Sunesis Pharmaceuticals Announces Presentation of Results From Phase 3 VALOR Trial at ASH Annual Meeting
"Despite 40 years of intense clinical research, there remain no new approved treatments or standard of care for patients with relapsed or refractory AML," said
"When we compare AML to other blood cancers, the complete absence of new therapies introduced in the last two decades, particularly in
The randomized, double-blind, placebo-controlled Phase 3 VALOR trial 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. Patients treated with vosaroxin achieved increased overall survival compared to those treated with placebo (7.5 months vs 6.1 months, HR=0.865), the primary endpoint, but this difference did not achieve statistical significance (p=0.06). The complete remission (CR) rate, the sole secondary efficacy endpoint in the trial, did demonstrate a significant difference for the vosaroxin combination arm (30.1% vs 16.3%, p < 0.0001).
In a pre-planned analysis accounting for the stratification factors at randomization, a significant improvement in overall survival was demonstrated (HR=0.830, p=0.02). The pre-planned analysis of all treatment strata included the following poor-prognosis patient categories: over 60 years old (7.1 months vs 5.0 months, HR=0.75, p=0.006, n=451), refractory disease (6.7 months vs 5.0 months, HR=0.87, p=0.26, n=301), and early relapsed disease (6.7 months vs 5.2 months, HR=0.77, p=0.05, n=256). Outcomes in patients under 60 years old or with late relapsed disease were comparable between treatment arms, with no improvement in overall survival. Across all strata, the CR and Composite CR (CR+CRp+Cri) rates were higher in the vosaroxin combination arm.
Given the complexity of interpreting the impact of transplantation therapy, a sensitivity analysis of overall survival censoring for hematopoietic stem cell transplantation was planned. In this analysis, patients receiving the vosaroxin combination had a median overall survival of 6.7 months versus 5.3 months for patients receiving placebo and cytarabine (HR=0.809, p=0.02).
Grade 3 or higher non-hematologic adverse events that were more common in the vosaroxin combination arm were gastrointestinal and infection-related toxicities, consistent with those observed in previous company trials. The rate of serious adverse events was 55.5% in the vosaroxin combination arm compared to 35.7% in the placebo and cytarabine arm. All-cause mortality were comparable between the treatment arms (7.9% vs 6.6% for 30-day and 19.7% vs 19.4% for 60-day).
"As the largest randomized company-sponsored trial ever conducted in relapsed or refractory AML, VALOR provides a robust dataset that we are pleased to see presented at ASH's Late Breaking session," said
As previously announced, Sunesis has submitted a letter of intent describing the company's intention to file a Marketing Authorization Application (MAA) with the
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About QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that QINPREZO both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the
The trademark name QINPREZO is conditionally accepted by the
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of
This press release contains forward-looking statements, including statements related to Sunesis' preliminary analysis, assessment and conclusions of the results of the VALOR trial, the efficacy and commercial potential of vosaroxin and Sunesis' regulatory strategy (including plans to commence a marketing authorization filing with the EMA). It is possible that such results or conclusions may change based on further analysis of the VALOR data. Words such as "believe," "expect," "explore," "look forward," "potential," "seek," "will," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Sunesis' preliminary analysis, assessment and conclusions of the results of the VALOR trial set forth in this release may change based on further analysis of such data, the risk that Sunesis' plans to commence a marketing authorization filing with the EMA may change or such filing may be rejected by the EMA and the risk that Sunesis' clinical studies for vosaroxin may not lead to regulatory approval. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-K for the year ended
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals, Inc.650-266-3717