Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1‒Positive, Advanced Non‒Small-Cell Lung Cancer in the KEYNOTE-010 Study

Roy S. Herbst, Edward B. Garon, Dong Wan Kim, Byoung Chul Cho, Jose L. Perez-Gracia, Ji Youn Han, Catherine Dubos Arvis, Margarita Majem, Martin D. Forster, Isabelle Monnet, Silvia Novello, Zsuzsanna Szalai, Matthew A. Gubens, Wu Chou Su, Giovanni Luca Ceresoli, Ayman Samkari, Erin H. Jensen, Gregory M. Lubiniecki, Paul Baas

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Abstract

PURPOSE: In the KEYNOTE-010 study, pembrolizumab improved overall survival (OS) versus docetaxel in previously treated, programmed death-ligand 1 (PD-L1)‒expressing advanced non‒small-cell lung cancer (NSCLC) in patients with a tumor proportion score (TPS) ≥ 50% and ≥ 1%. We report KEYNOTE-010 long-term outcomes, including after 35 cycles/2 years or second-course pembrolizumab. METHODS: Of 1,033 patients randomly assigned (intention to treat), 690 received up to 35 cycles/2 years of pembrolizumab 2 mg/kg (n = 344) or 10 mg/kg (n = 346) every 3 weeks, and 343 received docetaxel 75 mg/m2 every 3 weeks. Eligible patients with disease progression after 35 cycles/2 years of pembrolizumab could receive second-course treatment (up to 17 cycles). Pembrolizumab doses were pooled because no between-dose difference was observed at primary analysis. RESULTS: Pembrolizumab continued to improve OS over docetaxel in the PD-L1 TPS ≥ 50% and ≥ 1% groups (hazard ratio [HR], 0.53; 95% CI, 0.42 to 0.66; P < .00001; and HR, 0.69; 95% CI, 0.60 to 0.80; P < .00001, respectively) after a 42.6-month (range, 35.2-53.2 months) median follow-up. Estimated 36-month OS rates were 34.5% versus 12.7% and 22.9% versus 11.0%, respectively. Grade 3-5 treatment-related adverse events occurred in 16% versus 37% of patients, respectively. Seventy-nine of 690 patients completed 35 cycles/2 years of pembrolizumab; 12-month OS and progression-free survival rates after completing treatment were 98.7% (95% CI, 91.1% to 99.8%) and 72.5% (95% CI, 59.9% to 81.8%), respectively. Seventy-five patients (95%) had objective response (RECIST v1.1, blinded independent central review) and 48 (64%) had ongoing response. Grade 3-5 treatment-related adverse events occurred in 17.7% of patients. Fourteen patients received second-course pembrolizumab: 5 completed 17 cycles, 6 (43%) had partial response, and 5 (36%) had stable disease. CONCLUSION: Pembrolizumab provided long-term OS benefit over docetaxel, with manageable safety, durable responses among patients receiving 2 years of treatment, and disease control with second-course treatment, further supporting pembrolizumab for previously treated, PD-L1‒expressing advanced NSCLC.

Original languageEnglish
Pages (from-to)1580-1590
Number of pages11
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume38
Issue number14
DOIs
Publication statusPublished - 2020 May 10

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    Herbst, R. S., Garon, E. B., Kim, D. W., Cho, B. C., Perez-Gracia, J. L., Han, J. Y., Arvis, C. D., Majem, M., Forster, M. D., Monnet, I., Novello, S., Szalai, Z., Gubens, M. A., Su, W. C., Ceresoli, G. L., Samkari, A., Jensen, E. H., Lubiniecki, G. M., & Baas, P. (2020). Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1‒Positive, Advanced Non‒Small-Cell Lung Cancer in the KEYNOTE-010 Study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 38(14), 1580-1590. https://doi.org/10.1200/JCO.19.02446