Regeneron’s Libtayo (cemiplimab) Receives EC’s Approval as the 2L Treatment of Recurrent or Metastatic Cervical Cancer


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