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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

Open access
Herbst, Roy S., Garon, Edward B., Kim, Dong-Wan, Cho, Byoung Chul, Perez-Gracia, Jose L., Han, Ji-Youn, Arvis, Catherine Dubos, Majem, Margarita, Forster, Martin D., Monnet, Isabelle, Novello, Silvia, Szalai, Zsuzsanna, Gubens, Matthew A., Su, Wu-Chou, Ceresoli, Giovanni Luca, Samkari, Ayman, Jensen, Erin H., Lubiniecki, Gregory M., Baas, Paul·2020·Journal of Clinical Oncology

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/m 2 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.

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Metadata

Authors
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.
Venue
Journal of Clinical Oncology
Published
2020-05-10
Volume
38
Issue
14
Pages
1580-1590
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W3007099934
Cited by
281
References
15
FWCI
15.56
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.1200/jco.19.02446
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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. https://doi.org/10.1200/jco.19.02446

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.