Skip to main content

Market Overview

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

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

Syndax Pharmaceuticals Inc (NASDAQ: SNDXrevealed 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.
 

Related Articles (SNDX)

View Comments and Join the Discussion!

Posted-In: ASH21 Briefs leukemiaBiotech News Health Care Small Cap General

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com