Real-World Outcomes of Nivolumab and Ipilimumab in Metastatic Melanoma as Third Line and Beyond
Menée au Danemark à partir de données en vie réelle portant sur 73 patients atteints d'un mélanome métastatique (âge médian : 57,8 ans ; durée médiane de suivi : 27,6 mois), cette étude évalue l'efficacité, du point de vue du taux de réponse globale, de la survie sans progression et de la survie globale, d'un traitement de troisième ligne ou plus combinant nivolumab et ipilimumab
Nivolumab plus ipilimumab has demonstrated activity after anti-PD-1 failure in advanced melanoma, but its effectiveness in later lines and as rechallenge remains unclear. We aimed to characterize outcomes of nivolumab/ipilimumab administered in the third line or beyond. Using the Danish Metastatic Melanoma Database (DAMMED), we identified patients with metastatic melanoma (excluding uveal melanoma) treated with nivolumab/ipilimumab after at least two prior lines of therapy, including adjuvant treatment, between 2017 and 2024. Baseline characteristics, prior treatments, and clinical outcomes were collected. Seventy-three patients were included (median age 57.8 years), of whom 47.9% had brain metastases. Most had progressed on anti-PD-1-based therapy (93.2%); 32.9% had prior exposure to anti-CTLA-4, and 84.9% had received BRAF/MEK inhibitors. Nivolumab/ipilimumab was administered as third-line therapy in 71.2%. After a median follow-up of 27.6 months, the overall response rate was 23.3% (12.5% with prior anti-CTLA-4 exposure vs. 28.6% without). Median duration of response was 19.4 months (95% CI, 14.5-NR). Median PFS was 2.7 months (95% CI, 2.4–5.7) and median OS was 9.6 months (95% CI, 6.5–20.1). In conclusion, in heavily pretreated melanoma, nivolumab/ipilimumab induces durable responses in a minority of patients, with reduced efficacy after prior anti-CTLA-4 exposure.
International Journal of Cancer , résumé, 2026