Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ? 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study

Basit Öğe Kaydı
dc.authoridPark, Keunchil/0000-0002-4846-7449
dc.authoridCicin, Irfan/0000-0002-7584-3868
dc.authoridRodriguez-Abreu, Delvys/0000-0003-0506-1366
dc.authoridLee, Dae Ho/0000-0002-9749-4638
dc.authoridYumuk, Perran Fulden/0000-0001-8650-299X
dc.authoridBoyer, Michael/0000-0002-0452-2987
dc.authoridPiperdi, Bilal/0000-0002-1315-3175
dc.authorwosidSendur, Mehmet Ali Nahit/H-7555-2014
dc.authorwosidPark, Keunchil/ABD-7072-2021
dc.authorwosidPark, Keunchil/ABD-5852-2021
dc.authorwosidYumuk, Perran Fulden/A-6189-2018
dc.contributor.authorBoyer, Michael
dc.contributor.authorSendur, Mehmet A. N.
dc.contributor.authorRodriguez-Abreu, Delvys
dc.contributor.authorPark, Keunchil
dc.contributor.authorLee, Dae Ho
dc.contributor.authorCicin, Irfan
dc.contributor.authorYumuk, Perran Fulden
dc.date.accessioned2024-06-12T11:17:52Z
dc.date.available2024-06-12T11:17:52Z
dc.date.issued2021
dc.departmentTrakya Üniversitesien_US
dc.description.abstractPURPOSE Pembrolizumab monotherapy is standard first-line therapy for metastatic non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1) tumor proportion score (TPS) >= 50% without actionable driver mutations. It is not known whether adding ipilimumab to pembrolizumab improves efficacy over pembrolizumab alone in this population. METHODS In the randomized, double-blind, phase III KEYNOTE-598 trial (ClinicalTrials.gov identifier: ), eligible patients with previously untreated metastatic NSCLC with PD-L1 TPS >= 50% and no sensitizing EGFR or ALK aberrations were randomly allocated 1:1 to ipilimumab 1 mg/kg or placebo every 6 weeks for up to 18 doses; all participants received pembrolizumab 200 mg every 3 weeks for up to 35 doses. Primary end points were overall survival and progression-free survival. RESULTS Of the 568 participants, 284 were randomly allocated to each group. Median overall survival was 21.4 months for pembrolizumab-ipilimumab versus 21.9 months for pembrolizumab-placebo (hazard ratio, 1.08; 95% CI, 0.85 to 1.37; P = .74). Median progression-free survival was 8.2 months for pembrolizumab-ipilimumab versus 8.4 months for pembrolizumab-placebo (hazard ratio, 1.06; 95% CI, 0.86 to 1.30; P = .72). Grade 3-5 adverse events occurred in 62.4% of pembrolizumab-ipilimumab recipients versus 50.2% of pembrolizumab-placebo recipients and led to death in 13.1% versus 7.5%. The external data and safety monitoring committee recommended that the study be stopped for futility and that participants discontinue ipilimumab and placebo. CONCLUSION Adding ipilimumab to pembrolizumab does not improve efficacy and is associated with greater toxicity than pembrolizumab monotherapy as first-line treatment for metastatic NSCLC with PD-L1 TPS >= 50% and no targetable EGFR or ALK aberrations. These data do not support use of pembrolizumab-ipilimumab in place of pembrolizumab monotherapy in this population. (C) 2021 by American Society of Clinical Oncologyen_US
dc.description.sponsorshipMerck Sharp Dohme Corpen_US
dc.description.sponsorshipSupported by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, NJ.en_US
dc.identifier.doi10.1200/JCO.20.03579
dc.identifier.endpage+en_US
dc.identifier.issn0732-183X
dc.identifier.issn1527-7755
dc.identifier.issue21en_US
dc.identifier.pmid33513313en_US
dc.identifier.scopus2-s2.0-85112125078en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage2327en_US
dc.identifier.urihttps://doi.org/10.1200/JCO.20.03579
dc.identifier.urihttps://hdl.handle.net/20.500.14551/24877
dc.identifier.volume39en_US
dc.identifier.wosWOS:000708089900003en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherLippincott Williams & Wilkinsen_US
dc.relation.ispartofJournal Of Clinical Oncologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectCombined Nivolumaben_US
dc.subjectResponse Criteriaen_US
dc.subjectChemotherapyen_US
dc.subjectSurvivalen_US
dc.titlePembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ? 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Studyen_US
dc.typeArticleen_US

Dosyalar

Koleksiyon

WoS İndeksli Yayınlar Koleksiyonu
PubMed İndeksli Yayınlar Koleksiyonu
Scopus İndeksli Yayınlar Koleksiyonu