Systematic review and meta-analysis: efficacy and safety of ipilimumab combined with nivolumab vs. monotherapy for the treatment of metastatic melanoma

Abstract

Introduction: Immunotherapy, together with Ipilimumab and nivolumab are among the most widely used treatment options for metastatic melanoma involvement. This study compares the efficacy and safety of the combination of ipilimumab with nivolumab versus nivolumab or ipilimumab monotherapy for treating metastatic melanoma. Methods: A systematic review was conducted by extracting information from publications from different databases. Five articles were included in the review. Progression-free survival (PFS), overall survival (OS), partial response (PR), complete response (CR), objective response rate (ORR), and adverse events (AEs) of any grade and grade 3-4 were estimated. Results: We found superiority of combination therapy vs. ipilimumab in terms of PFS (HR 0·41, 95% CI [0·35, 0·49]), OS (HR 0·64, 95% CI [0·54, 0·77]), PR (RR 2·82, 95% CI [2·09, 3·81]), CR (RR 5·69, 95% CI [1·24, 26·04]) and ORR (RR 3·58, 95% CI [2·10, 6·11]); between combination therapy and nivolumab there was no statistically significant difference. An increased risk of grade 3-4 AEs was also found for combination therapy versus ipilimumab (RR 2·24, 95% CI [1·84, 2·72]) and nivolumab (RR 2·71, 95% CI [2·22, 3·31]); there was no statistically significant difference for AEs of any grade between combination therapy and monotherapy. The adverse events with the greatest strength of association were increased ALT (RR 4·23), increased AST (RR 3·74), and fever (RR 2·67). Conclusions: This meta-analysis shows that nivolumab monotherapy is the best option for the treatment of metastatic melanoma. This study was done with own financing.