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    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

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    Authors
    Boyer, M.
    Şendur, M. A. N.
    Rodríguez-Abreu, D.
    Park, K.
    Lee, D. H.
    Çiçin, I.
    Yumuk, P. F.
    Orlandi, F. J.
    Leal, T. A.
    Molinier, O.
    Soparattanapaisam, N.
    Langleben, A.
    Califano, Raffaele
    Medgyasszay, B.
    Hsia, T. C.
    Otterson, G. A.
    Xu, L.
    Piperdi, B.
    Samkari, A.
    Reck, M.
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    Affiliation
    Chris O'Brien Lifehouse, Camperdown, NSW, Australia.
    Issue Date
    2021
    
    Metadata
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    Abstract
    Purpose: 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.
    Citation
    Boyer 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.
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/623776
    DOI
    10.1200/jco.20.03579
    PubMed ID
    33513313
    Additional Links
    https://dx.doi.org/10.1200/jco.20.03579
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/jco.20.03579
    Scopus Count
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