Sunesis Pharmaceuticals Announces Presentation of Results From Washington University Sponsored Phase 1/2 Trial of Vosaroxin in MDS and VALOR Analysis of Baseline Safety Predictors at ASH Annual Meeting
A Phase I Study of Vosaroxin Plus Azacitidine for Patients with Myelodysplastic Syndrome
In a Phase 1/2, open label, dose-escalation trial sponsored by the
Thirteen patients were enrolled in the dose-escalation phase and five of twenty planned patients have been enrolled in the expansion cohort to date. At the initial dose of 50 mg/m2/day vosaroxin, 2 of 6 patients experienced a DLT (grade 4 hyperbilirubinemia, and grade 4 neutropenia >42 days). The vosaroxin dose was de-escalated to 34 mg/m2/day, resulting in 1 of 6 patients with a DLT (grade 4 mucositis). Of the 18 patients enrolled to date, 16 completed ≥1 cycle and are evaluable for response. Best response for each patient was as follows: stable disease, n=3; stable disease with hematologic improvement (HI)-neutrophils, n=2; marrow complete remission (CR), n=4; marrow CR with HI-platelets; n=2; marrow CR with HI-neutrophils, n=1; marrow CR with HI-erythroid, n=1; and marrow CR with HI-platelets and neutrophils, n=1; and CR, n=1. One patient had progressive disease (PD). Of the 16 evaluable patients, 6 have proceeded to allogenic stem cell transplant and 3 are actively undergoing study treatment. The major non-hematologic toxicities of febrile neutropenia, infections, and mucositis were expected based on the disease population and prior experiences with vosaroxin.
"Hypomethlyating agents are the mainstay of treatment for myelodysplastic syndromes, yet these agents alone produce remissions in a minority of patients and are typically not curative," said
Baseline Predictors of Mortality in Patients with Relapsed or Refractory Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine in the Phase 3 VALOR Study
Treatment-related mortality (TRM) score is a prognostic scoring system to predict risk of 30-day mortality with intensive treatment protocols in patients with newly diagnosed AML (Walter, 2011, J Clin Oncol 29:4417-4424). The "simplified TRM" score includes age, performance status (PS), platelet count, serum albumin, type of AML (secondary vs primary), white blood cell count, blast percentage in the peripheral blood, and serum creatinine. In a retrospective analysis, TRM and other criteria were used to evaluate risk of early mortality in patients with relapsed or refractory acute myeloid leukemia treated with vosaroxin plus cytarabine or placebo plus cytarabine in Sunesis' randomized, double-blind, placebo-controlled Phase 3 VALOR trial.
A total of 705 patients from VALOR were included in the safety population (355 treated with vosaroxin/cytarabine and 350 treated with placebo/cytarabine). Rates of 30-day (7.9% vs 6.6%, respectively) and 60-day (19.7% vs 19.4%, respectively) mortality in VALOR were comparable between vosaroxin plus cytarabine and placebo plus cytarabine arms. Several individual baseline factors independently predicted risk of early mortality, including ECOG performance status, hemoglobin, bilirubin and albumin levels, intermediate or high bone marrow blasts, and prior myelodysplastic syndrome. The previously validated TRM score for predicting early mortality in newly diagnosed AML was also predictive of mortality in this relapsed/refractory population. Vosaroxin/cytarabine treatment and age were not significant predictors of early mortality.
"The rate of early mortality in patients treated for acute myeloid leukemia reflects a balance of efficacy and safety outcomes," said Dr.
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
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
This press release contains forward-looking statements, including statements related to Sunesis' expected progress in its kinase inhibitor pipeline. Words such as "may," "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' clinical studies for its product candidates 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, 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
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717