A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407

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dc.authoridSOTO PARRA, HECTOR J/0000-0001-7966-4472
dc.authoridSOTO PARRA, HECTOR J/0000-0001-7966-4472
dc.authoridPiperdi, Bilal/0000-0002-1315-3175
dc.authorwosidzhen, wang/KBA-3844-2024
dc.authorwosidSOTO PARRA, HECTOR J/ABC-6273-2021
dc.authorwosidSOTO PARRA, HECTOR J/IZE-2180-2023
dc.authorwosidMAZIERES, JULIEN/M-3986-2014
dc.contributor.authorPaz-Ares, Luis
dc.contributor.authorVicente, David
dc.contributor.authorTafreshi, Ali
dc.contributor.authorRobinson, Andrew
dc.contributor.authorParra, Hector Soto
dc.contributor.authorMazieres, Julien
dc.contributor.authorHermes, Barbara
dc.date.accessioned2024-06-12T11:12:08Z
dc.date.available2024-06-12T11:12:08Z
dc.date.issued2020
dc.departmentTrakya Üniversitesien_US
dc.description.abstractIntroduction: 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) compared with placebo plus chemotherapy in patients with previously untreated metastatic squamous 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 cross over to pembrolizumab monotherapy at the time of confirmed progressive disease. The primary end points were OS and PFS. PFS-2 (time from randomization to progression on next-line treatment/death, whichever occurred first) was an exploratory end point. Results: After median (range) follow-up of 14.3 (0.1-31.3) months, pembrolizumab plus chemotherapy continued to exhibit a clinically meaningful improvement over placebo plus chemotherapy in OS (median, 17.1 mo [95% confidence interval (CI): 14.4-19.9] versus 11.6 mo [95% CI: 10.1-13.7]; hazard ratio [HR], 0.71 [95% CI: 0.58-0.88]) and PFS (median, 8.0 mo [95% CI: 6.3-8.4] versus 5.1 mo [95% CI: 4.3-6.0]; HR, 0.57 [95% CI: 0.47-0.69]). PFS-2 was longer for patients randomized to first-line pembrolizumab plus chemotherapy (HR, 0.59 [95% CI: 0.49-0.72]). Grade 3 to 5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively. Conclusions: Pembrolizumab plus chemotherapy continued to exhibit 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. (C) 2020 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.en_US
dc.description.sponsorshipMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jerseyen_US
dc.description.sponsorshipThis research was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey. The authors thank the patients and their families and caregivers for participating in this study along with all investigators and site personnel. Medical writing assistance was provided by Shelly Lim, PhD, of ICON plc (North Wales, PA), a CHC Group company, and was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey.en_US
dc.identifier.doi10.1016/j.jtho.2020.06.015
dc.identifier.endpage1669en_US
dc.identifier.issn1556-0864
dc.identifier.issn1556-1380
dc.identifier.issue10en_US
dc.identifier.pmid32599071en_US
dc.identifier.scopus2-s2.0-85089450134en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage1657en_US
dc.identifier.urihttps://doi.org/10.1016/j.jtho.2020.06.015
dc.identifier.urihttps://hdl.handle.net/20.500.14551/23062
dc.identifier.volume15en_US
dc.identifier.wosWOS:000576696100025en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevier Science Incen_US
dc.relation.ispartofJournal Of Thoracic Oncologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectPD-L1en_US
dc.subjectPembrolizumaben_US
dc.subjectChemotherapyen_US
dc.subjectSquamous Non-Small-Cell Lung Canceren_US
dc.subject1st-Line Therapyen_US
dc.subjectCanceren_US
dc.subjectSurvivalen_US
dc.titleA Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407en_US
dc.typeArticleen_US

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