Phase 3 trial evaluates FoundationOne CDx assay for identifying HRR-positive and BRCA-positive mCSPC patients, indicating treatment implications.
Key Points
This research aims to evaluate the effectiveness of the FoundationOne CDx assay in identifying HRR-positive and BRCA-positive patients with metastatic castration-resistant prostate cancer (mCSPC).
Conducted a phase 3, randomized, double-blind, placebo-controlled trial (AMPLITUDE)
Evaluated HRR status using the FoundationOne CDx assay and other tests
Compared radiographic progression-free survival (rPFS) between treatment arms for detected HRR+ and BRCA+ patients
Out of 696 enrolled HRR+ patients, 549 were evaluated by the F1CDx assay, with a positive identification rate of 85.2% for HRR+
BRCA+ patients identified by F1CDx showed improved rPFS with a hazard ratio of 0.46 compared to overall BRCA+ patients
Clinical efficacy of NIRA+AAP was consistent in patients identified by F1CDx compared to the overall population in the study