UPDATE: Sunesis Reports Schedule C Had Most Favorably Safety/Efficacy Balance

Sunesis Pharmaceuticals, Inc.

today announced the publication of results from the Company's REVEAL-1 (Response Evaluation of Vosaroxin in Elderly AmL) trial, a Phase 2 trial of single agent vosaroxin in previously untreated, poor-risk elderly acute myeloid leukemia (AML) patients who are unlikely to benefit from standard induction chemotherapy, in the November 17, 2014 Online Version of Record of the British Journal of Haematology. The article, titled "REVEAL-1, a phase 2 dose regimen optimization study of vosaroxin in older poor-risk patients with previously untreated acute myeloid leukemia," is available online at http://onlinelibrary.wiley.com/doi/10.1111/bjh.13214/abstract. "There remains an acute unmet medical need for new treatment options in AML, including patients 60 years of age and older who are unlikely to benefit from standard induction chemotherapy," stated Farhad Ravandi, M.D., Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center, and an author of the publication. "Vosaroxin is active and well tolerated in this population, both as a single agent, as seen in the REVEAL-1 study, and in combination with decitabine, as seen in an ongoing MD Anderson Cancer Center-sponsored study. Vosaroxin's activity in AML is further highlighted in the recent outcome of the randomized, double-blind, placebo-controlled Phase 3 VALOR trial, which looks at combination therapy with cytarabine in the relapsed and refractory settings. In their totality, these data suggest an important role for vosaroxin in the treatment of AML." The REVEAL-1 study evaluated single-agent vosaroxin in patients ≥60 years of age (n=113) with previously untreated unfavorable prognosis AML. Dose regimen optimization was explored in sequential cohorts (A: 72 mg/m^2 on days 1, 8, 15; B: 72 mg/m^2 on days 1, 8; C: 72 mg/m^2 or 90 mg/m^2 on days 1, 4). The primary efficacy endpoint was combined complete remission rate (complete remission [CR] plus CR with incomplete platelet recovery [CRp]). The median age in the study was 75 years and most patients (82%) had 2 or more risk factors (age ≥ 70, antecedent hematologic disease [AHD], ECOG PS=2, or intermediate/unfavorable cytogenetics). Common (>20%) grade ≥3 adverse events were thrombocytopenia, febrile neutropenia, anemia, neutropenia, sepsis, pneumonia, stomatitis, and hypokalemia. Overall CR and CR/CRp rates were 29% and 32%; median overall survival (OS) was 7.0 months; 1-year OS was 34%. Schedule C (72 mg/m^2) had the most favorable balance of safety and efficacy, with faster hematologic recovery (median 27 days) and lowest incidence of aggregate sepsis (24%) and 30-day (7%) and 60-day (17%) all-cause mortality. At this dose and schedule, CR and CR/CRp rates were 31% and 35%, median OS was 7.7 months, and 1-year OS was 38%. "Publication of these data in the British Journal of Haematology further support our goal of establishing vosaroxin as a new standard of care in AML," said Adam Craig, Chief Medical Officer of Sunesis. "Given ongoing demographic shifts in the U.S. and other major territories, the challenge of treating AML in older adults will continue to grow, underscoring a need for new treatment options. We look forward to building on these data through further investigator-sponsored studies and, with the outcome of VALOR in relapsed or refractory AML, progressing towards initial regulatory approval." As recently announced, based on results of the VALOR trial, Sunesis has commenced a marketing authorization application (MAA) with the European Medicines Agency (EMA) and plans to meet with the U.S. Food and Drug Administration to determine the appropriate regulatory path forward for vosaroxin in the treatment of relapsed or refractory AML.