OncoGenex says Phase 3 ENSPIRIT trial did not meet primary endpoint
OncoGenex Pharmaceuticals announced results from the final analysis of the Phase 3 ENSPIRIT trial of custirsen in patients whose non-small cell lung cancer has progressed following initial treatments. The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with docetaxel compared to docetaxel alone. The median overall survival for the custirsen arm was 9.0 months versus 7.9 months for the control arm with a hazard ratio of 0.915 (one-sided p=0.178). Safety results were consistent with those observed in previous trials of custirsen in combination with chemotherapy. "Following the negative results of previous custirsen trials, an early final analysis of the ENSPIRIT trial was conducted in an effort to conserve capital and extend our cash runway," said Scott Cormack, President and CEO of OncoGenex. "We will continue to take appropriate steps to realize the most value for our shareholders once we receive the results of our apatorsen Phase 2 Borealis-2 bladder cancer trial which are expected by the end of October."