Effectiveness and Safety of Nivolumab in Patients with Advanced Melanoma: A Multicenter, Observational Study
Menée en France dans un contexte de vie réelle à partir de données portant sur 400 patients atteints d'un mélanome de stade avancé (âge médian : 66 ans), cette étude multicentrique évalue l'efficacité, du point de vue du taux de réponse clinique et de la survie globale, et la toxicité du nivolumab en traitement de seconde ligne ou au-delà
This retrospective, observational study aimed to determine the effectiveness, safety, and patterns of use of nivolumab in patients with advanced melanoma in real‐world clinical practice in France using data from a Temporary Authorization for Use Program (ATU). Data were collected from patients with unresectable or metastatic melanoma enrolled in a French national database (Réseau pour la Recherche et l'Investigation Clinique sur le Mélanome: Ric‐Mel) and treated with nivolumab during the ATU program (September 12, 2014 to August 31, 2015). The primary objectives of the study were to evaluate the effect of patient characteristics on clinical response and overall survival (OS). Among 400 included patients (median age 66 years), the majority (83%) received nivolumab as second‐ or subsequent‐line therapy. The median durations of progression‐free survival and OS were 3.3 and 14.1 months, respectively, and 31.6% of patients achieved an objective response with a median duration of 20.1 months (range 0‐34.7). The safety profile of nivolumab was manageable and consistent with those of previous clinical trials, with an incidence of grade 3‐5 adverse events of 13.8%. The safety and effectiveness of nivolumab in patients with advanced melanoma in real‐world clinical practice in France were in line with the data reported in the phase 3 trials CheckMate 066 and 037 of nivolumab in this patient population.