Syndax Pharma Posts Additional Data On Clinical Activity, Responses From Early-Stage Leukemia Trial

Syndax Pharmaceuticals Inc SNDX revealed updated data from the Phase 1 dose-escalation portion of the AUGMENT-101 trial of SNDX-5613 in patients with mutant nucleophosmin (mNPM1) or mixed-lineage leukemia rearranged (MLLr) relapsed/refractory acute leukemias.

  • The data were featured at the American Society of Hematology (ASH) Annual Meeting.
  • Across evaluable patients with mNPM1 (n=13) or MLLr (n=38) who received at least one dose of SNDX-5613, the overall response rate (ORR) was 55%, with a complete response with the partial hematologic recovery (CR/CRh) of 24%.
  • Nine patients proceeded to stem cell transplant. 
  • The ORR in evaluable patients harboring an NPM1 mutation was 38%, with a CR/CRh rate of 23%. 
  • The ORR in evaluable patients harboring an MLL-rearrangement was 61%, with a CR/CRh rate of 24%.
  • The overall minimal residual disease (MRD) negative rate was 31%. 
  • The median time to response to patients achieving a CR/CRh was two months. The median duration of response (DOR) was not reached.
  • SNDX-5613 was well-tolerated, with no discontinuations due to treatment-related adverse events observed in heavily pretreated patients. 
  • The only dose-limiting toxicity observed was Grade 3 QT prolongation. 
  • Differentiation syndrome was reported in 14% of patients, with all cases being mild or moderate and readily managed with standard therapies.
  • Related Link: Syndax Pharma, Incyte Ink Licensing Pact For Graft Vs. Host Disease Candidate.
  • Price Action: SNDX shares are trading 1.55% higher at $18.11 premarket on the lat check Tuesday.
  • Check out our coverage of the American Society of Hematology (ASH) Annual Meeting 2021 here.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareSmall CapGeneralASH21BriefsleukemiaPhase 1 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!