After data from phase III ACIS study, Erleada + Zytiga combination will not be pursued for prostate cancer.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that regulatory submissions based on the Phase III ACIS study, which evaluated the combination of Erleada (apalutamide) and Zytiga (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued. As presented at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium in February 2021, the ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); however, combination treatment did not show significant benefit over the active control Zytiga plus prednisone in key secondary endpoints, including overall survival (OS).ACIS was a Phase III randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of Erleada and Zytiga plus prednisone compared to placebo and Zytiga plus prednisone in 982 patients with chemotherapy-naïve mCRPC who received ADT. The primary endpoint of the study was rPFS. Secondary endpoints of the study included OS, time to chronic opioid use, time to initiation of cytotoxic chemotherapy, and time to pain progression.