Sunesis Announces Results From Pivotal Phase 3 VALOR Trial of Vosaroxin and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia
Trial Does Not Reach Primary Endpoint of Statistically Significant
Improvement in Overall Survival
Shows Significant Survival Benefit when Censored for Transplant
Safety Profile Consistent with that Observed in Previous Company Trials
Company Plans to Commence European Filing and Explore U.S. Regulatory Pathway
Sunesis to Host Conference Call and Webcast Today at
For age, the trial stratified patient populations into age 60 years and older and younger than 60 years at enrollment. Within a predefined analysis of patients younger than 60 years (n=260), where the rate of stem cell transplant was 45.8%, the vosaroxin combination demonstrated a median overall survival of 9.1 months, versus 7.9 months for placebo and cytarabine (HR=1.079, p=NS), and a CR rate of 26.9% versus 20.8% (p=0.24). In the analysis of patients aged 60 years and older (n=451), where the rate of stem cell transplant was 20.2%, the vosaroxin combination demonstrated a median overall survival of 7.1 months, versus 5.0 months for placebo and cytarabine (HR=0.755, p=0.006), and a CR rate of 31.9% versus 13.8% (p=0.0000048).
In the intent-to-treat population, 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. Thirty-day and 60-day all-cause mortality were comparable between the trial arms (7.9% versus 6.6% and 19.7% versus 19.4%, for the vosaroxin combination versus placebo and cytarabine, respectively).
Based on results of the trial, Sunesis plans to commence a marketing authorization application with the
The results reported above are based upon Sunesis' analysis of the data to date. Detailed results of the VALOR trial will be submitted for presentation at an upcoming medical conference.
"VALOR was a robust, well-conducted trial, among the largest in the relapsed or refractory AML setting. The study outcomes are very encouraging, and I look forward to a full presentation of the data in a peer-reviewed forum," said
"There remains an acute need for new treatment options in AML, particularly relapsed refractory patients, where no therapy has demonstrated a survival benefit in a pivotal Phase 3 trial in more than 40 years," said
"We are deeply grateful for the support and commitment of the AML investigators, the patients and families who took part in or contributed to VALOR," said
Conference Call and Webcast Information
Sunesis will host a conference call today, October 6, 2014, at 8:30 a.m. Eastern Time. The call can be accessed by dialing (866) 953-6856 (U.S. and Canada) or (617) 399-3480 (international), and entering passcode 37368874. To access the live audio, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on Sunesis' website for two weeks.
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.
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This press release contains forward-looking statements, including statements related to Sunesis' regulatory strategy (including plans to commence a marketing authorization filing with the EMA), Sunesis' preliminary analysis, assessment and conclusions of the results of the VALOR trial, and the efficacy and commercial potential of vosaroxin. It is possible that such results or conclusions may change based on further analysis of the VALOR data. Words such as "plans," "intends," "will," "believe," 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