Cemiplimab regimen extends OS in advanced NSCLC
Click Here to Manage Email Alerts
A phase 3 trial of cemiplimab-rwlc plus chemotherapy as first-line treatment for patients with advanced non-small cell lung cancer has been stopped early after achieving its primary endpoint of improved OS, according to the agent’s manufacturer.
The independent data monitoring committee recommended early termination of the EMPOWER-Lung 3 trial after a protocol-specified interim analysis showed the combination of cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals), a PD-1 inhibitor, and platinum-doublet chemotherapy reduced the risk for death by 29% (HR = 0.71; 95% CI, 0.53-0.93) compared with chemotherapy alone.
The trial included 466 patients with untreated metastatic or locally advanced squamous or nonsquamous advanced NSCLC.
All trial participants tested negative for ALK, EGFR and ROS1 mutations and did not qualify for definitive chemoradiation. One-third of patients had tumors with at least 50% PD-L1 expression, 38% had expression levels of 1% to 49%, and 30% had expression of less than 1%.
Researchers randomly assigned patients to platinum-doublet chemotherapy every 3 weeks for four cycles plus either 350 mg cemiplimab-rwlc (n = 312) or placebo (n = 154) via IV every 3 weeks for 108 weeks.
OS and PFS served as co-primary endpoints. Objective response rate and best overall response served as key secondary endpoints.
Results showed median OS of 22 months (95% CI, 16 to not evaluable) with the combination vs. 13 months (95% CI, 12-16) with chemotherapy alone. The interim analysis also revealed no new safety signals with cemiplimab-rwlc.
“Notably, the phase 3 trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease,” Miranda Gogishvili, MD, a trial investigator and oncologist at High Technology Medical Center, University Clinic, in Tbilisi, Georgia, said in a Regeneron-issued press release. “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.”
The data will serve as the basis of regulatory submissions in the U.S. and European Union, according to the press release. Additional safety and efficacy data will be presented at a medical meeting.
Earlier this year, the FDA approved cemiplimab-rwlc monotherapy as first-line treatment for patients with metastatic or locally advanced NSCLC who have high tumor PD-L1 expression, are not candidates for surgical resection or definitive chemoradiation, and do not have ALK, EGFR and ROS1 mutations.
Read more about
Click Here to Manage Email Alerts