The Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line treatment of adults with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. The indication applies to patients with either metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation.
The approval was based on data from the randomized, multicenter, double-blind, active-controlled phase 3 EMPOWER-Lung 3 trial (ClinicalTrials.gov Identifier: NCT03409614), which evaluated the efficacy and safety of cemiplimab-rwlc, a programmed death receptor-1 (PD-1) blocking antibody, in 466 patients with advanced NSCLC who had not received prior systemic treatment. Patients were eligible regardless of tumor PD-L1 expression status.
Patients were randomly assigned 2:1 to receive cemiplimab-rwlc 350mg (n=312) or placebo (n=154) intravenously (IV) every 3 weeks for 108 weeks plus platinum-based chemotherapy every 3 weeks for 4 cycles. The primary endpoint was overall survival (OS). Key secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and duration of response (DOR).
Treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in OS with a 29% relative reduction in the risk of death vs placebo plus platinum-based chemotherapy (hazard ratio [HR], 0.71; 95% CI, 0.53-0.93; P =.014). Median OS was 21.9 months for the cemiplimab-rwlc plus chemotherapy arm and 13 months for the placebo plus chemotherapy arm.
Median PFS was 8.2 months with cemiplimab-rwlc plus chemotherapy and 5 months with placebo plus chemotherapy (HR, 0.56; 95% CI, 0.44-0.70; P <.0001). The ORR was 43% (95% CI, 38-49) for the cemiplimab-rwlc plus chemotherapy arm and 23% (95% CI, 16-30) for the placebo plus chemotherapy arm (P <.0001). Median DOR was 15.6 months and 7.3 months for the cemiplimab-rwlc plus chemotherapy and placebo plus chemotherapy arms, respectively.
The most common adverse reactions reported were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.
“Libtayo is now approved for extending the survival of patients with advanced non-small cell lung cancer as both a monotherapy in high PD-L1 expressors and in combination with chemotherapy irrespective of PD-L1 expression levels, achieving a high bar that has only been met by one other PD-1 targeting agent,” said Israel Lowy, MD, PhD, Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron.
- Libtayo® (cemiplimab-rwlc) in combination with chemotherapy approved by the FDA as first-line treatment for advanced non-small cell lung cancer (NSCLC). News release. Regeneron Pharmaceuticals, Inc. November 8, 2022. Accessed November 9, 2022. https://www.prnewswire.com/news-releases/libtayo-cemiplimab-rwlc-in-combination-with-chemotherapy-approved-by-the-fda-as-first-line-treatment-for-advanced-non-small-cell-lung-cancer-nsclc-301672231.html
- FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer. News release. US Food and Drug Administration. November 8, 2022. Accessed November 9, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-combination-platinum-based-chemotherapy-non-small-cell-lung-cancer
- Libtayo. Package insert. Regeneron Pharmaceuticals, Inc; 2022. Accessed November 9, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761097s014lbl.pdf