Teva and OncoGenex announce top-line survival results of Phase III SYNERGY trial evaluating custirsen in combination with first-line docetaxel and prednisone for metastatic castrate-resistant prostate cancer
Posted: 28 April 2014 | | No comments yet
Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced results from the Phase III SYNERGY trial…
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) today announced results from the Phase III SYNERGY trial, a randomized, open-label, two-arm study comparing the combination of custirsen and standard first-line docetaxel/prednisone therapy to docetaxel/prednisone alone in men with metastatic castrate-resistant prostate cancer (CRPC).
Top-line survival results indicate the addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet the primary endpoint of a statistically significant improvement in overall survival (OS) in men with metastatic CRPC, compared to docetaxel/prednisone alone (median survival 23.4 months vs 22.2 months, respectively; hazard ratio 0.93 and one-sided p-value 0.207).
“We are disappointed with these results. Addressing treatment resistance is critical in the fight against cancer. We are working with OncoGenex to more fully understand these data,” said Michael Hayden, MD, president of global R&D and chief scientific officer at Teva Pharmaceutical Industries Ltd.
The adverse events (AEs) observed for custirsen were similar to its known AE profile.
Full efficacy and safety data from SYNERGY will be submitted for presentation at an upcoming scientific conference.