SAN FRANCISCO (TheStreet) -- Sunesis Pharmaceuticals' (SNSS) experimental leukemia drug vosaroxin underwent a miraculous transformation during a Sunday morning press briefing at the American Society of Hematology here.
Vosaroxin should be considered a new standard of care for elderly patients with relapsed acute myeloid leukemia, based on a statistically significant improvement in survival seen in a phase III study, said Dr. Farhad Ravandi of the University of Texas MD Anderson Cancer Center.
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Listening to Ravandi's encomium to vosaroxin was surreal because the phase III study failed. Elderly AML patients treated with vosaroxin and cytarabine did not live any longer than patients treated with cytarabine alone. The 13% reduction in the risk of death favoring vosaroxin was NOT statistically significant. There's a sliver of daylight between the overall survival curves, but even this tiny sign of hope is a false signal. Remember, Sunesis added 225 patients to the study at an interim analysis to improve the odds of success.
Never once during Ravandi's presentation of the vosaroxin data during the ASH media briefing did he acknowledge the study's failure. Instead, he relied on a long list of alternative analyses -- conjured up by Sunesis -- to make his point.
Hmmm. Three of the five pre-planned analyses still fail to reach statistical significance.
Then there's this slide, which tracks overall survival after removing from the study patients who underwent a stem cell transplant.
Left off this slide is the hazard ratio of 0.80, which translates into a 20% reduction in the risk of death favoring vosaroxin. Sunesis claims this survival benefit was statistically significant, but is it clinically meaningful to relapsed AML patients? Should a drug which failed a large, phase III study in relapsed AML still be approved just because there are few, if any, effective treatments available?
The vosaroxin study results were "underwhelming," said Dr. David Steensma of the Brigham and Women's Hospital in Boston. Steensma was the moderator of the media briefing where Ravandi presented the vosaroxin study results.
"It's difficult to say where this drug [vosaroxin] would fit into the treatment of relapsed AML," added Steensma. "This is not a great leap forward... We need to work harder."