TY - JOUR
T1 - Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab–Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%
T2 - A Pooled Analysis
AU - Peters, Solange
AU - Paz-Ares, Luis G
AU - Reck, Martin
AU - Carbone, David P
AU - Brahmer, Julie R
AU - Borghaei, Hossein
AU - Lu, Shun
AU - O'Byrne, Kenneth J
AU - John, Thomas
AU - Ciuleanu, Tudor-Eliade
AU - Schenker, Michael
AU - Caro, Reyes Bernabe
AU - Nishio, Makoto
AU - Cobo, Manuel
AU - Lee, Jong-Seok
AU - Zurawski, Bogdan
AU - Pluzanski, Adam
AU - Aoyama, Takekazu
AU - Tschaika, Marina
AU - Devas, Vipul
AU - Grootendorst, Diederik J
AU - Ramalingam, Suresh S
N1 - Copyright © 2024 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
PY - 2025/1
Y1 - 2025/1
N2 - INTRODUCTION: Nivolumab plus ipilimumab-based treatment regimens have shown long-term, durable efficacy benefits in patients with metastatic NSCLC. Here we report clinical outcomes from a pooled analysis of patients with metastatic NSCLC and tumor programmed death-ligand 1 (PD-L1) lower than 1% treated with first-line nivolumab plus ipilimumab with or without two cycles of chemotherapy versus up to four cycles of chemotherapy in the randomized phase 3 CheckMate 227 and CheckMate 9LA studies.METHODS: Patients were aged 18 years or older and had stage IV or recurrent NSCLC with no sensitizing EGFR/ALK alterations. Assessments included overall survival (OS), progression-free survival (PFS), objective response rate, duration of response, and safety.RESULTS: In patients with tumor PD-L1 lower than 1% in the nivolumab plus ipilimumab with or without chemotherapy (n = 322) versus chemotherapy (n = 315) arms, median OS was 17.4 versus 11.3 months, respectively, (hazard ratio [HR] = 0.64, 95% confidence interval [CI]: 0.54-0.76; 5-y OS rate, 20% versus 7%) at a median follow-up of 73.7 months. The OS benefit was observed across key subgroups, including difficult-to-treat populations such as those with baseline brain metastases (HR = 0.44, 95% CI: 0.26-0.75) or squamous NSCLC (HR = 0.51, 95% CI: 0.36-0.72). In the overall pooled population, the median PFS was 5.4 versus 4.9 months (HR = 0.72, 95% CI: 0.60-0.87; 5-y PFS rate, 9% versus 2%), the objective response rate was 29% versus 22%, and the median duration of response was 18.0 versus 4.6 months. No new safety signals were observed.CONCLUSION: Nivolumab plus ipilimumab with or without chemotherapy provides a long-term, durable clinical benefit in patients with metastatic NSCLC and tumor PD-L1 lower than 1%, supporting the use of this strategy as a first-line treatment option in this population with high unmet need.CLINICAL TRIAL REGISTRATIONS: NCT02477826, NCT03215706.
AB - INTRODUCTION: Nivolumab plus ipilimumab-based treatment regimens have shown long-term, durable efficacy benefits in patients with metastatic NSCLC. Here we report clinical outcomes from a pooled analysis of patients with metastatic NSCLC and tumor programmed death-ligand 1 (PD-L1) lower than 1% treated with first-line nivolumab plus ipilimumab with or without two cycles of chemotherapy versus up to four cycles of chemotherapy in the randomized phase 3 CheckMate 227 and CheckMate 9LA studies.METHODS: Patients were aged 18 years or older and had stage IV or recurrent NSCLC with no sensitizing EGFR/ALK alterations. Assessments included overall survival (OS), progression-free survival (PFS), objective response rate, duration of response, and safety.RESULTS: In patients with tumor PD-L1 lower than 1% in the nivolumab plus ipilimumab with or without chemotherapy (n = 322) versus chemotherapy (n = 315) arms, median OS was 17.4 versus 11.3 months, respectively, (hazard ratio [HR] = 0.64, 95% confidence interval [CI]: 0.54-0.76; 5-y OS rate, 20% versus 7%) at a median follow-up of 73.7 months. The OS benefit was observed across key subgroups, including difficult-to-treat populations such as those with baseline brain metastases (HR = 0.44, 95% CI: 0.26-0.75) or squamous NSCLC (HR = 0.51, 95% CI: 0.36-0.72). In the overall pooled population, the median PFS was 5.4 versus 4.9 months (HR = 0.72, 95% CI: 0.60-0.87; 5-y PFS rate, 9% versus 2%), the objective response rate was 29% versus 22%, and the median duration of response was 18.0 versus 4.6 months. No new safety signals were observed.CONCLUSION: Nivolumab plus ipilimumab with or without chemotherapy provides a long-term, durable clinical benefit in patients with metastatic NSCLC and tumor PD-L1 lower than 1%, supporting the use of this strategy as a first-line treatment option in this population with high unmet need.CLINICAL TRIAL REGISTRATIONS: NCT02477826, NCT03215706.
KW - Immunotherapy
KW - Ipilimumab
KW - Nivolumab
KW - Non–small cell lung cancer
KW - PD-L1
KW - Humans
KW - Middle Aged
KW - Male
KW - Survival Rate
KW - Nivolumab/therapeutic use
KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
KW - Ipilimumab/administration & dosage
KW - Lung Neoplasms/drug therapy
KW - B7-H1 Antigen/antagonists & inhibitors
KW - Carcinoma, Non-Small-Cell Lung/drug therapy
KW - Aged, 80 and over
KW - Female
KW - Adult
KW - Aged
UR - http://www.scopus.com/inward/record.url?scp=85208360083&partnerID=8YFLogxK
U2 - 10.1016/j.jtho.2024.09.1439
DO - 10.1016/j.jtho.2024.09.1439
M3 - Article
C2 - 39369790
SN - 1556-0864
VL - 20
SP - 94
EP - 108
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 1
ER -
