OncoGenex: AFFINITY Custirsen Trial For Metastatic CRPC Fails To Meet Main Goal

(RTTNews) - OncoGenex Pharmaceuticals, Inc. (OGXI) announced Tuesday that Phase 3 AFFINITY Trial of Custirsen in Men with Metastatic Castrate-Resistant Prostate Cancer or CRPC did not meet the primary endpoint.

The company was announcing the final analysis of the Phase 3 trial of custirsen in men with CRPC whose disease has progressed after treatment with docetaxel. The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with cabazitaxel/prednisone compared to cabazitaxel/prednisone alone.

The adverse events were consistent with those observed in previous trials of custirsen in metastatic CRPC. The final data will be submitted as a late-breaking abstract to the European Society for Medical Oncology (ESMO) Annual Congress 2016.

As a result of these data and previous custirsen findings, OncoGenex plans to initiate discussions with the Food and Drug Administration to evaluate options related to an early analysis of the Phase 3 ENSPIRIT trial investigating custirsen in combination with docetaxel as second-line chemotherapy in patients with non-small cell lung cancer or NSCLC.

Scott Cormack, President and CEO of OncoGenex, said, "We are obviously disappointed that custirsen was unable to demonstrate a survival benefit in prostate cancer."