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Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study
Open accessAbstract
PURPOSE: Pembrolizumab monotherapy has demonstrated durable antitumor activity in advanced programmed death ligand 1 (PD-L1)–expressing non‒small-cell lung cancer (NSCLC). We report 5-year outcomes from the phase Ib KEYNOTE-001 study. These data provide the longest efficacy and safety follow-up for patients with NSCLC treated with pembrolizumab monotherapy. PATIENTS AND METHODS: Eligible patients had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by immunohistochemistry using the 22C3 antibody. Patients received intravenous pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks. Investigators assessed response per immune-related response criteria. The primary efficacy end point was objective response rate. Overall survival (OS) and duration of response were secondary end points. RESULTS: We enrolled 101 treatment-naive and 449 previously treated patients. Median follow-up was 60.6 months (range, 51.8 to 77.9 months). At data cutoff—November 5, 2018—450 patients (82%) had died. Median OS was 22.3 months (95% CI, 17.1 to 32.3 months) in treatment-naive patients and 10.5 months (95% CI, 8.6 to 13.2 months) in previously treated patients. Estimated 5-year OS was 23.2% for treatment-naive patients and 15.5% for previously treated patients. In patients with a PD-L1 tumor proportion score of 50% or greater, 5-year OS was 29.6% and 25.0% in treatment-naive and previously treated patients, respectively. Compared with analysis at 3 years, only three new-onset treatment-related grade 3 adverse events occurred (hypertension, glucose intolerance, and hypersensitivity reaction, all resolved). No late-onset grade 4 or 5 treatment-related adverse events occurred. CONCLUSION: Pembrolizumab monotherapy provided durable antitumor activity and high 5-year OS rates in patients with treatment-naive or previously treated advanced NSCLC. Of note, the 5-year OS rate exceeded 25% among patients with a PD-L1 tumor proportion score of 50% or greater. Pembrolizumab had a tolerable long-term safety profile with little evidence of late-onset or new toxicity.
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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
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Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer
Reck, M., Rodríguez-Abreu, D., Robinson, A. G., Hui, R., Csőszi, T., Fülöp, A., Gottfried, M., Peled, N., Tafreshi, A., Cuffe, S., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1606774 · Cited by 10,089
Self-citationPembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer
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Self-citationHerbst, R. S., Baas, P., Kim, D.-W., Felip, E., Pérez-Gracia, J. L., Han, J.-Y., Molina, J., Kim, J.-H., Arvis, C. D., Ahn, M.-J., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(15)01281-7 · Cited by 6,449
Self-citationPembrolizumab for the Treatment of Non–Small-Cell Lung Cancer
Garon, E. B., Rizvi, N. A., Hui, R., Leighl, N., Balmanoukian, A. S., Eder, J. P., Patnaik, A., Aggarwal, C., Gubens, M., Horn, L., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1501824 · Cited by 6,198
Self-citationPembrolizumab plus chemotherapy for squamous non-small-cell lung cancer
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Self-citationWolchok, J. D., Hoos, A., O'Day, S., Weber, J. S., Hamid, O., Lebbé, C., Maio, M., Binder, M., Bohnsack, O., Nichol, G., et al. (2009) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-09-1624 · Cited by 3,222
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Cited by
Paz-Ares, L., Dvorkin, M., Chen, Y., Reinmuth, N., Hotta, K., Trukhin, D., Statsenko, G., Hochmair, M. J., Özgüroğlu, M., Ji, J. H., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32222-6 · Cited by 2,298
Self-citationPD-L1 as a biomarker of response to immune-checkpoint inhibitors
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Ettinger, D. S., Wood, D. E., Aisner, D. L., Akerley, W., Bauman, J. R., Bharat, A., Bruno, D. S., Chang, J. Y., Chirieac, L. R., D’Amico, T. A., et al. (2021) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2021.0013 · Cited by 948
Self-citationImmune-checkpoint inhibitors: long-term implications of toxicity
Johnson, D. B., Nebhan, C. A., Moslehi, J. J., & Balko, J. M. (2022) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-022-00600-w · Cited by 982
Powles, T., Plimack, E. R., Soulières, D., Waddell, T., Stus, V., Gafanov, R., Nosov, D., Pouliot, F., Melichar, B., Vynnychenko, I., et al. (2020) · The Lancet Oncology · doi:10.1016/s1470-2045(20)30436-8 · Cited by 751
Metadata
- Authors
- Garon, E. B., Hellmann, M. D., Rizvi, N. A., Carcereny, E., Leighl, N. B., Ahn, M.-J., Eder, J. P., Balmanoukian, A. S., Aggarwal, C., Horn, L., Patnaik, A., Gubens, M., Ramalingam, S. S., Felip, E., Goldman, J. W., Scalzo, C., Jensen, E., Kush, D. A., & Hui, R.
- Venue
- Journal of Clinical Oncology
- Published
- 2019-10-01
- Volume
- 37
- Issue
- 28
- Pages
- 2518-2527
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2947775394
- Cited by
- 1,163
- References
- 24
- FWCI
- 57.59
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Garon, E. B., Hellmann, M. D., Rizvi, N. A., Carcereny, E., Leighl, N. B., Ahn, M.-J., Eder, J. P., Balmanoukian, A. S., Aggarwal, C., Horn, L., Patnaik, A., Gubens, M., Ramalingam, S. S., Felip, E., Goldman, J. W., Scalzo, C., Jensen, E., Kush, D. A., & Hui, R. (2019). Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.19.00934
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