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Title: First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update.
Austin Authors: Reck, M;Ciuleanu, T-E;Cobo, M;Schenker, M;Zurawski, B;Menezes, J;Richardet, E;Bennouna, J;Felip, E;Juan-Vidal, O;Alexandru, A;Sakai, H;Lingua, A;Reyes, F;Souquet, P-J;De Marchi, P;Martin, C;Pérol, M;Scherpereel, A;Lu, S;Paz-Ares, L;Carbone, D P;Memaj, A;Marimuthu, S;Zhang, X;Tran, P;John, Thomas 
Affiliation: Department of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany.
Bristol Myers Squibb, Princeton, USA
Medical Oncology
Department of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, USA
Department of Oncology, Institutul Oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca, Romania
Department of Medical Oncology, Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain
Department of Oncology, SF Nectarie Oncology Center, Craiova, Romania
Department of Clinical Oncology, Ambulatorium Chemioterapii, Bydgoszcz, Poland
Department of Oncology, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil
Department of Clinical Oncology, Instituto Oncológico de Córdoba, Córdoba, Argentina
Department of Thoracic Oncology, University Hospital of Nantes and INSERM, CRCINA, Nantes, France
Department of Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona
Department of Medical Oncology, Hospital Universitario La Fe, Valencia, Spain
Department of Oncology, Institute of Oncology Prof Dr Alexandru Trestioreanu Bucha, Bucharest, Romania
Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan
Department of Medical Oncology, Instituto Medico Rio Cuarto, SA, Córdoba, Argentina
Department of Medical Oncology, Fundación Arturo López Pérez, Santiago, Metropolitana, Chile
Department of Pneumology, Hôpital Lyon Sud, Lyon, Pierre Bénite, France
Department of Oncology, Barretos Cancer Hospital, Barretos, Brazil
Department of Thoracic Oncology, Instituto Alexander Fleming, Buenos Aires, Argentina
Department of Thoracic Oncology, Léon Bérard Cancer Center, Lyon, France
Department of Pulmonary and Thoracic Oncology, University of Lille, CHU Lille, INSERM U1189, OncoThAI, Lille, France
Department of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China
Department of Medical Oncology, Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Clinical Research Unit, Universidad Complutense & CiberOnc, Madrid, Spain
Issue Date: 1-Oct-2021 2021-10-01
Publication information: ESMO Open 2021; 6(5): 100273
Abstract: 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. Adult 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. 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. 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. With a median follow-up of 30.7 months, nivolumab plus ipilimumab with chemotherapy continued to prolong overall survival (OS) versus chemotherapy. Median OS was 15.8 versus 11.0 months [hazard ratio 0.72 (95% confidence interval 0.61-0.86)]; 2-year OS rate was 38% versus 26%. Two-year PFS rate was 20% versus 8%. ORR was 38% versus 25%, respectively; 34% versus 12% of all responses were ongoing at 2 years. Median PFS2 was 13.9 versus 8.7 months. Improved efficacy outcomes in the experimental versus control arm were observed across most subgroups, including by programmed death-ligand 1 and histology. 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. 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. 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.
DOI: 10.1016/j.esmoop.2021.100273
Journal: ESMO Open
PubMed URL: 34607285
Type: Journal Article
Subjects: NSCLC
dual immunotherapy
Appears in Collections:Journal articles

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