Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC

Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC


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  • The P-III (EMPOWER-Lung 3) trial assessed Libtayo (350mg, Q3W for 108wks.; n=312) vs PBO (n=154), both with Pt-based CT (Q3W ×4 cycles), in 466 adults with LA/M NSCLC harboring no EGFR, ALK, or ROS1 alteration
  • At mFU of 60.9mos., trial showed a 34% reduction in death risk (mOS: 21.1 vs 12.9mos.; 5yr. survival probability: 19.4% vs 8.8%) & a 42% decrease in progression risk (mPFS: 8.2 vs 5.5mos.), with ORR of 43.6% vs 22.1% (CR: 6.4% vs 0%) & mDoR of 16.4 vs 7.3mos.
  • Exploratory subgroup analyses showed reduced death risk by 32% in squamous (mOS: 22.3 vs 13.8 mos.), 38% in non-squamous (19.4 vs 12.4mos.) & 46% in PD-L1 ≥1% (24 vs 12.1mos.), regardless of histology or PD-L1 status; data presented at WCLC’25

Ref: Regeneron | Image: Regeneron | Press Release

Related News:- Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

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