Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vosaroxin · 7 trials · 10 indications
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
Efficacy assessments
Combined remission rate (complete remission \[CR\] + complete remission with incomplete platelet recovery \[CRp\]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set. Per IWG criteria, a CR requires bone marrow blasts \< 5%, absolute neutrophil count (ANC) \> 1000 cells/uL, and platelet (plt) count \> 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count \<= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.
Defined as the highest dose of vosaroxin that results in a DLT in =\< 1 of 6 patients graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Maximum tolerated dose of vosaroxin for short IV infusion in INT-2 or high-risk MDS
Maximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which \<33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy. This will define severe and delayed myelosuppression not related to persistent leukemia and likely related to treatment.
| Arm | Type | Description |
|---|---|---|
| Group A: vosaroxin + cytarabine | EXPERIMENTAL | vosaroxin (short IV infusion within 10 minutes) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation |
| Group B: placebo + cytarabine | PLACEBO_COMPARATOR | placebo (short IV infusion within 10 minutes and volume matched to vosaroxin) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation |
| Azacitidine + Vosaroxin | OTHER | Cycle 1-8: Azacitidine: 75 mg/m²/d subcutaneously, d 1-7; Vosaroxin: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 . Patients who have completed 8 cycles of azacitidine and vosaroxin are scheduled to maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression. |
| All Study Patients | EXPERIMENTAL | * Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15 * Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8 * Schedule C: 72 mg/m2 on Days 1 and 4, or * Schedule C: 90 mg/m2 on Days 1 and 4 |
| Treatment (vosaroxin, azacitidine) | EXPERIMENTAL | Patients receive vosaroxin IV over 10 minutes on days 1 and 4 and azacitidine SC or IV over 15 minutes on days 1-7. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Vosaroxin: All Patients | EXPERIMENTAL | All patients will receive vosaroxin according to the dose cohort in which they are enrolled. |
| Vosaroxin + Decitabine | EXPERIMENTAL | The first 6 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5). Following the phase I portion, patients in phase II receive the following induction: 1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I. 2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I. |
| Sch A (18 mg/m2 vosaroxin initially) | EXPERIMENTAL | Once weekly intravenous on days 1, 8, 15 up to 4 cycles |
| Sch B (9 mg/m2 vosaroxin initially) | EXPERIMENTAL | Twice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles |
| Name | Type | Description |
|---|---|---|
| vosaroxin + cytarabine | DRUG | Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles Cytarabine 1 g/m2 daily on days 1-5 (IDAC) |
| placebo + cytarabine | DRUG | Placebo days 1 and 4: volume matched to vosaroxin Cytarabine 1 g/m2 daily on days 1-5 (IDAC) |
| Vosaroxin | DRUG | Cycle 1-8: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 . |
| Azacitidine | DRUG | Cycle 1-8 Azacitidine: 75 mg/m²/d subcutaneously, d 1-7; Maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression. |
| Decitabine | DRUG | Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5). |
Inclusion Criteria: * Provided signed, written informed consent * At least 18 years of age * Had a diagnosis of AML according to World Health Organization (WHO) classification * First relapsed or refractory AML (refractory to initial induction therapy) with at least 5% blasts by bone marrow or aspi...
Vosaroxin is an investigational small molecule being studied for the treatment of acute myeloid leukemia, myelodysplastic syndromes, and other leukemias. It is in Phase 3 clinical development for these oncology indications.
Vosaroxin is a small molecule therapeutic being developed for oncology indications. Its specific molecular target has not been disclosed in the available information.
Vosaroxin is being developed by Viracta Therapeutics, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol VIRX.
Vosaroxin is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. It is being studied for acute myeloid leukemia and myelodysplastic syndromes.
Vosaroxin has been studied in several clinical trials, including NCT00246662, NCT01913951, NCT01980056, and NCT03338348. These trials have been completed and include Phase 1 and Phase 2 studies in leukemia and myelodysplastic syndromes.
Vosaroxin was previously known as SNS-595. An early clinical trial, NCT00246662, evaluated SNS-595 for the treatment of hematologic malignancies, including acute leukemias and myelodysplastic syndromes.