First-line Libtayo plus chemotherapy receives approval in Canada for advanced NSCLC.- Regeneron
The regulatory decision was supported by data from the phase III EMPOWER-Lung 3 trial (Study 16113; NCT03409614), which showed that cemiplimab plus chemotherapy provided a statistically significant and clinically meaningful improvement in overall survival (OS) vs placebo plus chemotherapy (HR, 0.71; 95% CI, 0.53-0.93; 2-sided P = .0140). Patients treated in the cemiplimab arm (n = 312) experienced a median OS of 21.9 months (95% CI, 15.5-not evaluable) compared with 13.0 months (95% CI, 11.9-16.1) for those in the placebo arm (n = 154).
“The approval of this new indication of [cemiplimab] highlights continued progress in first-line treatment options for people impacted by advanced lung cancer in Canada,” Barb Melosky, MD, FRCPC, clinical professor of medicine at the University of British Columbia, stated in a news release. “The phase III EMPOWER-Lung 3 trial showed significant improvements across primary and key secondary end points, including OS in the cemiplimab plus chemotherapy arm.”
On 8 November 2022, the FDA approved cemiplimab in combination with platinum-based chemotherapy for the treatment of adult patients with advanced NSCLC with no EGFR, ALK, or ROS1 aberrations, based on data from EMPOWER-Lung 3.
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