Please use this identifier to cite or link to this item:
Or use following links to share this resource in social networks: Recommend this item
Title KEYNOTE-033: Randomized phase 3 study of pembrolizumab vs docetaxel in previously treated, PD-L1-positive, advanced NSCLC
Authors Ren, S.
Feng, J.
Ma, S.
Chen, H.
Ma, Z.
Huang, C.
Zhang, L.
He, J.
Wang, C.
Zhou, J.
Danchaivijitr, P.
Wang, C.-C.
Vynnychenko, Ihor Oleksandrovych  
Wang, K.
Orlandi, F.
Sriuranpong, V.
Li, B.
Ge, J.
Dang, T.
Zhou, C.
Keywords pembrolizumab
programmed death 1
programmed death-ligand 1
Type Article
Date of Issue 2023
Publisher International Journal of Cancer
License Creative Commons Attribution - NonCommercial - NoDerivatives 4.0 International
Citation Ren S, Feng J, Ma S, et al.KEYNOTE-033: Randomized phase 3 study of pembrolizumabvs docetaxel in previously treated, PD-L1-positive, advancedNSCLC.Int J Cancer. 2023;153(3):623‐634. doi:10.1002/ijc.34532
Abstract KEYNOTE-033 (NCT02864394) was a multicountry, open-label, phase 3 study that compared pembrolizumab vs docetaxel in previously treated, programmed death- ligand 1 (PD-L1)-positive, advanced non-small cell lung cancer (NSCLC), with most patients enrolled in mainland China. Eligible patients were randomized (1:1) to pem- brolizumab 2 mg/kg or docetaxel 75 mg/m2 every 3 weeks. Primary endpoints were overall survival (OS) and progression-free survival and were evaluated sequentially using stratified log-rank tests, first in patients with PD-L1 tumor proportion score (TPS) ≥50% and then in patients with PD-L1 TPS ≥1% (significance threshold: P < .025, one-sided). A total of 425 patients were randomized to pembrolizumab (N = 213) or docetaxel (N = 212) between 8 September 2016 and 17 October 2018. In patients with a PD-L1 TPS ≥50% (n = 227), median OS was 12.3 months with pembrolizumab and 10.9 months with docetaxel; the hazard ratio (HR) was 0.83 (95% confidence interval [CI]: 0.61-1.14; P = .1276). Because the significance threshold was not met, sequential testing of OS and PFS was ceased. In patients with a PD-L1 TPS ≥1%, the HR for OS for pembrolizumab vs docetaxel was 0.75 (95% CI: 0.60-0.95). In patients from mainland China (n = 311) with a PD-L1 TPS ≥1%, HR for OS was 0.68 (95% CI: 0.51-0.89). Incidence of grade 3 to 5 treatment- related AEs was 11.3% with pembrolizumab vs 47.5% with docetaxel. In summary, pembrolizumab improved OS vs docetaxel in previously treated, PD-L1-positive NSCLC without unexpected safety signals; although the statistical significance threshold was not reached, the numerical improvement is consistent with that pre- viously observed for pembrolizumab in previously treated, advanced NSCLC.
Appears in Collections: Наукові видання (НН МІ)


China China
Singapore Singapore
Ukraine Ukraine
United States United States
Unknown Country Unknown Country


Ukraine Ukraine
United States United States
Unknown Country Unknown Country


File Size Format Downloads
Vynnychenko_KEYNOTE.pdf 939,06 kB Adobe PDF 68

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.