Publication: Pembrolizumab plus Ipilimumab or Placebo for Metastatic Non–Small-Cell Lung Cancer with PDL1 Tumor Proportion Score ‡ 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study
Issued Date
2021-07-20
Resource Type
ISSN
15277755
0732183X
0732183X
Other identifier(s)
2-s2.0-85112125078
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of Clinical Oncology. Vol.39, No.21 (2021), 2327-2338
Suggested Citation
Michael Boyer, Mehmet A.N. Şendur, Delvys Rodríguez-Abreu, Keunchil Park, Dae Ho Lee, Irfan Çiçin, Perran Fulden Yumuk, Francisco J. Orlandi, Ticiana A. Leal, Olivier Molinier, Nopadol Soparattanapaisarn, Adrian Langleben, Raffaele Califano, Balazs Medgyasszay, Te Chun Hsia, Gregory A. Otterson, Lu Xu, Bilal Piperdi, Ayman Samkari, Martin Reck Pembrolizumab plus Ipilimumab or Placebo for Metastatic Non–Small-Cell Lung Cancer with PDL1 Tumor Proportion Score ‡ 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study. Journal of Clinical Oncology. Vol.39, No.21 (2021), 2327-2338. doi:10.1200/JCO.20.03579 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/76102
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Title
Pembrolizumab plus Ipilimumab or Placebo for Metastatic Non–Small-Cell Lung Cancer with PDL1 Tumor Proportion Score ‡ 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study
Author(s)
Michael Boyer
Mehmet A.N. Şendur
Delvys Rodríguez-Abreu
Keunchil Park
Dae Ho Lee
Irfan Çiçin
Perran Fulden Yumuk
Francisco J. Orlandi
Ticiana A. Leal
Olivier Molinier
Nopadol Soparattanapaisarn
Adrian Langleben
Raffaele Califano
Balazs Medgyasszay
Te Chun Hsia
Gregory A. Otterson
Lu Xu
Bilal Piperdi
Ayman Samkari
Martin Reck
Mehmet A.N. Şendur
Delvys Rodríguez-Abreu
Keunchil Park
Dae Ho Lee
Irfan Çiçin
Perran Fulden Yumuk
Francisco J. Orlandi
Ticiana A. Leal
Olivier Molinier
Nopadol Soparattanapaisarn
Adrian Langleben
Raffaele Califano
Balazs Medgyasszay
Te Chun Hsia
Gregory A. Otterson
Lu Xu
Bilal Piperdi
Ayman Samkari
Martin Reck
Other Contributor(s)
Siriraj Hospital
School of Medicine
Ankara Yildirim Beyazit University
Centre Hospitalier Le Mans
Asan Medical Center
China Medical University Hospital
Complejo Hospitalario Universitario Insular Materno-Infantil
SKKU School of Medicine
University of Wisconsin Carbone Cancer Center
Merck & Co., Inc.
Marmara Üniversitesi Tip Fakültesi
Trakya Üniversitesi
The University of Manchester
The Ohio State University Comprehensive Cancer Center
Orlandi-Oncología
Veszprém Megyei Tüdőgyógyintézet Farkasgyepű
Chris O'Brien Lifehouse
German Center for Lung Research
School of Medicine
Ankara Yildirim Beyazit University
Centre Hospitalier Le Mans
Asan Medical Center
China Medical University Hospital
Complejo Hospitalario Universitario Insular Materno-Infantil
SKKU School of Medicine
University of Wisconsin Carbone Cancer Center
Merck & Co., Inc.
Marmara Üniversitesi Tip Fakültesi
Trakya Üniversitesi
The University of Manchester
The Ohio State University Comprehensive Cancer Center
Orlandi-Oncología
Veszprém Megyei Tüdőgyógyintézet Farkasgyepű
Chris O'Brien Lifehouse
German Center for Lung Research
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 5 .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 5 .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.