publication date: Sep. 22, 2016
Prostate Cancer Custirsen Trial Fails to Show Improvement in Survival
The phase III AFFINITY study failed to show a statistically significant improvement in overall survival for patients treated with custirsen in combination with cabazitaxel/prednisone compared to cabazitaxel/prednisone alone.
The trial studied custirsen in men with metastatic castrate resistant prostate cancer whose disease had progressed after treatment with docetaxel. The results were consistent with those observed in previous trials of custirsen in metastatic CPRC.
Custirsen is sponsored by OncoGenex Pharmaceuticals Inc.
The company said that as a result of these data and previous custirsen findings it will initiate discussions with 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).
“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,” Scott Cormack, president and CEO of OncoGenex, said in a statement.
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