On March 24, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the first patients have been treated in the investigator-sponsored VITAL (Vosaroxin and Infusional Cytarabine for Frontline Treatment of Acute Myeloid Leukemia) Phase 2 study of vosaroxin in combination with cytarabine in patients with previously untreated acute myeloid leukemia (AML) (Press release, Sunesis, MAR 24, 2016, View Source [SID:1234509918]). Schedule your 30 min Free 1stOncology Demo! The trial is being conducted at the Vanderbilt-Ingram Cancer Center at Vanderbilt University under the direction of Michael R. Savona, M.D., FACP, Associate Professor of Medicine and Director of Hematology Early Therapeutics Program, and Stephen A. Strickland, M.D., MSCI, Assistant Professor of Medicine.
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"With an alarming rate of mortality in AML and no major change in induction therapy strategy for nearly four decades, there is an urgent need to find novel therapeutic strategies for this disease," said Dr. Strickland. "Given the established, acceptable safety profile of infusional cytarabine given concomitantly with vosaroxin, this combination offers a new approach for achieving remission in this population. It also provides the opportunity to expand upon the previously observed efficacy of vosaroxin in patients with relapsed/refractory AML and has the potential to serve as a foundation for a future randomized Phase 3 trial."
VITAL, a single-arm, open-label Phase 2 trial will enroll up to 61 previously untreated, newly diagnosed adult patients with AML. During stage 1 of the trial, 17 patients will be enrolled. The study design permits one interim look to examine evidence of futility after the first 17 patients are evaluable for response. If ≤ 7 patients achieve complete remission (CR), the VITAL DSMB will review the clinical data to determine the merits of continued enrollment. If > 7 CRs are observed, the second stage will open automatically and increase enrollment to 41 patients. During both stages, Vosaroxin will be administered intravenously at 90 mg/m2 on days 1 and 4. Cytarabine will be administered in standard fashion as a continuous infusion of 100 mg/m2 daily on days 1-7.
Patients with evidence of residual leukemia on "Day 14 biopsy" following initial induction will be offered re-induction with intravenous vosaroxin at 70 mg/m2 on days 1 and 4 in combination with continuous infusion cytarabine at 100 mg/m2 daily on days 1-7. The primary endpoint of the study is rate of CR. The secondary endpoints are to determine the safety and tolerability, presence of minimal residual disease, CR (including CR with incomplete blood count recovery), neutrophil and platelet recovery, disease free survival (DFS), overall survival (OS), and the correlation of HSCT comorbidity index and Wheatley index scores with disease response, DFS and OS.
"VITAL is the third investigator-sponsored combination trial of vosaroxin in frontline AML, and an important component of establishing our future development strategy in this setting," said Daniel Swisher, Chief Executive Officer of Sunesis. "We look forward to seeing results from these studies, which include two other leading institutions, MD Anderson and Indiana University, as we make progress on the review of our European Marketing Authorization Application for vosaroxin as a treatment for relapsed/refractory AML."
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 vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.