The FDA granted priority review designation to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with chemotherapy as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression.
The agency set a target action date of Oct. 30.
Pembrolizumab (Keytruda, Merck) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
The agent already is approved in the United States for treatment of certain patients with NSCLC, melanoma, head and neck cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric or gastroesophageal junction adenocarcinoma, unresectable or metastatic microsatellite instability-high or mismatch repair-deficient cancers, and cervical cancer.
The FDA based the new priority review designation on results from the KEYNOTE-407 trial, which included 560 patients with metastatic squamous NSCLC who received no prior systemic therapy for advanced disease.
The double-blind, placebo-controlled trial compared first-line pembrolizumab in combination with chemotherapy — wither carboplatin-paclitaxel or nab-paclitaxel — with chemotherapy alone. OS and PFS served as dual primary endpoints.
As HemOnc Today previously reported, topline results showed the combination improved OS and PFS. The combination also appeared associated with a higher overall response rate, a secondary endpoint.
Investigators presented full results from the study at this year’s ASCO Annual Meeting.
“Keytruda has already been established as an important treatment option for NSCLC in the first-line setting and, with our broad development program in lung cancer, we are committed to improving survival for as many patients as we can,” Roy Baynes, MD, PhD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a company-issued press release. “We are pleased that our application for squamous cell carcinoma – a historically challenging-to-treat disease – is under priority review with the FDA.”