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dc.contributor.authorBoyer, M.
dc.contributor.authorŞendur, M. A. N.
dc.contributor.authorRodríguez-Abreu, D.
dc.contributor.authorPark, K.
dc.contributor.authorLee, D. H.
dc.contributor.authorÇiçin, I.
dc.contributor.authorYumuk, P. F.
dc.contributor.authorOrlandi, F. J.
dc.contributor.authorLeal, T. A.
dc.contributor.authorMolinier, O.
dc.contributor.authorSoparattanapaisam, N.
dc.contributor.authorLangleben, A.
dc.contributor.authorCalifano, Raffaele
dc.contributor.authorMedgyasszay, B.
dc.contributor.authorHsia, T. C.
dc.contributor.authorOtterson, G. A.
dc.contributor.authorXu, L.
dc.contributor.authorPiperdi, B.
dc.contributor.authorSamkari, A.
dc.contributor.authorReck, M.
dc.date.accessioned2021-03-08T06:18:44Z
dc.date.available2021-03-08T06:18:44Z
dc.date.issued2021en
dc.identifier.citationBoyer M, Sendur MAN, Rodriguez-Abreu D, Park K, Lee DH, Cicin I, et al. 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. J Clin Oncol. 2021:JCO2003579.en
dc.identifier.pmid33513313en
dc.identifier.doi10.1200/jco.20.03579en
dc.identifier.urihttp://hdl.handle.net/10541/623776
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: NCT03302234), 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.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1200/jco.20.03579en
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
dc.typeArticleen
dc.contributor.departmentChris O'Brien Lifehouse, Camperdown, NSW, Australia.en
dc.identifier.journalJournal of Clinical Oncologyen
dc.description.noteen]


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