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VALOR: Vosaroxin improved survival in AML
SAN FRANCISCO — Combination therapy with vosaroxin and cytarabine was associated with longer OS in a cohort of more than 700 patients with acute myeloid leukemia, according to results of a phase 3 study.
Vosaroxin (Quinprezo, Sunesis) is a first-in-class anticancer quinolone derivative active in AML.
“Vosaroxin is minimally metabolized, evades P glycoprotein receptor–mediated efflux and has activity independent of p53 status,” Farhad Ravandi, MD, professor of medicine in the department of leukemia at The University of Texas MD Anderson Cancer Center, said during a presentation.
Ravandi and colleagues conducted a randomized phase 3, adaptive design, double blind, placebo-controlled trial to compare vosaroxin plus cytarabine with placebo plus cytarabine in patients with relapsed or refractory AML.
“These patients were homogenized as much as possible,” Ravandi said. “Importantly, all of these patients had to have received at least one cycle of cytarabine and anthracycline.”
The analysis included 711 patients in an intention-to-treat population.
“This is probably the largest study in relapsed AML,” Ravandi said.
OS served as the primary endpoint.The median OS for the study drug was 6.7 (5.4-8.1) months, compared with 5.3 (4.4-6.3) months for placebo (P=.06).
Patients in the vosaroxin group demonstrated a 30% complete response rate, compared with 16% among controls.
“The advantage was clearly superior for the vosaroxin arm of the study,” Ravandi said.
When OS was censored for allogeneic stem cell transplantation, results were 6.7 (5.4-8.1) months for the vosaroxin arm and 5.3 (4.4-6.3) months for controls (P=.02).
“We can see a statistically significant advantage for vosaroxin/cytarabine,” Ravandi said.
Stratified analysis results demonstrated an advantage of the study drug for patients aged older than 60 years, according to Ravandi.
“For patients younger than 60, there was no advantage for the vosaroxin arm,” he said.
Researchers observed no significant difference in mortality at 30 or 60 days between study arms. Thirty-day mortality rates were 7.9% (5.3-11.2) for the vosaroxin arm and 6.6% (4.2-9.7) for controls. At 60 days, the rates were 19.7% (15.7-24.2) in the vosaroxin arm and 19.4% (15.4-24.0) among controls.
“In my opinion, these data support the use of this therapy in older patients with AML,” Ravandi concluded.
For more information:
Ravandi F. Abstract LBA-6. Presented at: ASH Annual Meeting and Exhibition; Dec. 5-9, 2014; San Francisco.
Disclosure: Ravandi reports associations with Sunesis.
Perspective
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This study did show benefit of survival in patients who received vosaroxin. By statistical assessment, the analysis was of borderline significance, but there did seem to be an advantage — particularly in older patients. Overall, the drug seemed to be well tolerated in this setting of patients who are relapsed or have refractory disease and, therefore, have been previously treated and are prone to complications related to their leukemia and their treatment. This drug adds a potential new agent to our treatments for patients who are in a difficult situation with relapse or refractory AML. Whether this will ultimately get approved by the FDA, we’ll need to wait and see. The results are favorable enough that it should be given serious consideration.