Sunesis Pharma Reports Presentation of Responder Survival Analysis from Phase 3 VALOR Trial at CFS

Sunesis Pharmaceuticals, Inc. SNSS today announced the presentation of a responder survival analysis from the Phase 3 VALOR trial at the 33rd Annual Chemotherapy Foundation Symposium (CFS) taking place at the Marriott Marquis in New York City. The results are being presented today, Wednesday, November 4th, at 6:00 p.m. as a poster during the general poster session in the Exhibit Hall. The poster presentation, titled "Impact of Complete Remission on Overall Survival in Patients with Refractory/Relapsed Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine: Responder Analysis for the Phase 3 VALOR Trial," will be available on the Sunesis website at www.sunesis.com, following the conclusion of the symposium. VALOR is a randomized, double-blind, placebo-controlled Phase 3 trial which enrolled 711 adult patients with first relapsed or refractory AML at 124 leading sites in 15 countries. Patients were stratified for age, geographic region and disease status and randomized one to one to receive either vosaroxin and cytarabine or placebo and cytarabine. The full results from VALOR were recently published in the September 2015 print issue of The Lancet Oncology. A post hoc landmark analysis was performed comparing overall survival (OS) by complete remission (CR) status. To mitigate the potential bias that early death would preclude CR, only patients alive at 60 days were included. Of the 711 patients in the VALOR intent-to-treat population, 570 patients were alive at the 60-day mark, including 285/356 (80%) in the vosaroxin/cytarabine arm and 285/355 (80%) in the placebo/cytarabine arm. At 60 days, the CR rate was 33.0% and 15.4% in the respective treatment arms. The addition of vosaroxin produced the greatest percentage increase in CR rate compared to the control arm in patients ≥ 60 y of age, patients with high blast count, and patients with refractory or early relapsed disease. These same patient groups also show the greatest OS benefit with the addition of vosaroxin. In both treatment arms and all study-strata, achievement of CR was associated with consistently longer median OS; patients with CR at 60 days had a median OS of 20.1 months (21.2 months with vosaroxin/cytarabine and 19.8 months with placebo/cytarabine), and patients without CR had a median OS of 7.1 months (7.3 and 7.1 months, respectively). Irrespective of treatment arm, OS was consistently prolonged in patients with CR. The stratified Chi-square statistical analysis of survival demonstrated a HR for CR of 0.42. "These data underscore the long-held clinical understanding that CR status is the strongest independent predictor of overall survival in patients with AML, with VALOR demonstrating a two-fold increase in CR with the addition of vosaroxin," said Harry Erba, MD, PhD, Professor of Medicine and Director of the Hematologic Malignancy Program at the University of Alabama at Birmingham. "Importantly, the CR benefit, and thus survival benefit, conveyed by the addition of vosaroxin is most evident in patients over 60 years of age and those with refractory or early relapsed disease. These data further demonstrate the potential of vosaroxin as a much needed new treatment option for patients with relapsed or refractory AML."