Sunesis Pharmaceuticals has completed enrolment in the pivotal Phase III VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory acute myeloid leukemia (AML).
A total of 712 patients were enrolled in the randomised, double-blind, placebo-controlled trial.
The company expects to unblind the study in the first half of 2014 on completing 562 events and locking the final study database.
Under the Phase III study, patients will be randomised in a ratio of 1:1 to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine.
Evaluating overall survival is the primary endpoint of VALOR.
VALOR is being conducted at more than 100 leading sites in the US, Canada, Europe, Australia, New Zealand and South Korea.
Sunesis Pharmaceuticals executive vice president of development and chief medical officer Adam Craig said better investigator support for VALOR from across the company’s more than 100 sites globally has allowed it to complete enroling VALOR on schedule.
"With over 700 patients enrolled, VALOR is well powered to demonstrate a clinically meaningful improvement in overall survival, the study’s primary endpoint," Craig said.
"We look forward to top-line results in the first half of 2014 and, with a positive outcome, to seeing vosaroxin change the global standard of care in this important area of unmet medical need."
VALOR was initiated following promising results from a Phase II study of vosaroxin in combination with cytarabine in patients with relapsed or refractory AML.
Results from the Phase II study showed a balance of improved remission rates translating into long leukemia-free survival, including the opportunity to bridge to potentially curative bone marrow transplants – and low induction mortality.
Approximately 700 AML patients have been treated with vosaroxin in the previous and ongoing studies.
Vosaroxin, a first-in-class anti-cancer quinolone derivative (AQD), received orphan drug designation from both the US Food and Drug Administration (FDA) and European Commission for the treatment of AML.
It has also obtained the FDA fast track designation for the potential treatment of relapsed or refractory AML in combination with cytarabine.