Highlights
– The ROME randomized phase 2 trial (NCT04591431) demonstrated a higher overall response rate (17.5% vs 10%, P=0.0294) and improved median progression-free survival (3.5 vs 2.8 months; HR 0.66, P=0.0002) for genomically matched, MTB-guided therapy (TT) versus standard of care (SoC) in patients with advanced solid tumors after 1–2 prior lines of therapy.
– TT produced superior 12-month PFS (22.0% vs 8.3%) with similar grade 3–4 adverse event rates (40% TT vs 52% SoC). Median overall survival was similar, likely confounded by a 52% crossover rate.