Sunesis Announces Presentation of Positive Results From Ongoing MD Anderson-Sponsored Trial of Vosaroxin in AML and High-Risk MDS
Data Presented at AACR 2014 Annual Meeting
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The Phase 1b/2 trial is expected to enroll up to a combined total of approximately 70 patients. As previously announced, the Phase 2 cohort of the Phase 1b/2 was initiated in
"The treatment of older patients with AML or high-risk MDS presents particular challenges, including many patients not tolerating or responding to existing therapies," said
"Vosaroxin's activity against genetically heterogeneous diseases like AML and high-risk MDS is driven by its unique characteristics as a first-in-class, anti-cancer quinolone derivative – properties that appear to combine well with the anti-leukemic activity of decitabine, a hypomethylating agent, to provide a much higher rate of remission than would be expected from decitabine alone," said Adam R. Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis. "These encouraging results support our goal of elucidating vosaroxin's full clinical benefit in different patient segments as well as in new treatment combinations. We look forward to additional progress in this study and to working closely with MD Anderson and our growing list of experienced investigators to explore vosaroxin's value within AML and MDS."
Results in Detail
For the trial, patients were treated with vosaroxin (90 mg/m2) intravenously on days one and four in combination with decitabine (20 mg/m2) on days one to five. Vosaroxin dose was reduced to 70 mg/m2 in consolidation cycles, which were repeated in approximately four to five week intervals for a total of up to seven cycles. Dose adjustments and dose delays of one or both agents were allowed based on toxicity. Patients were eligible if they had AML or high-risk MDS (defined as having ≥ 10% blasts in the bone marrow), were 60 years of age or older, and had adequate performance status (ECOG ≤ 2) and organ function. Patients younger than 60 who were unsuited for standard chemotherapy were also eligible. The primary endpoint of the study is to determine the CR rate. Secondary endpoints include CR duration, disease-free survival, overall survival, safety and early mortality.
To date, 29 patients (25 AML, 4 high-risk MDS) with a median age of 73 years (range, 41-78) have been enrolled; 97% were older than 60 years and 59% were older than 70 years. Of these, 24 patients were evaluable for response; 9 (38%) achieved CR, 5 (21%) achieved CRp, and 2 (8%) achieved CRi, for an overall response rate of 67%. One patient without a response after cycle one is currently undergoing re-induction. Five patients are too early for response assessment. Patients have received a median of 2 (1-6) treatment cycles with median number of cycles to response being 1 (1-4).
The regimen was found to be well tolerated. The main grade ≥ 3 toxicity was mucositis in 6 (6/29, 21%) patients. No patients died during the initial 30-day induction period.
Conference Call Information
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Vosaroxin is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
MDS is a hematopoietic stem cell neoplasm that features dysplasia of the myeloid lineage. Hematopoiesis in these patients is disordered and ineffective. As the number and quality of blood-forming cells decline irreversibly, blood production is further impaired and patients often develop severe anemia requiring frequent blood transfusions. In most cases, the disease worsens and the patient develops neutropenia and thrombocytopenia caused by progressive bone marrow failure. In about one third of patients with MDS, the disease progresses into AML, usually within months to a few years.
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's overall strategy, the design, conduct, progress, timing and results of Sunesis' clinical trials and the commercial potential for vosaroxin. Words such as "approximately," "believe," "effective," "encouraging," "expected," "explore," "look forward," "meaningful," "potential," "promise," "responding," "well tolerated" 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, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, risks related to whether outstanding warrants will be exercised in the future, risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vosaroxin, the risk that raising funds through lending arrangements may restrict our operations or produce other adverse results, the risk that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the
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