OncoGenex Pharma (OGXI) Announces Custirsen Phase 3 Missed Primary Endpoint in Metastatic CRPC

August 16, 2016 7:01 AM EDT

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OncoGenex Pharmaceuticals, Inc. (Nasdaq: OGXI) announced results from the final analysis of AFFINITY, the Phase 3 trial of 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.

"We are obviously disappointed that custirsen was unable to demonstrate a survival benefit in prostate cancer. We would like to thank the patients who participated in the AFFINITY trial and their caregivers, as well as the investigators and their teams for their commitment to improving cancer care for patients who are in desperate need of new treatment options," said Scott Cormack, President and CEO of OncoGenex.

As a result of these data and previous custirsen findings, OncoGenex plans to initiate discussions with the U.S. Food and Drug Administration (FDA) 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 (NSCLC).

"Given that the ENSPIRIT trial has nearly completed enrollment and we believe there are likely a sufficient number of events to determine the effect of custirsen in NSCLC, we are eager to expedite the final data analysis, which would allow us to conserve resources and fully understand the value of the asset as we evaluate our alternatives to maximize shareholder value," said Cormack.

OncoGenex has engaged MTS Health Partners, LP as its advisor to assist with the exploration of strategic alternatives.

Conference Call Details OncoGenex will host a conference call at 7:30 a.m. Eastern Time today, Tuesday, August 16, 2016, to discuss today's news. A live event will be available on the Investor Relations section of the OncoGenex website at www.OncoGenex.com. Alternatively, visitors may access the live conference call by dialing (877) 606-1416 (U.S. & Canada) or (707) 287-9313 (International). A webcast replay will be available approximately two hours after the call and will be archived on www.OncoGenex.com for 90 days.

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