Top-line survival results of OncoGenex Pharmaceuticals’ (NASDAQ:OGXI) Phase 3 SYNERGY trial indicate that 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 in men with metastatic castrate-resistant prostate cancer (CRPC), compared with docetaxel/prednisone alone.
Median survival in the treatment arm was 23.4 months vs. 22.2 months with docetaxel/prednisone alone. The adverse events observed were similar to custirsen’s known adverse event profile.
“The results of SYNERGY are unexpected, particularly given the wealth of scientific evidence supporting the targeting of custirsen to combat treatment resistance in first-line prostate cancer,” president and CEO Scott Cormack said in a statement.
Dr. Michael Hayden, president of global R&D and CSO at partner, Teva Pharmaceutical Industries, said the company is working with OncoGenex to more fully understand these data.
Mr. Cormack said OncoGenex continues to believe that addressing treatment resistance is critical in the fight against cancer. “We continue to actively pursue this approach through the two ongoing Phase 3 trials of custirsen and the seven Phase 2 trials of apatorsen in four tumor types.”
