With a 2-year minimum follow-up, nivolumab plus ipilimumab with two cycles of chemotherapy provided durable efficacy benefits over chemotherapy with a manageable safety profile and remains an efficacious first-line treatment of advanced non-small-cell lung cancer. In patients who discontinued all components of nivolumab plus ipilimumab with chemotherapy treatment due to TRAEs (n = 61) median OS was 27.5 months 56% of responders had an ongoing response ≥1 year after discontinuation. No new safety signals were observed onset of grade 3/4 TRAEs was mostly observed during the first two treatment cycles in the experimental arm.
Improved efficacy outcomes in the experimental versus control arm were observed across most subgroups, including by programmed death-ligand 1 and histology. ORR was 38% versus 25%, respectively 34% versus 12% of all responses were ongoing at 2 years. Median OS was 15.8 versus 11.0 months 2-year OS rate was 38% versus 26%. With a median follow-up of 30.7 months, nivolumab plus ipilimumab with chemotherapy continued to prolong overall survival (OS) versus chemotherapy. Updated efficacy and safety outcomes are reported, along with progression-free survival (PFS) after next line of treatment (PFS2), treatment-related adverse events (TRAEs) by treatment cycle, and efficacy outcomes in patients who discontinued all treatment components in the experimental arm due to TRAEs. Patients were randomized 1 : 1 to nivolumab 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks with two cycles of chemotherapy, or four cycles of chemotherapy.
CHECKMATE 9LA STUDY DESIGN TRIAL
To further characterize survival benefit with first-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone, we report updated data from the phase III CheckMate 9LA trial with a 2-year minimum follow-up.Īdult patients were treatment naïve, with stage IV/recurrent non-small-cell lung cancer, no known sensitizing EGFR/ALK alterations, and an Eastern Cooperative Oncology Group performance status ≤1. 24 Department of Medical Oncology, Austin Hospital, Heidelberg, Australia.23 Bristol Myers Squibb, Princeton, USA.22 Department of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, USA.21 Department of Medical Oncology, Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Clinical Research Unit, Universidad Complutense & CiberOnc, Madrid, Spain.20 Department of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.19 Department of Pulmonary and Thoracic Oncology, University of Lille, CHU Lille, INSERM U1189, OncoThAI, Lille, France.18 Department of Thoracic Oncology, Léon Bérard Cancer Center, Lyon, France.17 Department of Thoracic Oncology, Instituto Alexander Fleming, Buenos Aires, Argentina.16 Department of Oncology, Barretos Cancer Hospital, Barretos, Brazil.15 Department of Pneumology, Hôpital Lyon Sud, Lyon, Pierre Bénite, France.14 Department of Medical Oncology, Fundación Arturo López Pérez, Santiago, Metropolitana, Chile.13 Department of Medical Oncology, Instituto Medico Rio Cuarto, SA, Córdoba, Argentina.12 Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.11 Department of Oncology, Institute of Oncology Prof Dr Alexandru Trestioreanu Bucha, Bucharest, Romania.10 Department of Medical Oncology, Hospital Universitario La Fe, Valencia, Spain.9 Department of Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona.8 Department of Thoracic Oncology, University Hospital of Nantes and INSERM, CRCINA, Nantes, France.7 Department of Clinical Oncology, Instituto Oncológico de Córdoba, Córdoba, Argentina.6 Department of Oncology, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil.5 Department of Clinical Oncology, Ambulatorium Chemioterapii, Bydgoszcz, Poland.4 Department of Oncology, SF Nectarie Oncology Center, Craiova, Romania.3 Department of Medical Oncology, Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain.Electronic address: 2 Department of Oncology, Institutul Oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca, Romania. 1 Department of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany.
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