Sistema de Salut de Catalunya
Institut Català de la Salut
[Carbone DP] The Ohio State University Comprehensive Cancer Center and the Pelotonia Institute for Immuno-Oncology, Columbus, USA. [Ciuleanu TE] Institutul Oncologic Prof. Dr Ion Chiricuţă and University of Medicine and Pharmacy Iuliu Haţieganu, Cluj-Napoca, Romania. [Cobo M] Hospital Universitario Regional de Málaga, IBIMA Plataforma BIONAND, Málaga, Spain. [Schenker M] SF Nectarie Oncology Center, University of Medicine and Pharmacy of Craiova, Craiova, Romania. [Zurawski B] Ambulatorium Chemioterapii, Bydgoszcz, Poland. [Menezes J] Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil. [Felip E] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2025-08-11T06:18:45Z
2025-08-11T06:18:45Z
2025-06
Chemotherapy; Nivolumab; Non-small-cell lung cancer
Quimioteràpia; Nivolumab; Càncer de pulmó de cèl·lules no petites
Quimioterapia; Nivolumab; Cáncer de pulmón de células no pequeñas
Background The phase III CheckMate 9LA study demonstrated durable overall survival (OS) benefit with nivolumab plus ipilimumab with chemotherapy versus chemotherapy in patients with metastatic non-small-cell lung cancer (NSCLC). Here, we report final, 6-year efficacy and safety outcomes. Patients and methods Treatment-naive adults with stage IV/recurrent NSCLC and no sensitizing EGFR/ALK alterations were randomized to nivolumab plus ipilimumab with chemotherapy (n = 361) or chemotherapy (n = 358). Assessments included OS, progression-free survival, objective response rate, and duration of response (DOR) in all randomized patients and subgroups, and OS by select somatic mutation status (KRAS, STK11, KEAP1, and TP53). Results With 68.6 months' minimum follow-up, nivolumab plus ipilimumab with chemotherapy demonstrated continued OS benefit versus chemotherapy (hazard ratio 0.74, 95% confidence interval 0.63-0.87, 6-year OS rates 16% versus 10%), regardless of tumor programmed death ligand 1 (PD-L1) expression (PD-L1 <1%, 20% versus 7%; PD-L1 ≥1%, 15% versus 10%) and histology (squamous, 14% versus 5%; non-squamous, 17% versus 12%). The 6-year DOR rate was 19% with nivolumab plus ipilimumab with chemotherapy; all patients in the chemotherapy arm were censored or stopped responding before this timepoint. Trends toward improved OS were observed with nivolumab plus ipilimumab with chemotherapy over chemotherapy regardless of KRAS, STK11, KEAP1, or TP53 mutation status. No new safety signals were observed. Conclusions These final analyses demonstrate the durable, long-term OS and response benefit with first-line nivolumab plus ipilimumab with chemotherapy over chemotherapy in patients with metastatic NSCLC, regardless of tumor PD-L1 expression, histology, or select somatic mutation status, further supporting this regimen as a standard-of-care treatment option.
This work was supported by Bristol Myers Squibb, Princeton, NJ, USA (no grant number).
Article
Published version
English
Quimioteràpia combinada; Pulmons - Càncer - Tractament; Avaluació de resultats (Assistència sanitària); DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::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; 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; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
Elsevier
ESMO Open;10(6)
https://doi.org/10.1016/j.esmoop.2025.105123
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
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