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Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial.

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Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Carbone DP
  • Ciuleanu TE
  • Schenker M
  • Cobo M
  • Bordenave S
  • Menezes J
  • Reinmuth N
  • Richardet E
  • Cheng Y
  • Mizutani H
  • Felip E
  • Zurawski B
  • Alexandru A
  • Paz-Ares L
  • Lu S
  • John T
  • Zhang X
  • Mahmood J
  • Hu N
  • De T
  • Santi I
  • Penrod JR
  • Yuan Y
  • Lee A
  • Reck M

Grupos

Abstract

BACKGROUND: In CheckMate 9LA, nivolumab plus ipilimumab with chemotherapy prolonged overall survival (OS) versus chemotherapy regardless of tumor PD-L1 expression or histology. We report updated efficacy and safety in all randomized patients with a minimum 4-year follow-up and an exploratory treatment-switching adjustment analysis in all treated patients who received chemotherapy and subsequent immunotherapy. METHODS: Adults with stage IV/recurrent non-small cell lung cancer (NSCLC), no sensitizing EGFR/ALK alterations, and ECOG performance status =1 were randomized 1:1 to nivolumab 360mg every 3 weeks plus ipilimumab 1mg/kg every 6 weeks with chemotherapy (two cycles) or chemotherapy (four cycles, with optional maintenance pemetrexed for the nonsquamous population). Assessments included OS, progression-free survival, and objective response rate. Exploratory analyses included efficacy by tumor PD-L1 expression and histology and in patients who discontinued nivolumab plus ipilimumab with chemotherapy due to treatment-related adverse events (TRAEs), and a treatment-switching adjustment analysis using inverse probability of censoring weighting. RESULTS: With a 47.9-month minimum follow-up for OS, nivolumab plus ipilimumab with chemotherapy continued to prolong OS over chemotherapy in all randomized patients (HR 0.74, 95%CI 0.63 to 0.87; 4-year OS rate: 21% versus 16%), regardless of tumor PD-L1 expression (HR (95%CI): PD-L1<1%, 0.66 (0.50 to 0.86) and =1%, 0.74 (0.60 to 0.92)) or histology (squamous, 0.64 (0.48 to 0.84) and non-squamous, 0.80 (0.66 to 0.97)). In patients who discontinued all components of nivolumab plus ipilimumab with chemotherapy due to TRAEs (n=61), the 4-year OS rate was 41%. With treatment-switching adjustment for the 36% of patients receiving subsequent immunotherapy in the chemotherapy arm, the estimated HR of nivolumab plus ipilimumab with chemotherapy versus chemotherapy was 0.66 (95% CI 0.55 to 0.80). No new safety signals were observed. CONCLUSIONS: In this 4-year update, patients treated with nivolumab plus ipilimumab with chemotherapy continued to have long-term, durable efficacy benefit over chemotherapy regardless of tumor PD-L1 expression and/or histology. A greater estimated relative OS benefit was observed after adjustment for subsequent immunotherapy use in the chemotherapy arm. These results further support nivolumab plus ipilimumab with chemotherapy as a first-line treatment for patients with metastatic/recurrent NSCLC, including those with tumor PD-L1<1%or squamous histology, populations with high unmet needs.

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Datos de la publicación

ISSN/ISSNe:
2051-1426, 2051-1426

Journal for ImmunoTherapy of Cancer  BMJ PUBLISHING GROUP

Tipo:
Article
Páginas:
-
PubMed:
38346853
Factor de Impacto:
3,450 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • clinical trials, phase III as topic; drug therapy, combination; immunotherapy; non-small cell lung cancer; programmed cell death 1 receptor

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