On June 12, 2015 Sunesis reported additional results of the VALOR trial, a Phase 3 study of vosaroxin and cytarabine in adult patients with relapsed or refractory acute myeloid leukemia (AML) (Press release, Sunesis, JUN 12, 2015, View Source;p=RssLanding&cat=news&id=2058835 [SID:1234505411]). The results are being presented today, Friday, June 12th from 5:15 p.m. to 6:45 p.m. Central European Time at the acute myeloid leukemia (AML) poster session of the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place in Vienna, Austria.
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VALOR is a randomized, double-blind, placebo-controlled Phase 3 trial which enrolled 711 adult patients with first relapsed or refractory AML at 124 leading sites in 15 countries. Patients were stratified for age, geographic region and disease status and randomized one to one to receive either vosaroxin and cytarabine or placebo and cytarabine. Detailed results of the VALOR trial were presented in the "Late Breaking Abstracts" session of the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2014. Data from the post-hoc analysis of VALOR patients age 60 years and older who received allogeneic transplant after treatment with vosaroxin or placebo plus cytarabine were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May 2015 and now at the EHA (Free EHA Whitepaper) Congress.
Among the new data presented today are detailed results from the subgroups of patients age 60 years and older (451 out of 711 enrolled in VALOR) with late relapse (n=87) and refractory and early relapse disease (combined n=364).
Among patients with late relapse disease, overall survival (OS) and leukemia-free survival (LFS) were comparable between treatment arms. The complete remission (CR) rate was 57% and 28% (p=0.0064) and event-free survival (EFS) was 5.5 months versus 2.3 months (HR=0.65, p=0.0852) for vosaroxin/cytarabine and placebo/cytarabine, respectively. Thirty- and 60-day all-cause mortality among these patients was 11% and 18% versus 2% and 14% for vosaroxin/cytarabine and placebo/cytarabine, respectively.
Among patients with refractory and early relapse disease (combined n=364), a population known to have poorer outcomes, OS was 6.5 months versus 3.9 months for vosaroxin/cytarabine and placebo/cytarabine, respectively (HR=0.69, p=0.0008). CR rates in this population were 26% and 10% (p=0.0001) for vosaroxin/cytarabine and placebo/cytarabine, respectively. Among these patients, LFS was 9.7 months versus 5.5 months (HR=0.50, p=0.0424) and EFS was 1.7 months versus 1.3 months (HR=0.59, p<0.0001) for vosaroxin/cytarabine and placebo/cytarabine, respectively. Thirty- and 60-day all-cause mortality among these patients was comparable, at 10% and 21% versus 11% and 25% for vosaroxin/cytarabine and placebo/cytarabine, respectively.
In all patients age 60 years and older, Grade 3 or higher non-hematologic adverse events that were more common in the vosaroxin combination arm were gastrointestinal and myelosuppression-related toxicities, consistent with those observed in previous company trials. The rate of serious adverse events related to treatment was 74% and 60% for vosaroxin/cytarabine and placebo/cytarabine, respectively.
"AML is a disease that primarily affects older patients, and clinical outcomes among these patients is abysmal," said Farhad Ravandi, M.D., Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center, and a principal investigator of the VALOR study. "These patients have had few options outside of clinical trial enrollment. Results from the analyses presented today show compelling survival and durable responses with comparable early mortality for the vosaroxin and cytarabine treatment arm in the older refractory and early relapse patients. Given these results, I believe vosaroxin represents an important new treatment option."
"In over four decades of research, there has been far too little progress in the treatment of AML," said Patricia J. Goldsmith, CEO of CancerCare. "This need is particularly pronounced in those patients age 60 and older with the fewest options. Progress for these patients cannot wait."
The two poster presentations (Abstracts #4192 and #4693, Hall C), titled "Improved survival in patients ≥60 with first relapsed/refractory acute myeloid leukemia treated with vosaroxin plus cytarabine vs placebo plus cytarabine: results from the Phase 3 VALOR study" and "Allogeneic transplant in patients ≥60 years of age with first relapsed or refractory acute myeloid leukemia after treatment with vosaroxin or placebo plus cytarabine: results from VALOR," will be available on the Sunesis website at www.sunesis.com. In addition, an E-poster, titled "Impact of cytogenetics on clinical outcomes in patients with first relapsed or refractory acute myeloid leukemia treated with vosaroxin plus cytarabine: results from VALOR," is on display at EHA (Free EHA Whitepaper) through tomorrow, Saturday, June 13th at 6:45 p.m. Central European Time.