First-Line Genomic Profiling in Previously Untreated Advanced Solid Tumors: 1-Year Follow-Up of the FIRST-Dx Study

Area of Science:

• Oncology
• Genomics
• Clinical Trials

Background:

• Advanced solid tumors lack targeted therapies in the first-line setting.
• Comprehensive genomic profiling (CGP) offers a potential strategy for precision medicine.

Purpose of the Study:

• To evaluate the clinical utility and benefits of upfront CGP testing in chemotherapy-naïve advanced solid tumors.
• To assess overall survival (OS), molecular-based recommended therapy (MBRT) uptake, response rates, and progression-free survival (PFS) ratio.

Main Methods:

• Prospective evaluation of CGP (FoundationOne CDx) in 172 patients across six Japanese hospitals.
• Interim analysis focusing on first-line treatment and subsequent therapies guided by molecular tumor board recommendations.
• Endpoints included OS, MBRT, overall response rate (ORR), and PFS ratio (PFS on MBRT/PFS on first-line therapy).

Main Results:

• Median OS was not reached; 22.7% of patients received MBRT.
• First-line ORR was higher in the MBRT group (56.3%) versus non-MBRT (42.3%).
• Second-line MBRT showed a median PFS ratio of 1.1, with 33.3% of patients achieving a ratio ≥1.3.

Conclusions:

• Upfront CGP testing in advanced solid tumors is a clinically beneficial strategy.
• CGP facilitates the selection of molecular-based recommended therapies, potentially improving patient outcomes.
• This approach supports guiding subsequent precision anticancer treatments in oncology.