OncoGenex Pharmaceuticals has reported positive survival results from the final analysis of the Phase 2 Borealis-2 trial of apatorsen in combination with docetaxel treatment in 200 patients suffering from metastatic bladder cancer, whose disease had progressed following first-line platinum-based chemotherapy.
Patients who received apatorsen treatment saw a 20% reduction in risk of death, compared to patients receiving docetaxel alone.
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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 study was carried out by the Hoosier Cancer Research Network at 28 sites across the US.
Safety results in patients treated with apatorsen and docetaxel were similar to those observed in patients treated with docetaxel alone.
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Memorial Sloan Kettering Cancer Center MD and a principal investigator of the study Jonathan Rosenberg said: "People living with advanced bladder cancer who have failed initial therapies have few treatment options available to them.
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By GlobalData"While research across different treatment modalities is underway, there continues to be a high unmet therapeutic need.
"The totality of the data evaluating apatorsen across first-line and second-line chemotherapy treatment for bladder cancer suggests that it may provide clinical benefits in this highly aggressive disease."
Apatorsen is intended to restrict production of heat shock protein 27 (Hsp27) to disable cancer cells' defences 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.
OncoGenex president and CEO Scott Cormack said: "We are encouraged by this data that further supports Hsp27 as a therapeutic target and adds an additional level of evidence to previously completed trials of apatorsen in patients with bladder cancer.
"We look forward to completing the full data analysis from Borealis-2 and considering these data in our continuing work with MTS Health Partners in the exploration of strategic alternatives as announced in mid-August."
Borealis-2 is an investigator-sponsored, randomised Phase 2 trial analysing 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.
