First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): Two-year update from CheckMate 9LA

Autor: Phuong Tran, Aurella Alexandru, S. Marimuthu, Tudor-Eliade Ciuleanu, Hiroshi Sakai, Manuel Cobo, Luis Paz-Ares, Michael Schenker, Jaafar Bennouna, Arnaud Scherpereel, Arteid Memaj, Enriqueta Felip, O. Juan-Vidal, David P. Carbone, B. Zurawski, Thomas John, Eduardo Richardet, Juliana Janoski de Menezes, Shun Lu, Martin Reck
Přispěvatelé: German Center for Lung Research, Institutul oncologic Prof Dr Ion Chiricuta [Cluj-Napoca, Romania], Instituto de Investigación Biomédica [Malaga, Spain] (IBIMA), SF Nectarie Oncology Center [Craiova, Romania], Ambulatorium Chemioterapii [Bydgoszcz, Poland] (AC), Hospital Nossa Senhora Da Conceição [Porto Alegre, Brazil] (HNSDC), Instituto Oncológico De Córdoba [Córdoba, Argentina] (IODC), Immunogenic Cell Death and Mesothelioma Therapy (CRCINA-ÉQUIPE 4), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Vall d'Hebron University Hospital [Barcelona], Hospital Universitari i Politècnic La Fe = University and Polytechnic Hospital La Fe, Oncology Institute of Bucharest Professor Doctor Alexandru Trestioreanu [Bucharest, Romania] (OIB), Saitama Cancer Center [Saitama, Japan] (S2C), Thérapies Laser Assistées par l'Image pour l'Oncologie - U 1189 (ONCO-THAI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Shanghai Jiaotong University, Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Ohio State University [Columbus] (OSU), Bristol-Myers Squibb [Princeton], Bristol Myers Squibb [Springfield, PA, USA] (BMS), Austin Hospital [Melbourne], Austin Health, Bernardo, Elizabeth
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Journal of Clinical Oncology
Journal of Clinical Oncology, 2021, 39 (15_suppl), pp.9000-9000. ⟨10.1200/JCO.2021.39.15_suppl.9000⟩
ISSN: 0732-183X
1527-7755
Popis: 9000 Background: In the randomized phase 3 CheckMate 9LA trial (NCT03215706), first-line NIVO + IPI combined with 2 cycles of chemo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) vs chemo alone (4 cycles). Clinical benefit was observed regardless of programmed death ligand 1 (PD-L1) expression level and histology. Here we report data with 2 years’ minimum follow-up from this study. Methods: Adult patients (pts) with stage IV / recurrent NSCLC, ECOG performance status ≤ 1, and no known sensitizing EGFR/ALK alterations were stratified by PD-L1 (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous) and were randomized 1:1 to NIVO 360 mg Q3W + IPI 1 mg/kg Q6W + chemo (2 cycles; n = 361) or chemo alone (4 cycles; n = 358). Pts with non-squamous NSCLC in the chemo-alone arm could receive pemetrexed maintenance. The primary endpoint was OS. Secondary endpoints included PFS and ORR by blinded independent central review, and efficacy by different PD-L1 levels. Safety was exploratory. Results: At a minimum follow-up of 24.4 months for OS (database lock: Feb 18, 2021), pts treated with NIVO + IPI + chemo continued to derive OS benefit vs chemo, with a median OS of 15.8 months vs 11.0 months, respectively (HR, 0.72 [95% CI, 0.61–0.86]); 2-year OS rates were 38% vs 26%. Median PFS with NIVO + IPI + chemo vs chemo was 6.7 months vs 5.3 months (HR, 0.67 [95% CI, 0.56–0.79]); 8% and 37% of pts who had disease progression received subsequent immunotherapy, respectively. ORR was 38% with NIVO + IPI + chemo vs 25% with chemo. Similar clinical benefit with NIVO + IPI + chemo vs chemo was observed in all randomized pts and across the majority of subgroups, including by PD-L1 expression level (Table) or histology. Any grade and grade 3–4 treatment-related adverse events were reported in 92% and 48% of pts in the NIVO + IPI + chemo arm vs 88% and 38% in the chemo arm, respectively. Conclusion: With 2 years’ minimum follow-up, first-line NIVO + IPI + chemo demonstrated durable survival and benefit versus chemo in pts with advanced NSCLC; no new safety signals were identified. Clinical trial information: NCT03215706. [Table: see text]
Databáze: OpenAIRE
Externí odkaz: