The EC has approved Libtayo as monotx. in adult patients with recurrent or metastatic cervical cancer & disease progression on or after Pt-based CT
The approval was based on the P-III (EMPOWER-Cervical 1) trial evaluating Libtayo (350mg, q3w) as monotx. vs CT in 608 patients across 14 countries irrespective of PD-L1 expression status or histology which showed an improvement in OS, PFS & ORR, 31% & 27% reduction in risk of death & a longer m-OS in the overall population & SCC histology (12.0 vs 8.5mos. & 11.1 vs 8.8mos.), 25% reduction of risk in progressive disease while ORR (16% vs 6%) in the overall population
Immune-mediated adverse reactions (21%), permanent discontinuation (4.6%) with no new Libtayo safety signals. The results were published in NEJM
Ref: Regeneron | Image: Regeneron
