The U.S. FDA has accepted for review a supplemental Biologics Licence Application (sBLA) seeking the approval of Keytruda (pembrolizumab) in combination with Alimta (pemetrexed) and Paraplatin (carboplatin) for patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) without mutations in EGFR or ALK genes.
The request has received Priority Review status, which is meant to shorten the review time from 10 months to six months. The action date is set for May 10, 2017.
This application, which is the first request for regulatory approval of Keytruda in combination with another treatment, was based on data from the KEYNOTE-021 study (NCT02039674), Part 2, Cohort G, which studied 123 previously untreated patients with metastatic non-squamous NSCLC, with or without PD-L1 expression, and who had no mutations in EGFR or ALK.
In this cohort of the study, patients were randomized to receive Alimta (500 mg/m²) plus Paraplatin (5 mg/mL/min) infused intravenously every three weeks for four cycles, or Alimta and Paraplatin in combination with Keytruda (200 mg) every three weeks, on the first day of each 21-day cycle.
“Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, said in a news release.
“Keytruda in combination with chemotherapy has shown promise versus chemotherapy alone in the first-line treatment of non-squamous metastatic non-small cell lung cancer, regardless of PD-L1 levels,” he said. “If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced [NSCLC].”
Keytruda is currently approved for two other lung cancer indications: previously untreated metastatic NSCLC patients with high PD-L1 expression without EGFR or ALK mutations, and metastatic NSCLC PD-L1 expression whose disease progressed during or after platinum-based chemotherapy. In addition, patients who have EGFR or ALK mutations must have received FDA-approved therapies for those mutations to be eligible to receive Keytruda.
Keytruda is also approved for previously untreated patients with advanced melanoma and for patients with recurrent or metastatic head and neck squamous cell carcinomas.