Sunesis Pharma's Phase 3 Valor Trial Fails To Meet Primary Endpoint

(RTTNews) - Sunesis Pharmaceuticals, Inc. (SNSS) Monday said its Phase 3 Valor trial evaluating vosaroxin and cytarabine in patients with first relapsed or refractory acute myeloid leukemia or AML, failed to meet its primary endpoint of showing a statistically significant improvement in overall survival, with a median overall survival of 7.5 months for vosaroxin and cytarabine compared to 6.1 months for placebo and cytarabine.

However, since transplant may confound the primary analysis, a predefined analysis of overall survival censoring for stem cell transplantation was planned and in this analysis, patients who received the vosaroxin combination had a median overall survival of 6.7 months versus 5.3 months for placebo and cytarabine. The trial also showed a clinically significant benefit in complete remission rate, the secondary endpoint.

Based on these results, the company said it plans to file a marketing authorization application with the European Medicines Agency and to meet the U.S. Food and Drug Administration to determine the appropriate regulatory path forward.