Neoadjuvant ipilimumab plus nivolumab in locally advanced melanoma: A real-world single-centre retrospective study

Abstract

BackgroundNeoadjuvant immune-checkpoint inhibition (neoICI) with ipilimumab and nivolumab has shown high pathologic response rates as well as a long-lasting relapse-free survival in stage III melanoma patients. However, safety and efficacy data from real-world patients is very limited. MethodsStage IIIB-IV (M1a) melanoma patients with macroscopic nodal metastases with or without synchronous non-nodal lesions received combined neoICI with ipilimumab 1 mg/kg and nivolumab 3 mg/kg. Radiological and pathological response as well as relapse-free survival (RFS), event-free survival (EFS), overall survival (OS), melanoma-specific survival (MSS), adverse events (AE) related to neoICI and subsequent therapies were analysed. ResultsBetween November 2018 and October 2021, 23 patients received a combined neoICI. A pathologic response was achieved in 65% (15/23) of the patients, with 43% (10/23) achieving a pathological complete response. At a median follow-up of 22.8 months, median RFS, EFS, OS and MSS have not been reached. At a 3-year landmark, the RFS, EFS, OS and MSS rates were 77.6% (95% CI 60.1–100), 61.8% (95% CI 43.8–87.1), 62.0% (95% CI 42.2–91.0) and 76.7% (95% CI 55.7–100), respectively. Regarding AE, 70% (16/23) had immune-related AE (irAEs) of any grade which were classified as severe (≥ grade 3) irAEs in 13% (3/23) of patients. ConclusionThe combined neoICI with ipilimumab 1 mg/kg and nivolumab 3 mg/kg showed high response rates as well as long lasting relapse-free survival. Besides a promising efficacy, neoICI was well tolerated in our real-world patient cohort with only few high-grade irAEs indicating feasibility of neoICI in a non-trial setting.