ADXS-PSA is under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatments of metastatic castration-resistant prostate cancer (mCRPC).
ADXS-PSA is being evaluated in the Phase 1/2 KEYNOTE-046 study of ADXS-PSA as a monotherapy and in combination with Merck’s PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab) in 51 patients with mCRPC. The trial has completed dosing cohorts in Part A (dose escalation) of the trial with ADXS-PSA as a monotherapy, the first in-human study of this product candidate in prostate cancer. Enrollment for Part B will commence mid-year, evaluating ADXS-PSA in combination with KEYTRUDA®, followed by an expansion cohort phase. The primary objective is to evaluate the safety and tolerability of the two immunotherapies, with the secondary objective of evaluating anti-tumor activity and progression-free survival.