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Phase III results for vosaroxin and cytarabine in acute myeloid leukemia published in Lancet Oncology- Sunesis Pharma

Read time: 1 mins
Last updated: 5th Aug 2015
Published: 5th Aug 2015
Source: Pharmawand

Sunesis Pharmaceuticals announced that results from the Company's Phase III VALOR trial of vosaroxin and cytarabine in 711 patients with relapsed or refractory acute myeloid leukemia (AML) were published in the The Lancet Oncology. The VALOR results were first announced by the company on October 6, 2014. Although no significant difference was observed in the primary endpoint of overall survival (OS) between groups (unstratified analysis, median 7.5 months for vosaroxin and cytarabine [vos/cyt] vs 6.1 months for placebo and cytarabine [pla/cyt], HR=0.87, p=0.061), OS was significantly prolonged in a predefined analysis that stratified by factors used in randomization (stratified log-rank p=0.024).

The results describe how vosaroxin plus cytarabine, based on prespecified analyses, is the first regimen to show an overall survival benefit in relapsed/refractory AML, with the greatest benefit observed in patients older than 60 years, a population with limited treatment options.

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