Efficacy and safety data for checkpoint inhibitors in advanced melanoma under real-life conditions: A monocentric study conducted in Nice from 2010 to 2016.

ABSTRACT

BACKGROUND: Immunotherapies using anti-CTLA4 and anti-PD1 antibodies have revolutionised the management of patients with advanced melanoma. The aim of our study was to analyse the efficacy and safety of immunotherapies in patients with advanced melanoma under real-life conditions. METHODS: We conducted a monocentric, retrospective, observational study that included all patients treated with immunotherapies (ipilimumab, i.e. ipi; nivolumab, i.e. niv and pembrolizumab, i.e. pbr) for advanced melanoma with exclusion of primary mucosal or ocular melanoma. The primary endpoint was progression-free survival (PFS). RESULTS: A total of 110 patients were included. Median PFS was better in the anti-PD1 group than in the anti-CTLA4 group (3.9 months vs. 2.9 months, P=0.025). The frequency of adverse events of any grade was 53.4% with ipi, 66.7% with niv and 75% with pbr. DISCUSSION: Our study shows slightly inferior efficacy data vs. clinical trials of ipi and niv because patients were presenting more severe illness at inclusion. Nevertheless, the study argues in favour of the superiority of anti-PD1 antibodies vs. anti-CTLA4 antibodies in terms of PFS and best overall response. Moreover, our study exhibits safety data comparable to those from clinical trials except for a lower frequency with ipi. CONCLUSION: Our efficacy and safety data obtained under real-life conditions are reassuring since they are consistent with data already published.