Study
Double-blind, placebo-controlled, phase 3 study |
Untreated advanced or metastatic NSCLC |
Group A (Cemiplimab + chemotherapy (n=312)) vs. group B (chemotherapy alone (n=154)) |
Efficacy
mOS : 21.9 vs. 13.0 mos (HR = 0.71, p= 0.014) |
mPFS: 8.2 vs. 5.0 mos (HR = 0.56, p < 0.001) |
ORR: 43.3% vs. 22.7% (OR:2.68) |
CR: 2.7% vs. 0% |
Safety
Any grade AEs: 95.8% vs 94.1% |
Grade ≥3 AEs: anemia (9.9% vs. 6.5%); neutropenia (5.9% vs 5.8%) |
Nat Med. 2022; 28(11): 2374–2380
http://doi.org/10.1038/s41591-022-01977-y
Reviewed by Elvin Chalabiyev, MD on Jan 10, 2023