Long-term survival with first-line nivolumab plus ipilimumab in patients with advanced non-small-cell lung cancer: A pooled analysis Journal Article


Authors: Borghaei, H.; Ciuleanu, T. E.; Lee, J. S.; Pluzanski, A.; Caro, R. B.; Gutierrez, M.; Ohe, Y.; Nishio, M.; Goldman, J.; Ready, N.; Spigel, D. R.; Ramalingam, S. S.; Paz-Ares, L. G.; Gainor, J. F.; Ahmed, S.; Reck, M.; Maio, M.; O'Byrne, K. J.; Memaj, A.; Nathan, F.; Tran, P.; Hellmann, M. D.; Brahmer, J. R.
Article Title: Long-term survival with first-line nivolumab plus ipilimumab in patients with advanced non-small-cell lung cancer: A pooled analysis
Abstract: Background: First-line nivolumab plus ipilimumab prolongs survival versus chemotherapy in advanced non-small-cell lung cancer (NSCLC). We further characterized clinical benefit with this regimen in a large pooled patient population and assessed the effect of response on survival. Patients and methods: Data were pooled from four studies of first-line nivolumab plus ipilimumab in advanced NSCLC (CheckMate 227 Part 1, 817 cohort A, 568 Part 1, and 012). Overall survival (OS), progression-free survival (PFS), objective response rate, duration of response, and safety were assessed. Landmark analyses of OS by response status at 6 months and by tumor burden reduction in responders to nivolumab plus ipilimumab were also assessed. Results: In the pooled population (N = 1332) with a minimum follow-up of 29.1-58.9 months, median OS was 18.6 months, with a 3-year OS rate of 35%; median PFS was 5.4 months (3-year PFS rate, 17%). Objective response rate was 36%; median duration of response was 23.7 months, with 38% of responders having an ongoing response at 3 years. In patients with tumor programmed death-ligand 1 (PD-L1) <1%, ≥1%, 1%-49%, or ≥50%, 3-year OS rates were 30%, 38%, 30%, and 48%. Three-year OS rates were 30% and 38% in patients with squamous or non-squamous histology. Efficacy outcomes in patients aged ≥75 years were similar to the overall pooled population (median OS, 20.1 months; 3-year OS rate, 34%). In the pooled population, responders to nivolumab plus ipilimumab at 6 months had longer post-landmark OS than those with stable or progressive disease; 3-year OS rates were 66%, 22%, and 14%, respectively. Greater depth of response was associated with prolonged survival; in patients with tumor burden reduction ≥80%, 50% to <80%, or 30% to <50%, 3-year OS rates were 85%, 72%, and 44%, respectively. No new safety signals were identified in the pooled population. Conclusion: Long-term survival benefit and durable response with nivolumab plus ipilimumab in this large patient population further support this first-line treatment option for advanced NSCLC. © 2022
Keywords: adult; cancer survival; controlled study; human tissue; aged; major clinical study; overall survival; fatigue; histopathology; advanced cancer; cancer growth; diarrhea; drug efficacy; drug safety; drug withdrawal; cancer patient; outcome assessment; follow up; antineoplastic agent; ipilimumab; cancer immunotherapy; progression free survival; multiple cycle treatment; nausea; antineoplastic combined chemotherapy protocols; carcinoma, non-small-cell lung; lung neoplasms; cohort analysis; pathology; pruritus; rash; lung tumor; population research; tumor burden; cancer size; hypothyroidism; meta analysis; programmed death 1 ligand 1; non small cell lung cancer; nsclc; progression-free survival; decreased appetite; overall response rate; squamous epithelium; first-line treatment; long term survival; nivolumab; very elderly; humans; human; male; female; article; dual immunotherapy
Journal Title: Annals of Oncology
Volume: 34
Issue: 2
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2023-02-01
Start Page: 173
End Page: 185
Language: English
DOI: 10.1016/j.annonc.2022.11.006
PUBMED: 36414192
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 1 March 2023 -- Source: Scopus
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  1. Matthew David Hellmann
    412 Hellmann