The supplemental Biologics License Application for pembrolizumab plus chemotherapy (pemetrexed plus carboplatin) has been accepted for review by the FDA for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations.
This is the first application for regulatory approval of pembrolizumab in combination with another treatment.
The application seeks accelerated approval for pembrolizumab at a fixed dose of 200 mg administered by IV every 3 weeks in combination with pemetrexed 500 mg/m2 administered as an IV infusion over 10 minutes every 3 weeks, and carboplatin AUC 5 mg/mL/min every 3 weeks for four cycles. KEYNOTE-021, Part 2, Cohort G, the pivotal cohort that forms the basis of the submission, studied 123 previously untreated patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and regardless of PD-L1 expression.
Pembrolizumab is currently approved in lung cancer for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50% or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.