Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50.
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ICR Authors
Authors
Reck, M
Rodríguez-Abreu, D
Robinson, AG
Hui, R
Csőszi, T
Fülöp, A
Gottfried, M
Peled, N
Tafreshi, A
Cuffe, S
O'Brien, M
Rao, S
Hotta, K
Leal, TA
Riess, JW
Jensen, E
Zhao, B
Pietanza, MC
Brahmer, JR
Rodríguez-Abreu, D
Robinson, AG
Hui, R
Csőszi, T
Fülöp, A
Gottfried, M
Peled, N
Tafreshi, A
Cuffe, S
O'Brien, M
Rao, S
Hotta, K
Leal, TA
Riess, JW
Jensen, E
Zhao, B
Pietanza, MC
Brahmer, JR
Document Type
Journal Article
Date
2021-04-19
Date Accepted
2021-04-19
Date Available
2021-07-09T13:39:17Z
Abstract
Purpose 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).Methods 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.Results 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, 18.3-40.4) for pembrolizumab and 13.4 months (9.4-18.3) for chemotherapy (hazard ratio, 0.62; 95% CI, 0.48-0.81). 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.Conclusion 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%.
Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021, pp. JCO2100174 - ?
Source Title
Publisher
ISSN
0732-183X
eISSN
1527-7755
Collections
Research Team
Treatment of thoracic tumours
Treatment of thoracic tumours
Treatment of thoracic tumours