The sBLA is reinforced by results from a randomized phase 3 trial that investigated cemiplimab-rwlc in combination with a physician’s choice of platinum-doublet chemotherapy compared to platinum-doublet chemotherapy alone.
The FDA has accepted a supplemental Biologics License Application (sBLA) for the PD-1 inhibitor cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC), according to a Regeneron press release.
The sBLA is reinforced by results from a randomized phase 3 trial that investigated cemiplimab-rwlc in combination with a physician’s choice of platinum-doublet chemotherapy compared to platinum-doublet chemotherapy alone. Enrolled patients had locally advanced or metastatic NSCLC with no ALK, EGFR, or ROS1 aberrations.
The results of the phase 3 study found that among patients in the cemiplimab-rwlc combination and chemotherapy alone groups, treatment discontinuations due to adverse events (AEs) occurred in 5% and 3% of patients, respectively. Immune-mediated AEs occurred in 19% of patients in the cemiplimab-rwlc combination group.
Among the patients enrolled in the trial, 43% had tumors with squamous histology, 67% had tumors with <50% PD-L1 expression, 15% had inoperable locally advanced disease not eligible for definitive chemoradiation, and 7% had pretreated and clinically stable brain metastases. Additionally, 84% of patients had an ECOG 1 performance status, indicating the presence of cancer-related symptoms, according to the press release.
Cemiplimab-rwlc was approved in the United States and European Union in 2021 as first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression, as determined by an FDA-approved test.
FDA accepts for review libtayo® (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC. Regeneron Pharmaceuticals. January 19, 2022. Accessed January 19, 2022. https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-review-libtayor-cemiplimab-rwlc-combination