publication date: Mar. 30, 2017
Bladder and Prostate Cancers In phase II studies Apatorsen improved outcomes in bladder, prostate cancers
OncoGenex Pharmaceuticals Inc. said apatorsen results from two randomized phase II clinical trials were presented at the American Society of Clinical Oncology 2017 Genitourinary Cancers Symposium.
Clinical data from trials in bladder and prostate cancers demonstrated apatorsen was well-tolerated and improved patient outcomes when administered in combination with standard-of-care treatments.
Bladder Cancer Trial
The Borealis-2 trial evaluated apatorsen in combination with docetaxel treatment in 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. The primary endpoint analysis met the superiority test for overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test.
Patients who received apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving docetaxel alone (overall survival hazard ratio (HR)=0.80; 80% CI: 0.65-0.98; p=0.078).
Partial or complete responses occurred in 16.2% patients receiving apatorsen plus docetaxel compared to 10.9% patients receiving docetaxel alone with median response durations of 6.2 months versus 4.4 months, respectively.
Higher baseline serum Hsp27 levels were significantly prognostic for indicating an almost 2-fold higher risk of death (HR= 1.96; p=0.0001). In an exploratory analysis on a subset of patients (20% of total) who completed at least two treatment cycles and had either a decrease in serum Hsp27 … Continue reading CCL March 2017 – In phase II studies Apatorsen improved outcomes in bladder, prostate cancers
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