Cemiplimab-rwlc Demonstrates Significant Improvement in Overall Survival for Certain Patients With NSCLC

The EMPOWER-Lung 3 phase 3 trial of cemiplimab-rwlc (Libtayo, Regeneron) in combination with platinum-doublet chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) was stopped early after meeting its overall survival (OS) primary endpoint, according to a press release from Regeneron. The investigators found that the combination of cemiplimab-rwlc and chemotherapy resulted in a substantial improvement in OS compared to chemotherapy alone for patients with metastatic or locally advanced disease and tumors with either squamous or non-squamous histology and across all programmed death-ligand 1 (PD-L1) expression levels.

The decision to stop the trial early was made based on the recommendations of the Independent Data Monitoring Committee (IDMC) during a protocol-specified interim analysis. This initial top-line analysis examined 466 patients with NSCLC and found that combining cemiplimab-rwlc with chemotherapy reduced the risk of death by 29% compared to chemotherapy alone. The median OS was 22 months in the cemiplimab-rwlc cohort, compared to 13 months for patients receiving chemotherapy alone.

"Libtayo in combination with chemotherapy increased median overall survival to 22 months in patients with advanced non-small cell lung cancer, compared to 13 months with chemotherapy alone," said Miranda Gogishvili, MD, in the release. "Notably, the phase 3 trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease. These data add to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also include the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression."

EMPOWER-Lung 3 was a randomized, multicenter phase 3 trial that focused on 466 patients who tested negative for ALK, EGFR, and ROS1 mutations and had either previously untreated metastatic NSCLC (stage 4) or locally advanced NSCLC (stage 3B/C) and were not candidates for definitive chemoradiation. Participants were randomized 2:1 to receive either cemiplimab-rwlc 350 mg or placebo, administered intravenously every 3 weeks for 108 weeks. The co-primary endpoints were OS and progression-free survival, with key secondary endpoints including objective response rate and best overall response.

REFERENCE

Phase 3 trial of Libtayo (cemiplimab-rwlc) combined with chemotherapy stopped early due to significant improvement in overall survival in patients with first-line advanced non-small cell lung cancer [news release]. Regeneron; August 5, 2021. Accessed August 9, 2021. https://investor.regeneron.com/index.php/news-releases/news-release-details/phase-3-trial-libtayor-cemiplimab-rwlc-combined-chemotherapy