Portal de Periódicos da CAPES

Artigo Produção Nacional Revisado por pares

BIBTEX RIS

First-line (1L) nivolumab (N) + ipilimumab (I) + chemotherapy (C) vs C alone in patients (pts) with metastatic NSCLC (mNSCLC) from CheckMate 9LA: 4-y clinical update and outcomes by tumor histologic subtype (THS).

2023; Lippincott Williams & Wilkins; Volume: 41; Issue: 17_suppl Linguagem: Inglês

10.1200/jco.2023.41.17_suppl.lba9023

1527-7755

David P. Carbone, Tudor‐Eliade Ciuleanu, Michael Schenker, Manuel Cobo, Stéphanie Bordenave-Juchereau, Óscar Juan, J. Menezes, Niels Reinmuth, Eduardo Richardet, Ying Cheng, Hideaki Mizutani, Luis Paz‐Ares, Shun Lu, Thomas John, Xiaoqing Zhang, Nan Hu, David Balli, Vipul Baxi, Jaclyn Neely, Martin Reck,

Lung Cancer Treatments and Mutations

LBA9023 Background: In CheckMate 9LA (NCT03215706), 1L N + I + C demonstrated durable survival benefit in pts with mNSCLC vs C alone. Here, we report updated efficacy and safety with a 4-y minimum (min) follow-up (f/u) as well as exploratory analyses of efficacy by THS, a known prognostic indicator for NSCLC. Methods: Adults with stage IV/recurrent NSCLC (no known sensitizing EGFR/ALK alterations) and ECOG PS ≤ 1 were randomized 1:1 to N 360 mg Q3W + I 1 mg/kg Q6W + 2 cycles of C (n = 361) or 4 cycles of C alone (n = 358). Pts were stratified by sex, PD-L1 (< 1% vs ≥ 1%), and histology (squamous [SQ] vs non-squamous [NSQ]). Maintenance pemetrexed was allowed in the C arm (NSQ NSCLC). Assessments included OS, PFS, ORR, safety, treatment (tx)-free interval (TFI; time from last study dose to start of first subsequent systemic tx or death), and efficacy by THS (solid, acinar, or other, per modified WHO classification). Results: At a min f/u of 47.9 mo (database lock, Feb 2023; median f/u, 54.5 mo), N + I + C continued to provide long-term, durable OS benefit vs C in all randomized pts (HR, 0.74 [95% CI 0.63–0.87]; 4-y OS rates, 21% vs 16%, respectively). Similar clinical benefit was seen for N + I + C vs C across tumor PD-L1 or histology subgroups (table). In all pts treated with N + I + C (n = 358), median TFI was 2.2 mo, with 11% remaining tx-free and alive at 4y. In pts who discontinued all components of N + I + C due to tx-related adverse events (n = 61), 4-y OS rate was 41%; median TFI was 10.6 mo, with a 4-y TFI rate of 27%. In an exploratory analysis in pts with evaluable NSQ NSCLC tissue (n = 310; min f/u 36.1 mo), median OS was longer with N + I + C vs C in both solid (16.6 vs 9.3 mo) and acinar (18.7 vs 12.9 mo) THS. Updated efficacy by THS will be presented. No new safety signals were identified with longer f/u. Conclusions: With a 4-y min f/u, pts treated with N + I + C continued to derive long-term, durable efficacy benefit vs C regardless of tumor PD-L1 expression or histology, with greater magnitude of benefit in pts with tumor PD-L1 < 1% or SQ histology. Exploratory analyses suggested OS benefit with N + I + C vs C in both solid and acinar subtypes. Together, these data further reinforce the use of N + I + C as an efficacious 1L tx option for pts with mNSCLC. Clinical trial information: NCT03215706 . [Table: see text]