Veracyte, Inc. announced new data from the prospective, randomized integral biomarker BALANCE trial (NCT03371719), presented at ASTRO 2025, finding that the PAM50 molecular signature predicts which patients with recurrent prostate cancer benefit from hormone therapy with apalutamide in addition to salvage radiation therapy. This marks the first time a predictive biomarker has been validated in a prospective, biomarker-driven, randomized trial in non-metastatic prostate cancer.
Among the 127 men with luminal B molecular subtype tumors, 72% taking apalutamide did not experience biochemical failure, compared to a 54% rate in the placebo group. In contrast, no difference was observed in the non-luminal B subset, highlighting the biomarker's predictive power.
This advancement is considered a 'game changer' for personalizing treatment for men with recurrent prostate cancer, moving beyond merely prognostic tools. The PAM50 biomarker, currently available for Research Use Only on the Decipher GRID research tool, provides an unprecedented ability to select patients more precisely for hormone therapy or to forego the treatment and its potential side effects.
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