SOUTH SAN FRANCISCO, Calif., June 2, 2014 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of Qinprezo™ (vosaroxin) in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The results will be presented today at the Leukemia, Myelodysplasia, and Transplantation General Poster Session of the American Society of Clinical Oncology Annual Meeting 2014 (ASCO) in Chicago, Illinois. The poster (Poster #383, S Hall A2) is titled "Phase I/II study of vosaroxin and decitabine in older patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)."
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 October 2013, following successful completion of a Phase 1b open-label, single-arm dose optimization phase. Patients in the ongoing trial are being followed for response, leukemia-free survival, overall survival and safety. Enrollment in the trial is ongoing.
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.