Patients on pembrolizumab also had a higher overall response rate and duration of response compared with chemotherapy. The median progression-free survival with the PD-1 inhibitor was 10.3, compared with 6 months for patients receiving chemotherapy.

“The approval of Keytruda as a first treatment instead of chemotherapy for patients who express high levels of PD-L1 has the potential to transform the way metastatic non-small cell lung cancer is treated,” Roy Banes, MD, senior vice president, head of clinical development, and chief medical officer, Merck Research Laboratories, said in a statement. “We are committed to ensuring that patients in Europe—who are in need of new treatment options—are able to quickly gain access to Keytruda.”

Pembrolizumab was approved in the United States for the same indication in October 2016.

Nivolumab, a PD-1 inhibitor developed by Bristol-Myers Squibb, and a major competitor for pembrolizumab, lagged behind in the NSCLC race following disappointing phase 3 results.