Late-onset adverse events under anti-PD1 therapy in melanoma patients: an observational study from MELBASE, a nationwide prospective cohort.

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The purpose was to evaluate late-onset AEs in melanoma patients treated with anti-PD1 administered at least 2 years in a real-life setting. Patients were screened from MelBase (NCT02828202), a French multicentric biobank dedicated to the prospective follow-up of unresectable stage III or IV melanoma. 119 patients who received anti-PD1 during at least 2 years from January 2013 to November 2019 were included. Median follow-up was 41.7 months (25.2-57.5). Patients received nivolumab (n=53) or pembrolizumab (n=66). AEs occurred in 99 patients (83%) with a median time of 13.3 months (0-53.9), including severe AEs (grade 3 or 4) in 30 patients (30%). Late-onset AEs, mostly grade 1-2, occurred in 51 (43%) patients and led to 5 (4%) hospitalizations of which 4 were severe. Factors associated with late-onset AEs in multivariate analysis were early-onset AEs (within the first two years of treatment) and treatment duration (p=0,02 and p=0,03 respectively). Our data demonstrate the possibility of late-onset AEs occurring after 2 years of anti-PD1 therapy. Late-onset AEs appear frequent and mostly mild or moderate. Early-onset AEs and prolonged anti-PD1 treatment may increase the risk of late-onset AEs.

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Authors: Clémentine Carlet, Stéphane Dalle, Marie-Thérèse Leccia, Laurent Mortier, Sophie Dalac-Rat, Caroline Dutriaux, Delphine Legoupil, Henri Montaudié, Olivier Dereure, Julie De Quatrebarbes, Florence Granel-Brocard, Myrtille Le-Bouar, Julie Charles, Florence Brunet-Possenti, Brigitte Dreno, Wendy Lefevre, Clara Allayous, Céleste Lebbe, Charlée Nardin