Journal: Nature medicine
The ROME trial was a multicenter, randomized phase 2 study comparing tailored treatment (TT) based on comprehensive genomic profiling with standard of care (SoC) in patients with advanced solid tumors who had one or two prior therapies.
Among 400 randomized patients, TT showed:
- Higher overall response rate: 17.5% vs. 10%
- Longer median progression-free survival: 3.5 vs. 2.8 months (HR 0.66)
- Better 12-month progression-free survival rates: 22.0% vs. 8.3%
Overall survival was similar between groups, likely due to a 52% crossover rate. Grade 3/4 adverse events were comparable.
These results support the clinical benefit of a tumor-agnostic precision oncology approach guided by genomic profiling and molecular tumor board recommendations in improving outcomes for patients with advanced solid tumors harboring actionable alterations.