Five Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel for Previously Treated, Programmed Death-Ligand 1-Positive Advanced NSCLC
Por:
Herbst, RS, Garon, EB, Kim, DW, Cho, BC, Gervais, R, Perez-Gracia, JL, Han, JY, Majem, M, Forster, MD, Monnet, I, Novello, S, Gubens, MA, Boyer, M, Su, WC, Samkari, A, Jensen, EH, Kobie, J, Piperdi, B, Baas, P
Publicada:
1 oct 2021
Ahead of Print:
1 sep 2021
Resumen:
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(2) 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 (similar to 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. (C) 2021 Published by Elsevier Inc. on behalf of International Association for the Study of Lung Cancer.
Filiaciones:
Herbst, RS:
Yale Univ, Sch Med, Yale Comprehens Canc Ctr, Sect Med Oncol, 333 Cedar St, New Haven, CT USA
Garon, EB:
Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA USA
Kim, DW:
Seoul Natl Univ, Coll Med, Seoul Natl Univ Hosp, Seoul, South Korea
Cho, BC:
Yonsei Univ, Yonsei Canc Ctr, Coll Med, Seoul, South Korea
Gervais, R:
Ctr Francois Baclesse, Caen, France
Perez-Gracia, JL:
Clin Univ Navarra, Pamplona, Spain
Han, JY:
Natl Canc Ctr, Ctr Lung Canc, Goyang, South Korea
Majem, M:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Forster, MD:
Univ Coll London Hosp, UCL Canc Inst, London, England
Monnet, I:
Ctr Hosp Intercommunal Creteil, Creteil, France
Novello, S:
Univ Turin, Azienda Ospedaliero Univ San Luigi, Dept Oncol, Turin, Italy
Gubens, MA:
Univ Calif San Francisco, San Francisco, CA 94143 USA
Boyer, M:
Chris Obrien Lifehouse, Camperdown, NSW, Australia
Su, WC:
Natl Cheng Kung Univ Hosp, Tainan, Taiwan
Samkari, A:
Merck & Co Inc, Kenilworth, NJ USA
Jensen, EH:
Merck & Co Inc, Kenilworth, NJ USA
Kobie, J:
Merck & Co Inc, Kenilworth, NJ USA
Piperdi, B:
Merck & Co Inc, Kenilworth, NJ USA
Baas, P:
Netherlands Canc Inst, Amsterdam, Netherlands
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