Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non–Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50%
-
- Martin Reck
- Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Grosshansdorf, Germany
-
- Delvys Rodríguez-Abreu
- Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas, Spain
-
- Andrew G. Robinson
- Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, ON, Canada
-
- Rina Hui
- Westmead Hospital and the University of Sydney, Sydney, NSW, Australia
-
- Tibor Csőszi
- Jász-Nagykun-Szolnok County Hospital, Szolnok, Hungary
-
- Andrea Fülöp
- Országos Korányi Pulmonológiai Intézet, Budapest, Hungary
-
- Maya Gottfried
- Meir Medical Center, Kfar-Saba, Israel
-
- Nir Peled
- Soroka Cancer Center, Ben Gurion University, Beer Sheva, Israel
-
- Ali Tafreshi
- Wollongong Private Hospital and University of Wollongong, Wollongong, NSW, Australia
-
- Sinead Cuffe
- St James's Hospital and Cancer Trials Ireland (formerly ICORG—All Ireland Cooperative Oncology Research Group), Dublin, Ireland
-
- Mary O'Brien
- The Royal Marsden Hospital, Sutton, Surrey, UK
-
- Suman Rao
- MedStar Franklin Square Hospital, Baltimore, MD
-
- Katsuyuki Hotta
- Okayama University Hospital, Okayama, Japan
-
- Ticiana A. Leal
- Carbone Cancer Center, University of Wisconsin, Madison, WI
-
- Jonathan W. Riess
- UC Davis Comprehensive Cancer Center, Sacramento, CA
-
- Erin Jensen
- Merck & Co, Inc, Kenilworth, NJ
-
- Bin Zhao
- Merck & Co, Inc, Kenilworth, NJ
-
- M. Catherine Pietanza
- Merck & Co, Inc, Kenilworth, NJ
-
- Julie R. Brahmer
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
抄録
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> 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). </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> 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%. </jats:p></jats:sec>
収録刊行物
-
- Journal of Clinical Oncology
-
Journal of Clinical Oncology 39 (21), 2339-2349, 2021-07-20
American Society of Clinical Oncology (ASCO)