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news.The US Food and Drug Administration (FDA) has accepted for review Merck's supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) 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.
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This is the first application for regulatory approval of KEYTRUDA in combination with another treatment. The FDA granted Priority Review with a PDUFA, or target action, date of May 10, 2017. The sBLA will be reviewed under the FDA’s Accelerated Approval program.
Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, said: “Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer.
“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. If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non-small cell lung cancer.”
The application seeks accelerated approval for KEYTRUDA at a fixed dose of 200 mg administered intravenously every three weeks in combination with pemetrexed 500 mg/m2 administered as an IV infusion over 10 minutes every three weeks, and carboplatin AUC 5 mg/mL/min every three 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.
KEYTRUDA (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 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; and for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS of one percent or more) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Merck has an extensive development program in NSCLC and is currently advancing multiple registration-enabling studies with KEYTRUDA as monotherapy and in combination with other treatments.
