VALOR is a pivotal Phase 3, randomized, controlled, double-blind, multinational clinical
trial evaluating the efficacy and safety of vosaroxin (VŌZ-ah-rox-in)—a first-in-class anticancer quinolone derivative (AQD)—plus cytarabine versus placebo plus
cytarabine for patients with first relapsed or refractory acute myeloid leukemia (AML).
- 90% power to detect a 40% improvement in overall survival.
- Innovative, adaptive trial design allows for a one-time sample size adjustment by
the Data Safety Monitoring Board at the interim analysis to ensure adequate power
across a broader range of clinically meaningful and statistically significant survival
- Dose and schedule: Vosaroxin 90 mg/m2 10-minute infusion or placebo on days 1
and 4; cytarabine (IDAC) 1 g/m2 given as a 2-hour IV infusion on days 1 through 5.
- In a Phase 2 trial in patients who mirror the entry criteria for VALOR, the vosaroxin
plus cytarabine regimen resulted in a median overall survival of 7.1 months, and a
combined complete remission rate (CR+CRp+CRi) of 29% (CR rate of 25%). Early
mortality rates were low, with 30-day and 60-day all-cause mortality rates of 3%
and 9%, respectively. Infection-related toxicities were the most common Grade 3
or higher nonhematologic adverse events.1