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

ESMO Open

article

M. Reck¹  T.-E. Ciuleanu²  M. Cobo³  M. Schenker⁴  B. Zurawski⁵  J. Menezes⁶  E. Richardet⁷  J. Bennouna⁸  E. Felip⁹  O. Juan-Vidal^1,10  A. Alexandru^1,11  H. Sakai^1,12  A. Lingua^1,13  F. Reyes^1,14  P.-J. Souquet^1,15  P. De Marchi^1,16  C. Martin^1,17  M. Pérol^1,18  A. Scherpereel^1,19  S. Lu^2,20  L. Paz-Ares^2,21  D.P. Carbone^2,22  A. Memaj^2,23  S. Marimuthu^2,23  X. Zhang^2,23  P. Tran^2,23  T. John^2,24 

[1] Department of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungClinic;Department of Oncology, Institutul Oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu;Department of Medical Oncology, Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria;Department of Oncology, SF Nectarie Oncology Center;Department of Clinical Oncology;Department of Oncology, Hospital Nossa Senhora da Conceição;Department of Clinical Oncology, Instituto Oncológico de Córdoba;Department of Thoracic Oncology, University Hospital of Nantes and INSERM;Department of Medical Oncology, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology;Department of Medical Oncology, Hospital Universitario La Fe;Department of Oncology, Institute of Oncology Prof Dr Alexandru Trestioreanu Bucha;Department of Thoracic Oncology, Saitama Cancer Center;Department of Medical Oncology, Instituto Medico Rio Cuarto;Department of Medical Oncology, Fundación Arturo López Pérez;Department of Pneumology, Hôpital Lyon Sud;Department of Oncology, Barretos Cancer Hospital;Department of Thoracic Oncology, Instituto Alexander Fleming;Department of Thoracic Oncology, Léon Bérard Cancer Center;Department of Pulmonary and Thoracic Oncology, University of Lille;Department of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University;Department of Medical Oncology, Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Clinical Research Unit, Universidad Complutense & CiberOnc;Department of Medical Oncology, The Ohio State University Comprehensive Cancer Center;Bristol Myers Squibb, Princeton;Department of Medical Oncology, Austin Hospital

关键词: nivolumab;    ipilimumab;    NSCLC;    first-line;    dual immunotherapy;   

DOI  :  10.1016/j.esmoop.2021.100273

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background 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.Patients and methods 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.Results 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.Conclusions 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.

【 授权许可】

CC BY|CC BY-NC-ND