The Efficacy and Safety of Pembrolizumab in Advanced Melanoma: A Meta-Analysis Study

Background: Pembrolizumab, an inhibitory anti-PD-1 antibody, has led to significantly meaningful improvements in advanced melanoma. This meta-analysis discusses and presents the efficacy and safety of pembrolizumab versus control treatments in randomized controlled trials.  Methods: Electronic databases were searched systematically for RCTs using pembrolizumab in advanced melanomas. Pooled estimates were calculated under random-effect models for overall response rates, PFS, OS, and TRAEs. Results: Nine RCTs including 5132 patients were analyzed. Pembrolizumab significantly realized better results in ORR, PFS and OS HR 0.62, 95% CI 0.54, 0.71, P < 0.001 and HR 0.70, 95% CI 0.63, 0.78, P < 0.001 for control. PFS and OS were consistently better in first, second, and further lines and in groups stratified for PD-L1 status. Grade 3–5 TRAEs were lower with pembrolizumab than with chemotherapy 13.3% vs. 25.9% and ipilimumab 16.9% vs. 27.3%. Conclusions: Pembrolizumab monotherapy meaningfully improves ORRs, delays progression, and prolongs survival in advanced melanoma compared to current standard regimens, with the latter given its favorable toxicity profile. As such, pembrolizumab should be considered the new standard of care for treatment-naïve and previously treated subjects.