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Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817.

Publication ,  Journal Article
Paz-Ares, LG; Ciuleanu, T-E; Pluzanski, A; Lee, J-S; Gainor, JF; Otterson, GA; Audigier-Valette, C; Ready, N; Schenker, M; Linardou, H; Lee, KH ...
Published in: J Thorac Oncol
January 2023

INTRODUCTION: We characterized the safety of first-line nivolumab plus ipilimumab (NIVO+IPI) in a large patient population with metastatic NSCLC and efficacy outcomes after NIVO+IPI discontinuation owing to treatment-related adverse events (TRAEs). METHODS: We pooled data from three first-line NIVO+IPI studies (NIVO, 3 mg/kg or 240 mg every 2 wk; IPI, 1 mg/kg every 6 wk) in metastatic NSCLC (CheckMate 227 part 1, CheckMate 817 cohort A, CheckMate 568 part 1). Safety end points included TRAEs and immune-mediated adverse events (IMAEs) in the pooled population and patients aged 75 years or older. RESULTS: In the pooled population (N = 1255), any-grade TRAEs occurred in 78% of the patients, grade 3 or 4 TRAEs in 34%, and discontinuation of any regimen component owing to TRAEs in 21%. The most frequent TRAE and IMAE were diarrhea (20%; grade 3 or 4, 2%) and rash (17%; grade 3 or 4, 3%), respectively. The most common grade 3 or 4 IMAEs were hepatitis (5%) and diarrhea/colitis and pneumonitis (4% each). Pneumonitis was the most common cause of treatment-related death (5 of 16). Safety in patients aged 75 years or older (n = 174) was generally similar to the overall population, but discontinuation of any regimen component owing to TRAEs was more common (29%). In patients discontinuing NIVO+IPI owing to TRAEs (n = 225), 3-year overall survival was 50% (95% confidence interval: 42.6-56.0), and 42% (31.2-52.4) of 130 responders remained in response 2 years after discontinuation. CONCLUSIONS: First-line NIVO+IPI was well tolerated in this large population with metastatic NSCLC and in patients aged 75 years or older. Discontinuation owing to TRAEs did not reduce long-term survival.

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Published In

J Thorac Oncol

DOI

EISSN

1556-1380

Publication Date

January 2023

Volume

18

Issue

1

Start / End Page

79 / 92

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • Nivolumab
  • Lung Neoplasms
  • Ipilimumab
  • Humans
  • Carcinoma, Non-Small-Cell Lung
  • Antineoplastic Combined Chemotherapy Protocols
  • 3211 Oncology and carcinogenesis
  • 3202 Clinical sciences
  • 1112 Oncology and Carcinogenesis
 

Citation

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Paz-Ares, L. G., Ciuleanu, T.-E., Pluzanski, A., Lee, J.-S., Gainor, J. F., Otterson, G. A., … Borghaei, H. (2023). Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817. J Thorac Oncol, 18(1), 79–92. https://doi.org/10.1016/j.jtho.2022.08.014
Paz-Ares, Luis G., Tudor-Eliade Ciuleanu, Adam Pluzanski, Jong-Seok Lee, Justin F. Gainor, Gregory A. Otterson, Clarisse Audigier-Valette, et al. “Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817.J Thorac Oncol 18, no. 1 (January 2023): 79–92. https://doi.org/10.1016/j.jtho.2022.08.014.
Paz-Ares LG, Ciuleanu T-E, Pluzanski A, Lee J-S, Gainor JF, Otterson GA, et al. Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817. J Thorac Oncol. 2023 Jan;18(1):79–92.
Paz-Ares, Luis G., et al. “Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817.J Thorac Oncol, vol. 18, no. 1, Jan. 2023, pp. 79–92. Pubmed, doi:10.1016/j.jtho.2022.08.014.
Paz-Ares LG, Ciuleanu T-E, Pluzanski A, Lee J-S, Gainor JF, Otterson GA, Audigier-Valette C, Ready N, Schenker M, Linardou H, Caro RB, Provencio M, Zurawski B, Lee KH, Kim S-W, Caserta C, Ramalingam SS, Spigel DR, Brahmer JR, Reck M, O’Byrne KJ, Girard N, Popat S, Peters S, Memaj A, Nathan F, Aanur N, Borghaei H. Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817. J Thorac Oncol. 2023 Jan;18(1):79–92.
Journal cover image

Published In

J Thorac Oncol

DOI

EISSN

1556-1380

Publication Date

January 2023

Volume

18

Issue

1

Start / End Page

79 / 92

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • Nivolumab
  • Lung Neoplasms
  • Ipilimumab
  • Humans
  • Carcinoma, Non-Small-Cell Lung
  • Antineoplastic Combined Chemotherapy Protocols
  • 3211 Oncology and carcinogenesis
  • 3202 Clinical sciences
  • 1112 Oncology and Carcinogenesis