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Article: Five-Year Outcomes with Pembrolizumab Versus Chemotherapy for Metastatic Non–Small-Cell Lung Cancer with PD-L1 Tumor Proportion Score ‡ 50%

TitleFive-Year Outcomes with Pembrolizumab Versus Chemotherapy for Metastatic Non–Small-Cell Lung Cancer with PD-L1 Tumor Proportion Score ‡ 50%
Authors
Issue Date2021
Citation
Journal of Clinical Oncology, 2021, v. 39, n. 21, p. 2339-2349 How to Cite?
AbstractPURPOSE We report the first 5-year follow-up of any first-line phase III immunotherapy trial for non–small-cell lung cancer (NSCLC). KEYNOTE-024 (ClinicalTrials.gov identifier: NCT02142738) is an open-label, randomized controlled trial of pembrolizumab compared with platinum-based chemotherapy in patients with previously untreated NSCLC with a programmed death ligand-1 (PD-L1) tumor proportion score of at least 50% and no sensitizing EGFR or ALK alterations. Previous analyses showed pembrolizumab significantly improved progression-free survival and overall survival (OS). METHODS Eligible patients were randomly assigned (1:1) to pembrolizumab (200 mg once every 3 weeks for up to 35 cycles) or platinum-based chemotherapy. Patients in the chemotherapy group with progressive disease could cross over to pembrolizumab. The primary end point was progression-free survival; OS was a secondary end point. RESULTS Three hundred five patients were randomly assigned: 154 to pembrolizumab and 151 to chemotherapy. Median (range) time from randomization to data cutoff (June 1, 2020) was 59.9 (55.1-68.4) months. Among patients initially assigned to chemotherapy, 99 received subsequent anti–PD-1 or PD-L1 therapy, representing a 66.0% effective crossover rate. Median OS was 26.3 months (95% CI, 18.3 to 40.4) for pembrolizumab and 13.4 months (9.4-18.3) for chemotherapy (hazard ratio, 0.62; 95% CI, 0.48 to 0.81). Kaplan-Meier estimates of the 5-year OS rate were 31.9% for the pembrolizumab group and 16.3% for the chemotherapy group. Thirty-nine patients received 35 cycles (ie, approximately 2 years) of pembrolizumab, 82.1% of whom were still alive at data cutoff (approximately 5 years). Toxicity did not increase with longer treatment exposure. CONCLUSION Pembrolizumab provides a durable, clinically meaningful long-term OS benefit versus chemotherapy as first-line therapy for metastatic NSCLC with PD-L1 tumor proportion score of at least 50%.
Persistent Identifierhttp://hdl.handle.net/10722/326507
ISSN
2023 Impact Factor: 42.1
2023 SCImago Journal Rankings: 10.639
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorReck, Martin-
dc.contributor.authorRodríguez-Abreu, Delvys-
dc.contributor.authorRobinson, Andrew G.-
dc.contributor.authorHui, Rina-
dc.contributor.authorCsöszi, Tibor-
dc.contributor.authorFülöp, Andrea-
dc.contributor.authorGottfried, Maya-
dc.contributor.authorPeled, Nir-
dc.contributor.authorTafreshi, Ali-
dc.contributor.authorCuffe, Sinead-
dc.contributor.authorO’Brien, Mary-
dc.contributor.authorRao, Suman-
dc.contributor.authorHotta, Katsuyuki-
dc.contributor.authorLeal, Ticiana A.-
dc.contributor.authorRiess, Jonathan W.-
dc.contributor.authorJensen, Erin-
dc.contributor.authorZhao, Bin-
dc.contributor.authorPietanza, M. Catherine-
dc.contributor.authorBrahmer, Julie R.-
dc.date.accessioned2023-03-10T02:19:46Z-
dc.date.available2023-03-10T02:19:46Z-
dc.date.issued2021-
dc.identifier.citationJournal of Clinical Oncology, 2021, v. 39, n. 21, p. 2339-2349-
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/326507-
dc.description.abstractPURPOSE We report the first 5-year follow-up of any first-line phase III immunotherapy trial for non–small-cell lung cancer (NSCLC). KEYNOTE-024 (ClinicalTrials.gov identifier: NCT02142738) is an open-label, randomized controlled trial of pembrolizumab compared with platinum-based chemotherapy in patients with previously untreated NSCLC with a programmed death ligand-1 (PD-L1) tumor proportion score of at least 50% and no sensitizing EGFR or ALK alterations. Previous analyses showed pembrolizumab significantly improved progression-free survival and overall survival (OS). METHODS Eligible patients were randomly assigned (1:1) to pembrolizumab (200 mg once every 3 weeks for up to 35 cycles) or platinum-based chemotherapy. Patients in the chemotherapy group with progressive disease could cross over to pembrolizumab. The primary end point was progression-free survival; OS was a secondary end point. RESULTS Three hundred five patients were randomly assigned: 154 to pembrolizumab and 151 to chemotherapy. Median (range) time from randomization to data cutoff (June 1, 2020) was 59.9 (55.1-68.4) months. Among patients initially assigned to chemotherapy, 99 received subsequent anti–PD-1 or PD-L1 therapy, representing a 66.0% effective crossover rate. Median OS was 26.3 months (95% CI, 18.3 to 40.4) for pembrolizumab and 13.4 months (9.4-18.3) for chemotherapy (hazard ratio, 0.62; 95% CI, 0.48 to 0.81). Kaplan-Meier estimates of the 5-year OS rate were 31.9% for the pembrolizumab group and 16.3% for the chemotherapy group. Thirty-nine patients received 35 cycles (ie, approximately 2 years) of pembrolizumab, 82.1% of whom were still alive at data cutoff (approximately 5 years). Toxicity did not increase with longer treatment exposure. CONCLUSION Pembrolizumab provides a durable, clinically meaningful long-term OS benefit versus chemotherapy as first-line therapy for metastatic NSCLC with PD-L1 tumor proportion score of at least 50%.-
dc.languageeng-
dc.relation.ispartofJournal of Clinical Oncology-
dc.titleFive-Year Outcomes with Pembrolizumab Versus Chemotherapy for Metastatic Non–Small-Cell Lung Cancer with PD-L1 Tumor Proportion Score ‡ 50%-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1200/JCO.21.00174-
dc.identifier.pmid33872070-
dc.identifier.scopuseid_2-s2.0-85108401576-
dc.identifier.volume39-
dc.identifier.issue21-
dc.identifier.spage2339-
dc.identifier.epage2349-
dc.identifier.eissn1527-7755-
dc.identifier.isiWOS:000708089900004-

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