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A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407
Open accessAbstract
INTRODUCTION In the randomized KEYNOTE-407 study (ClinicalTrials.gov, NCT02775435), pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel (chemotherapy) significantly improved overall survival (OS) and progression-free survival (PFS) versus placebo plus chemotherapy in patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC). We report updated efficacy outcomes from the protocol-specified final analysis and, for the first time, progression on next-line of treatment. METHODS Eligible patients were randomized to chemotherapy plus either pembrolizumab (n=278) or placebo (n=281). After positive results from the second interim analysis, patients still receiving placebo could crossover to pembrolizumab monotherapy at time of confirmed progressive disease. Primary endpoints were OS and PFS. PFS-2 (time from randomization to progression on next-line treatment/death, whichever occurred first) was an exploratory endpoint. RESULTS After median (range) follow-up of 14.3 (0.1-31.3) months, pembrolizumab plus chemotherapy continued to demonstrate a clinically meaningful improvement over placebo plus chemotherapy in OS (median [95%CI], 17.1 [14.4‒19.9] versus 11.6 [10.1‒13.7] months; hazard ratio [HR (95%CI)], 0.71 [0.58‒0.88]) and PFS (median, 8.0 [6.3‒8.4] versus 5.1 [4.3‒6.0] months; HR [95%CI], 0.57 [0.47‒0.69]). PFS-2 was longer for patients randomized to first-line pembrolizumab plus chemotherapy (HR [95% CI], 0.59 [0.49‒0.72]). Grade 3‒5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively. CONCLUSION Pembrolizumab plus chemotherapy continued to demonstrate substantially improved OS and PFS in patients with metastatic squamous NSCLC. The PFS-2 outcomes support pembrolizumab plus chemotherapy as a standard first-line treatment in patients with metastatic squamous NSCLC.
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Self-citationPembrolizumab plus chemotherapy for squamous non-small-cell lung cancer
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Powles, T., Csőszi, T., Özgüroğlu, M., Matsubara, N., Géczi, L., Cheng, S. Y.-S., Fradet, Y., Oudard, S., Vulsteke, C., Morales Barrera, R., et al. (2021) · The Lancet Oncology · doi:10.1016/s1470-2045(21)00152-2 · Cited by 643
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Brahmer, J. R., Lee, J.-S., Ciuleanu, T.-E., Bernabe Caro, R., Nishio, M., Urban, L., Audigier-Valette, C., Lupinacci, L., Sangha, R., Pluzanski, A., et al. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.22.01503 · Cited by 406
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Metadata
- Authors
- Paz-Ares, L., Vicente, D., Tafreshi, A., Robinson, A., Soto Parra, H., Mazières, J., Hermes, B., Cicin, I., Medgyasszay, B., Rodríguez-Cid, J., Okamoto, I., Lee, S., Ramlau, R., Vladimirov, V., Cheng, Y., Deng, X., Zhang, Y., Bas, T., Piperdi, B., & Halmos, B.
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2020-10
- Volume
- 15
- Issue
- 10
- Pages
- 1657-1669
- ISSN
- 1556-0864 (ISSN-L)
- OpenAlex
- W3037506839
- Cited by
- 631
- References
- 20
- FWCI
- 51.72
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Paz-Ares, L., Vicente, D., Tafreshi, A., Robinson, A., Soto Parra, H., Mazières, J., Hermes, B., Cicin, I., Medgyasszay, B., Rodríguez-Cid, J., Okamoto, I., Lee, S., Ramlau, R., Vladimirov, V., Cheng, Y., Deng, X., Zhang, Y., Bas, T., Piperdi, B., & Halmos, B. (2020). A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2020.06.015
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