Vosaroxin: Additional Phase III data

A post hoc analysis of 87 patients ages >=60 with late relapse in the double-blind, international Phase III VALOR trial in 711 patients with first relapsed or refractory AML showed that IV vosaroxin plus cytarabine led to a complete remission rate of 57% vs. 28% for placebo plus cytarabine (p=0.0064). Vosaroxin plus cytarabine led to an EFS of 5.5 months vs. 2.3 months for placebo plus cytarabine (HR=0.65, p=0.0852). Additionally, vosaroxin plus cytarabine led to 30- and 60-day all-cause mortality rates of 11% and 18%, respectively, vs. 2% and 14% for placebo plus cytarabine.

In 364 patients ages >=60 with refractory and early relapse disease, vosaroxin plus cytarabine led to a complete remission rate of 26% vs. 10% for placebo plus cytarabine (p=0.0001). Vosaroxin plus cytarabine led to an OS of 6.5 months vs. 3.9 months for placebo plus cytarabine (HR=0.69, p=0.0008). EFS was 1.7 months for vosaroxin plus cytarabine vs. 1.3 months for placebo plus cytarabine (HR=0.59, p<0.0001) and LFS was 9.7 months for vosaroxin plus cytarabine vs. 5.5 months for placebo plus cytarabine (HR=0.5, p=0.0424). Additionally, vosaroxin plus cytarabine led to 30- and 60-day all-cause mortality rates of 10% and 21%, respectively, vs. 11% and 25% for placebo plus cytarabine. Data were presented at the American Society of Clinical Oncology meeting in Chicago and at the European Hematology Association meeting in Vienna. ...