Sunesis Announces Presentation of Positive Updated Results From Ongoing MD Anderson-Sponsored Trial of Vosaroxin in AML and High-Risk MDS at ASCO 2014 Annual Meeting
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 was initiated in
To date, 34 patients (31 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 50% were older than 70 years. Of these, 30 patients were evaluable for response; 13 patients (43%) achieved complete response (CR), 6 patients (20%) achieved CR with incomplete platelet recovery (CRp), and 3 patients (10%) achieved CR with incomplete peripheral blood count recovery (CRi), for an overall response rate of 73%. Four 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 main grade ≥ 3 toxicity was mucositis in 8 patients (24%). No patients died during the initial 30-day induction period.
Patients were also assessed for response by baseline characteristics, including mutation status. Among them, 6 patients had a documented mutation in isocitrate dehydrogenase-2 (IDH2) and 8 patients in tumor protein 53 (TP53, or mutational p53). The overall response rate among evaluable patients with IDH2 and TP53 mutations was 100% (6/6) and 63% (5/8), respectively.
"We remain encouraged by this study's high response rates in older patients with AML and high-risk MDS, a population frequently resistant to or intolerant of therapy," said
"This study, which explores a novel combination with the hypomethylating agent decitabine, further supports the encouraging clinical profile of Qinprezo, a first-in-class, anti-cancer quinolone derivative," said Adam R. Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis. "As we prepare for unblinding of the pivotal Phase 3 VALOR trial in first relapsed or refractory AML, expected in the third or fourth quarter of 2014, we will continue to work closely with experienced investigators to explore Qinprezo's value within other segments of the AML and MDS disease spectrum."
For the trial, patients are treated with Qinprezo (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 a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Qinprezo 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, Qinprezo, 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 the VALOR trial and Sunesis' other clinical trials, the sufficiency of Sunesis' financial resources and the commercial potential for Qinprezo™ (vosaroxin). Words such as "anticipate," "approximately," "believe," "compelling," "continue," "could," "estimate," "expect," "explore," "potential," "remain," "suggest," "support," 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 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 Qinprezo, the risk that raising funds through lending arrangements may restrict our operations or produce other adverse results, 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, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the
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