Phase III trial of OGX 011 (custirsen) in metastatic castrate-resistant prostate cancer fails to meet endpoint- OncoGenex Pharmaceuticals

OncoGenex Pharmaceuticals has announced results from the final analysis of AFFINITY, the Phase III trial of OGX 011 (custirsen) in men with metastatic castrate-resistant prostate cancer (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 FDA to evaluate options related to an early analysis of the Phase III ENSPIRIT trial investigating custirsen in combination with docetaxel as second-line chemotherapy in patients with non-small cell lung cancer (NSCLC).