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Safety of Combination Immune Checkpoint Inhibitors Compared to Monotherapy; A Systematic Review and Meta-Analysis

Abstract Combination immune checkpoint inhibitors (ICIs) achieved higher efficacy than monotherapy in many types of cancers. We searched PubMed, Scopus, and Cochrane databases for randomized phase II/III trials in cancer patients receiving combination ICIs vs. Monotherapy. Our search retrieved 934 records. Eight studies were found to be eligible for meta-analysis recruiting 2544 patients. Combined immunotherapy nivolumab plus ipilimumab was associated with statistically significant higher risk of all grade adverse events (AE), and discontinuation due to all grade AEs as compared to both ipilimumab or nivolumab. Although combination ICIs showed better oncological activity, it carried a higher risk of all grade irAEs.