Multicenter randomized phase 2 trial of genomically matched therapy versus standard of care for previously treated advanced solid tumors

The multicenter randomized phase 2 ROME trial in Italy included 400 patients with solid metastatic cancers and progression after one or two previous line of therapy, who had mutations deemed actionable. The patients were randomized 1:1 to tailored treatment (TT) or standard of care (SOC), with possibility of crossover after progression. Objective response rate (primary endpoint) was 17.5% with TT versus 10.0% with SOC (p=0.0294). Progression-free survival, time to treatment failure, and time to next treatment also were better with TT, while overall survival was similar with 52% crossover from SOC to TT. Grade 3-4 adverse events were reported for 40% in the TT group and 52% in the SOC group. The authors conclude that these results highlight the potential of TT to improve outcomes for patients with actionable genomic alterations.