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

Autor: H, Borghaei, T-E, Ciuleanu, J-S, Lee, A, Pluzanski, R, Bernabe Caro, M, Gutierrez, Y, Ohe, M, Nishio, J, Goldman, N, Ready, D R, Spigel, S S, Ramalingam, L G, Paz-Ares, J F, Gainor, S, Ahmed, M, Reck, M, Maio, K J, O'Byrne, A, Memaj, F, Nathan, P, Tran, M D, Hellmann, J R, Brahmer
Rok vydání: 2023
Předmět:
Zdroj: Annals of Oncology. 34:173-185
ISSN: 0923-7534
DOI: 10.1016/j.annonc.2022.11.006
Popis: First-line nivolumab plus ipilimumab prolongs survival versus chemotherapy in advanced NSCLC. We further characterized clinical benefit with this regimen in a large pooled patient population and assessed the effect of response on survival.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). OS, PFS, ORR, DOR, 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.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%). ORR was 36%; median DOR was 23.7 months, with 38% of responders having an ongoing response at 3 years. In patients with tumor PD-L11%, ≥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%, 50-80%, or 30-50%, 3-year OS rates were 85%, 72%, and 44%, respectively. No new safety signals were identified in the pooled population.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.
Databáze: OpenAIRE