Sunesis Pharmaceuticals Announces Presentation of VALOR Trial Subgroup Analysis at ASCO 2015 Annual Meeting
The poster presentation (Poster #44, S Hall A), titled "Allogeneic hematopoietic cell transplant (HCT) in patients (pts) ≥ 60 years of age with first relapsed or refractory acute myeloid leukemia (R/R AML) after treatment with vosaroxin plus cytarabine (pla/cyt): results from VALOR", will be available on the Sunesis website at www.sunesis.com, following the
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. Detailed results of the VALOR trial were presented in the "Late Breaking Abstracts" session of the
Of the 711 patients enrolled in VALOR, 451 patients were age 60 years and older. Of these, 226 patients were randomized to the vosaroxin/cytarabine arm and 225 patients to the placebo/cytarabine arm. For the subgroup analysis, complete remission (CR) rates prior to HCT, post-treatment HCT rates, HCT outcomes, and overall survival by treatment arm were assessed. Of the 451 patients, HCTs were performed in 91 patients, including 47 patients in the vosaroxin/cytarabine arm and 44 patients in the placebo/cytarabine arm. Of these patients, 27 (57%) achieved a CR prior to transplant in the vosaroxin/cyrarabine arm versus 16 (36%) in the placebo/cytarabine only arm. An additional 7 and 6 patients on the respective treatment arms received subsequent therapy, and went on to achieve a CR, resulting in a total of 34 patients (72%) in the vosaroxin/cytarabine arm and 22 patients (50%) in the placebo/cytarabine arm achieving CR prior to transplant.
Median overall survival for patients who underwent HCT was 20.2 months for the vosaroxin/cytarabine arm versus 12.2 months on placebo/cytarabine arm (HR 0.699; p=0.18). There were no clinically meaningful differences between treatment arms with respect to transplantation type, complications associated with HCT, 100-day mortality, or achievement of engraftment.
"Due to wider donor availability and improvements in supportive care, increasing numbers of older AML patients undergo allogeneic hematopoietic cell transplants," said Dr.
"The VALOR data reveal a compelling overall clinical profile of vosaroxin/cytarabine in relapsed and refractory AML, particularly among the most difficult to treat patient populations, including patients age 60 years and older," 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
The trademark name QINPREZO is conditionally accepted by the
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
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.
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This press release contains forward-looking statements, including statements related to Sunesis' overall strategy, the design, conduct and results of Sunesis' clinical trials, including the analysis, assessment and conclusions of the results of the VALOR trial, the commercial potential of vosaroxin, estimated new cases of AML, its prevalence across major global markets, prognosis for patients with AML, and the need for new treatment options, Sunesis' clinical development of vosaroxin, including the analysis of the results from VALOR clinical trial. Words such as "estimate," "potential," "promising," "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' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, risks related to the conduct of Sunesis' clinical trials, the risk that Sunesis' clinical studies for vosaroxin may not lead to regulatory approval, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, and risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vosaroxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Sunesis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717