Sunesis Announces Presentation of Positive Updated Results from Ongoing MD Anderson-Sponsored Trial of Vosaroxin in AML and High-Risk MDS at ASH Annual Meeting
The Phase 1b/2 trial is expected to enroll up to a total of approximately 70 patients. Patients in the ongoing trial are being followed for response, leukemia-free survival, overall survival and safety. To date, 41 patients (38 AML, 3 high-risk MDS) with a median age of 70 years (range, 41-78) have been enrolled; 97% were older than 60 years and 51% were older than 70 years. Of the 37 patients evaluable for response, 22 patients (59%) achieved complete response (CR), 5 patients (14%) achieved CR with incomplete platelet recovery (CRp), and 1 patient (3%) achieved CR with incomplete peripheral blood count recovery (CRi), for an overall response rate of 76%. Preliminary median overall survival was 8.3 months. Median duration of response for patients achieving CR/CRp/CRi has not been reached. Patients have received a median of 2 (1 - 7) treatment cycles with median number of cycles to response being 1 (1 - 4). Six patients (16%) have proceeded to allogeneic stem cell transplant (ASCT) and 6 patients have relapsed.
Four-week and 8-week mortality were 0% and 14%, respectively. Infection related toxicities were the most common Grade ≥3 adverse events. Grade ≥3 toxicity was mucositis was observed in 11 patients (30%).
Patients were also assessed for response by baseline characteristics, including mutation status. Responses among these patients were as follows:
|-5/-7/other adverse||9/13 (69%)|
|Mutation Status||IDH2||7/7 (100%)|
*1 patient below the age of 60 years was unsuitable for standard chemotherapy and was enrolled on study.
"As with virtually all patient populations with this disease, older patients who are not candidates for standard frontline chemotherapy have few treatment options and poor prognoses," said Naval Daver, M.D., Assistant Professor,
"As we see in our Phase 3 VALOR study, the high response rates observed with vosaroxin used in various treatment combinations suggests clinical benefit in the context of a manageable safety profile," said
For the trial, patients are treated with vosaroxin (70 or 90 mg/m2) intravenously on days one and four in combination with decitabine (20 mg/m2) on days one to five. Vosaroxin dose is 70 mg/m2 in consolidation cycles, which are 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 are allowed based on toxicity. Patients are eligible if they had AML or high-risk MDS (defined as having ≥ 10% blasts in the bone marrow), are 60 years of age or older, and have adequate performance status (ECOG ≤ 2) and organ function. Patients younger than 60 who are unsuited for standard chemotherapy are also eligible. The primary endpoint of the study is to determine the overall combined complete response rate. Secondary endpoints include CR duration, disease-free survival, overall survival, safety and early mortality.
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' overall strategy, the design, conduct, progress, timing and results of Sunesis' clinical trials, the preliminary analysis, assessment and conclusions of the results of the VALOR trial and Sunesis' other clinical trials, and the efficacy and commercial potential of vosaroxin. Words such as "believe," "expect," "explore," "look forward," "potential," "suggest," "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, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of QINPREZO, 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 QINPREZO, the risk that Sunesis' development activities for QINPREZO could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for QINPREZO 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, risks related to the conduct of Sunesis' clinical trials, 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