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First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817 Ready, Neal Audigier-Valette, Clarisse Goldman, Jonathan W. Ciuleanu, Tudor Garcia Campelo, Rosario Felip Font, Enriqueta Institut Català de la Salut [Ready NE] Department of Medicine, Duke University, Durham, North Carolina, USA. [Audigier-Valette C] Division of Pneumo-Oncology, Hôpital Sainte Musse, Toulon, Provence-Alpes-Côte d'Azur, France. [Goldman JW] Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA. [Felip E] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Ciuleanu TE] Department of Oncology, Oncology Institute Prof Dr Ion Chiricuta, Cluj-Napoca, Romania. University of Medicine and Pharmacy Iuliu Hațieganu, Cluj-Napoca, Romania. [Rosario García Campelo M] Medical Oncology Unit, University Hospital A Coruña (XXIAC-SERGAS), A Coruña, Spain Vall d'Hebron Barcelona Hospital Campus Pulmons - Càncer - Tractament Quimioteràpia combinada Avaluació de resultats (Assistència sanitària) DISEASES::Respiratory Tract Diseases::Lung Diseases::Lung Neoplasms::Carcinoma, Bronchogenic::Respiratory Tract Diseases::Carcinoma, Non-Small-Cell Lung Other subheadings::Other subheadings::Other subheadings::/drug therapy ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols Other subheadings::Other subheadings::/therapeutic use ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada Otros calificadores::Otros calificadores::/uso terapéutico TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento Antigen CTLA-4; Immunoteràpia; Neoplàsies pulmonars Antígeno CTLA-4; Inmunoterapia; Neoplasias Pulmonares CTLA-4 antigen; Immunotherapy; Lung Neoplasms Background CheckMate 817, a phase 3B study, evaluated flat-dose nivolumab plus weight-based ipilimumab in patients with metastatic non-small cell lung cancer (NSCLC). Here, in this research, we report on first-line treatment in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0–1 (cohort A) and special populations (cohort A1: ECOG PS 2; or ECOG PS 0–1 with untreated brain metastases, renal impairment, hepatic impairment, or controlled HIV infection). Methods Cohorts A and A1 received nivolumab 240 mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks. The primary endpoint was the incidence of grade 3–4 and grade 5 immune-mediated adverse events (IMAEs; adverse events (AEs) deemed potentially immune-related, occurring <100 days of last dose, and treated with immune-modulating medication (except endocrine events)) and treatment-related select AEs (treatment-related AEs with potential immunological etiology requiring frequent monitoring/intervention, reported between first dose and 30 days after the last dose) in cohort A; efficacy endpoints were secondary/exploratory. In cohort A1, safety/efficacy assessment was exploratory. Results The most common grade 3–4 IMAEs were pneumonitis (5.1%), diarrhea/colitis (4.9%), and hepatitis (4.6%) in cohort A (N=391) and diarrhea/colitis (3.5%), hepatitis (3.5%), and rash (3.0%) in cohort A1 (N=198). The most common grade 3–4 treatment-related select AEs were hepatic (5.9%), gastrointestinal (4.9%), and pulmonary (4.6%) events in cohort A and gastrointestinal (4.0%), skin (3.5%), and endocrine (3.0%) events in cohort A1. No grade 5 IMAEs or treatment-related select AEs occurred. Treatment-related deaths occurred in 4 (1.0%) and 3 (1.5%) patients in cohorts A and A1, respectively. Three-year overall survival (OS) rates were 33.7% and 20.5%, respectively. Conclusions Flat-dose nivolumab plus weight-based ipilimumab was associated with manageable safety and durable efficacy in cohort A, consistent with data from phase 3 metastatic NSCLC studies. Special populations of cohort A1 including patients with ECOG PS 2 or ECOG PS 0–1 with untreated brain metastases had manageable treatment-related toxicity and clinically meaningful 3-year OS rate. This work was supported by Bristol Myers Squibb (Princeton, New Jersey, USA). 2023-03-03T13:29:40Z 2023-03-03T13:29:40Z 2023-02 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Ready NE, Audigier-Valette C, Goldman JW, Felip E, Ciuleanu TE, García Campelo MR, et al. First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817. J Immunother Cancer. 2023 Feb;11(2):e006127. 2051-1426 https://hdl.handle.net/11351/9107 10.1136/jitc-2022-006127 36725084 eng Journal for ImmunoTherapy of Cancer;11(2) http://dx.doi.org/10.1136/jitc-2022-006127 Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess application/pdf BMJ Scientia