OncoGenex Pharmaceuticals Inc (NASDAQ:OGXI) posted positive survival report from the final assessment of the Phase 2 Borealis-2™ study of apatorsen in combination with docetaxel cure. The trial registered 200 subjects with metastatic bladder cancer whose disease advanced due to first-line platinum-based chemotherapy.
Subjects who received apatorsen regimen witnessed a 20% decline in risk of death, against subjects getting docetaxel alone. The primary assessment was a superiority test of complete survival, achieved at a one-sided significance level of 0.10 applying a stratified log-rank test. This trial was performed by the Hoosier Cancer Research Network at over 25 sites across the U.S.
Safety report in subjects treated with docetaxel and apatorsen were similar to the data observed in subjects cured with docetaxel alone.
The experts speak
Jonathan Rosenberg, one of the principal investigators, reported that people who are suffering with advanced bladder cancer and have failed initial treatments have few treatment alternatives available to them. While there is intense research going on, there remains a high unmet therapeutic requirement. The totality of the evidence assessing apatorsen across first and second line chemotherapy regimen for bladder cancer indicates that it may offer clinical advantages in highly aggressive disease.
Apatorsen is intended to prevent production of Hsp27 to restrict cancer cells’ defenses and face treatment resistance. It is an intracellular protein meant to protect cancer cells by assisting them survive, leading to aggressive cancer phenotypes.
Scott Cormack, the CEO and President of OncoGenex, said that they are delighted by this data that support ‘Hsp27’ as a therapeutic target. It adds an additional level of proof to previously ended trials of apatorsen in subjects with bladder cancer. The management look forward to closing the full data assessment from Borealis-2 and considering this report in continuing assignment with MTS Health Partners in the consideration of strategic options as said in mid-August.
Borealis-2 is an investigator funded, randomized Phase 2 study assessing a survival advantage with apatorsen in conjunction with docetaxel regimen against docetaxel treatment alone in nearly 200 enrollments with metastatic bladder cancer. These patients have disease progression after first-line platinum-based chemotherapy.