Sunesis Pharmaceuticals Announces Presentation of Responder Survival Analysis from Phase 3 VALOR Trial at the 2015 Chemotherapy Foundation Symposium
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
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
About QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that there will be approximately 20,830 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2015. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 75,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to Sunesis' estimated timelines for regulatory interactions and regulatory progress, including the anticipated submission of the MAA for vosaroxin with the EMA and plans to gain marketing approval of vosaroxin in the U.S., Sunesis' overall strategy, the design, conduct and results of clinical trials, including the expected progress in its kinase inhibitor pipeline, estimated new cases of AML, its prevalence across major global markets, prognosis for patients with AML, the need for and the role of vosaroxin as a potential new treatment option, and Sunesis' clinical development of vosaroxin, including the analysis of the results from the VALOR clinical trial. Words such as "anticipates," "estimates," "expect," "intends," "plan," "potential," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Sunesis may not be able to submit timely the MAA to the EMA, the risk that Sunesis' clinical studies for vosaroxin may not lead to regulatory approval in the U.S. or
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717