On April 28, 2014 Teva and OncoGenex reported results from the Phase III SYNERGY trial (NCT01188187), 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) (Press release Teva, APR 28, 2014, View Source [SID:1234500475]).
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).
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.