Five Year Survival Update From KEYNOTE-010 : Pembrolizumab Versus Docetaxel for Previously Treated, Programmed Death-Ligand 1-Positive Advanced NSCLC
Herbst, Roy S (Section of Medical Oncology. Yale Comprehensive Cancer Center. Yale University School of Medicine)
Garon, E.B. (David Geffen School of Medicine. University of California Los Angeles)
Kim, D.W. (Seoul National University Hospital. Seoul National University College of Medicine)
Cho, B.C. (Yonsei Cancer Center. Yonsei University College of Medicine)
Gervais, R. (Centre François Baclesse (Caen, França))
Perez-Gracia, J.L. (Clínica Universidad de Navarra)
Han, J.Y. (Center for Lung Cancer. National Cancer Center)
Majem, Margarita (Institut d'Investigació Biomèdica Sant Pau)
Forster, M.D. (UCL Cancer Institute/University College London Hospitals)
Monnet, Isabelle (Centre Hospitalier Intercommunal de Créteil)
Novello, Silvia (Department of Oncology. University of Turin. Azienda Ospedaliero Universitaria San Luigi)
Gubens, M.A. (University of California. San Francisco)
Boyer, M. (Chris O'Brien Lifehouse)
Su, W.C. (National Cheng Kung University Hospital)
Samkari, A. (Merck & Co.. Inc.)
Jensen, E.H. (Merck & Co.. Inc.)
Kobie, J. (Merck & Co.. Inc.)
Piperdi, B. (Merck & Co.. Inc.)
Baas, Pieter (The Netherlands Cancer Institute (Amsterdam, Països Baixos))

Date:	2021
Abstract:	Introduction: In the KEYNOTE-010 study, pembrolizumab improved overall survival (OS) versus docetaxel in patients with previously treated, advanced NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% and ≥1%. We report 5-year efficacy and safety follow-up for the KEYNOTE-010 study. Methods: Patients were randomized to pembrolizumab 2 mg/kg or 10 mg/kg once every 3 weeks or docetaxel 75 mg/m once every 3 weeks for up to 35 cycles (2 y). Patients who completed pembrolizumab treatment and subsequently had recurrence could receive second-course pembrolizumab for up to 17 cycles (1 y). Pembrolizumab doses were pooled in this analysis. Results: A total of 1034 patients were randomized (pembrolizumab, n = 691; docetaxel, n = 343). Median study follow-up was 67. 4 months (range: 60. 0‒77. 9). The hazard ratio (95% confidence interval) for OS was 0. 55 (0. 44‒0. 69) for patients with PD-L1 TPS ≥50% and 0. 70 (0. 61‒0. 80) with PD-L1 TPS ≥1%. The 5-year OS rates for pembrolizumab versus docetaxel were 25. 0% versus 8. 2% in patients with PD-L1 TPS ≥50% and 15. 6% versus 6. 5% with PD-L1 TPS ≥1%. Among 79 patients who completed 35 cycles/2 years of pembrolizumab, the OS rate 3 years after completion (∼5 y from randomization) was 83. 0%. A total of 21 patients received second-course pembrolizumab; 11 (52. 4%) had an objective response after starting the second course and 15 (71. 4%) were alive at data cutoff. Exploratory biomarker analysis revealed that higher tissue tumor mutational burden (≥175 mutations per exome) was associated with improved outcomes with pembrolizumab. Conclusions: Pembrolizumab continued to provide long-term benefit than docetaxel in patients with previously treated advanced NSCLC with PD-L1 TPS ≥50% and ≥1%. Our findings confirm pembrolizumab as a standard-of-care treatment in the second-line or later setting.
Note:	Altres ajuts: Merck Sharp & Dohme Corp.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Pembrolizumab ; Non‒small-cell lung cancer ; Chemotherapy ; PD-L1
Published in:	Journal of Thoracic Oncology, Vol. 16 Núm. 10 (october 2021) , p. 1718-1732, ISSN 1556-1380

DOI: 10.1016/j.jtho.2021.05.001
PMID: 34048946

15 p, 598.6 KB

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