Multicenter phase 2 trial of BO-112 plus pembrolizumab for anti-PD-1-resistant advanced melanoma

BO-112 is a synthetic double-stranded RNA nanoplexed with polyethylemeinine that when administered intratumorally mimics a viral infection and can mobilize the immune system. The phase 2 SPOTlIGHT-203 in Spain and France evaluated the combination of BO-112 plus pembrolizumab for anti-PD-1-resistant advanced melanoma. The objective response rate was 25% and the disease control rate was 67%, with duration of response not reached. The median progression-free survival was 3.7 months, and the median overall survival was not reached. The combination was well tolerated. The authors conclude that the combination of BO-112 and pembrolizumab demonstrated promising activity among patients with anti-PD-1-resistant advanced melanoma.