The phase II ROME trial, presented at the AACR Annual Meeting 2025, involved 1,794 adult patients with advanced or metastatic solid tumors, focusing on those receiving second or third line treatments.

Results from the trial indicated that patients treated with therapies tailored based on genomic alterations detected in both tissue and liquid biopsies experienced significantly better survival outcomes compared to those receiving standard care or therapies based on either biopsy type alone.

Patients in the tailored therapy group, utilizing both tissue and liquid biopsies, achieved a median overall survival of 11.05 months, compared to 7.7 months for those receiving standard care, reflecting a 26% reduction in death risk.

The 12-month overall survival and progression-free survival rates were also higher in the tailored therapy group, at 47.8% and 27.2%, respectively, compared to 38.8% and 9.1% for standard care.

Moreover, the median progression-free survival for the tailored therapy group was 4.93 months, a notable improvement over the 2.8 months seen in the standard care group, indicating a 45% reduction in disease progression risk.

In the trial, genomic profiling using both tissue (FoundationOne CDx) and liquid biopsies (FoundationOne Liquid CDx) identified actionable alterations in 400 patients, with 49.2% showing concordance between the two biopsy types.

Specifically, 34.7% of cases revealed alterations detected only in tissue biopsies, while 16% showed alterations unique to liquid biopsies, underscoring that neither method alone fully captures tumor complexity.

The study found that discordances in biopsy results were primarily due to discrepancies in detecting molecular alterations, which accounted for 43.3% of the differences, highlighting the need for improved detection strategies.

This research emphasizes the critical role of molecular diagnostics in oncology, suggesting that pharmacists should work closely with oncologists and tumor boards to interpret genomic data and optimize therapy selection.

Looking ahead, the ROME investigators plan to validate these findings in future studies, which may lead to more adaptive approaches in precision oncology.

Despite the promising results, the trial's exploratory nature and the timing of biopsy sample collection were noted as limitations that warrant further investigation.

The trial also highlighted the advantages and limitations of both biopsy methods, with tissue biopsies providing direct tumor samples but being invasive, while liquid biopsies are less invasive but may miss alterations in tumors that do not shed enough cells into the bloodstream.