This post-hoc analysis included pts with baseline liver mets from three phase 3 trials of cemiplimab (cemi; anti-PD-1) in non-small cell lung cancer (NSCLC) and cervical cancer...in EMPOWER-Lung 1 (1L treatment for advanced NSCLC with PD-L1 ≥50%), among pts with liver mets, cemiplimab monotherapy demonstrated notably longer OS (not reached vs 7.4 months; hazard ratio [HR] 0.38) and PFS (6.2 vs 4.2 months; HR 0.51), as well as higher ORR (29% vs 15%) vs chemo (Table). Similar improvement was observed for EMPOWER-Lung 3 Part 2 (1L cemiplimab+chemo vs placebo+chemo for advanced NSCLC with all PD-L1 levels). In EMPOWER-Cervical 1 (2L treatment of recurrent cervical cancer with all PD-L1 levels), cemiplimab showed comparable OS, PFS, and ORR vs chemo in the liver mets subgroup.

An objective response occurred in 18% (95% CI, 11 to 28) of the cemiplimab-treated patients with PD-L1 expression greater than or equal to 1% and in 11% (95% CI, 4 to 25) of those with PD-L1 expression of less than 1%.

Regeneron Pharmaceuticals...announced that the European Commission (EC) approved Libtayo® (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.