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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.
ORCID http://orcid.org/0000-0002-2339-6509
Keywords pembrolizumab
KEYNOTE-033
oncology
docetaxel
cancer
immunotherapy
NSCLC
pembrolizumab
programmed death 1
programmed death-ligand 1
Type Article
Date of Issue 2023
URI https://essuir.sumdu.edu.ua/handle/123456789/93767
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.
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