Safety included timing and management of immune-mediated adverse events (AEs). We report results with minimum 4 years' follow-up.Īdults with previously untreated stage IV or recurrent NSCLC were randomized (1:1:1) to nivolumab plus ipilimumab, nivolumab, or chemotherapy (PD-L1 ≥1%) or to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (PD-L1 <1%). In CheckMate 227, nivolumab plus ipilimumab prolonged overall survival (OS) versus chemotherapy in patients with tumor programmed death-ligand 1 (PD-L1) greater than or equal to 1% (primary end point) or less than 1% (prespecified descriptive analysis). 36 Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany.35 Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland.34 Bristol Myers Squibb, Princeton, New Jersey.33 Memorial Sloan Kettering Cancer Center, New York, New York.32 Queensland University of Technology, Princess Alexandra Hospital, Brisbane, Australia.31 Fox Chase Cancer Center, Philadelphia, Pennsylvania.30 Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.29 St John of God Hospital Murdoch, Perth, Australia.28 ICO Rene Gauducheau, St Herblain, France.27 Limoges University Hospital, Limoges, France.Alexandru Trestioreanu" Bucha, Bucharest, Romania. 25 Ambulatorium Chemioterapii, Bydgoszcz, Poland.Nectarie Oncology Center, Craiova, Romania. 23 The Ohio State University, Columbus, Ohio.22 Catalan Institute of Oncology-Germans Trias i Pujol Hospital, B-ARGO group, Badalona, Spain.Puerta De Hierro-IDIPHIM, Universidad Autónoma de Madrid, Madrid, Spain. 19 Chungbuk National University Hospital, Cheongju-si, Republic of Korea.18 Hospital Italiano De Buenos Aires, Buenos Aires, Argentina.17 Metropolitan Hospital, Neo Faliro, Greece.16 Kindai University Faculty of Medicine, Osaka, Japan.15 Fundacion Arturo Lopez Perez, Santiago, Chile.14 Cross Cancer Institute, Edmonton, Alberta, Canada.13 Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.12 Netherlands Cancer Institute, Amsterdam, The Netherlands.11 Hôpital Sainte Musse, Toulon, France.10 Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.9 National Cancer Center Hospital, Tokyo, Japan.8 Saitama Cancer Center, Saitama, Japan.7 Samsung Medical Center at Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.6 Hospital Universitario Virgen Del Rocio, Instituto de Biomedicina de Seville, Seville, Spain.5 Matrai Gyogyintezet, Matrahaza, Hungary.4 Seoul National University Bundang Hospital, Seongnam, Republic of Korea.3 Institutul Oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu, Cluj Napoca, România.Electronic address: 2 Winship Cancer Institute, Emory University, Atlanta, Georgia. 1 Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit, Universidad Complutense & CiberOnc, Madrid, Spain.Additionally, 25% of patients receiving the combination discontinued due to toxic effects compared to 15% in receiving nivolumab only. 39.5% of patients who received the combination had a grade 3 or higher treatment-related events compared to 33.3% in the nivolumab. The combination had a median response duration of 28.4 months (95% CI, 4.9 months to not reached) compared to 9.7 months (95% CI, 4.2-23.1 months) for nivolumab alone. Median investigator assessed progression-free survival was 3.8 months (95% CI, 1.8-4.0 months) for the combination and 2.9 months (95% CI, 1.8-4.0 months) for nivolumab alone. The median survival was 10 months (95% CI, 8.0-14.4 months) for the nivolumab-ipilimumab combination and 11 months (95% CI, 8.6-13.7 months) for nivolumab alone. The primary endpoint of overall survival was not significantly different between groups (HR, 0.87 95% CI, 0.66-1.16 P = .34). The median follow-up in surviving patients in both groups was 29.5 months (95% CI, 26.0-32.8 months). 252 patients enrolled in the Phase 3 trial from 58 institutions in the US through the National Clinical Trial network and were randomized 1:1 to nivolumab or the combination of nivolumab-ipilimumab.
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