publication date: Nov. 29, 2016
Bladder Cancer Positive Survival Results from Apatorsen Phase II Trial in Metastatic Bladder Cancer
OncoGenex Pharmaceuticals Inc. announced today positive survival results from the final analysis of the phase II Borealis-2 trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy.
Patients who received apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving docetaxel alone (HR=.80; 95% CI: 0.65-0.98; p=0.078). The primary analysis was a superiority test of overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test. The trial was conducted by the Hoosier Cancer Research Network at 28 sites across the United States.
Safety results in patients treated with apatorsen and docetaxel were similar to those observed in patients treated with docetaxel alone.
Apatorsen is designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells’ defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes.
Borealis-2 is an investigator-sponsored, randomized phase II trial evaluating a survival benefit with apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in approximately 200 patients with metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy.
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