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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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