Eytan M. Stein, MD, Assistant Attending Physician, and Director, Program for Drug Development in Leukemia, Department of Medicine at Memorial Sloan Kettering Cancer Center, and the trial’s principal investigator speaks about Syndax Announces Positive Interim Data Demonstrating Robust Clinical Activity in Phase 1 Portion of the AUGMENT-101 Trial of SNDX-5613 in Patients with Genetically-Defined Acute Leukemias.
Link to Clinical Trial:
https://clinicaltrials.gov/ct2/show/NCT04065399?term=AUGMENT-101+SNDX-5613&draw=2&rank=1
Link to Article:
https://ir.syndax.com/news-releases/news-release-details/syndax-announces-positive-interim-data-demonstrating-robust
Modified promising results from the Phase 1 dose-escalation section of the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant relapsed/refractory (R/R) acute leukemias were released today by a clinical-stage biopharmaceutical firm building an advanced portfolio of cancer therapies. SNDX-5613 is a highly selective oral menin inhibitor developed by the company. The live video webcast and accompanying slide show can be accessed using the information provided below.
The Phase 1 portion of the AUGMENT-101 study had dosed 43 patients with a total of three previous treatments, such as prior stem cell transplant, venetoclax, and chemotherapy, as of a March 12, 2021 data cutoff date. At the time of the data cutoff date, 31 patients were evaluable for effectiveness, with the remaining patients either not yet at their original efficacy evaluation (n=4) or not having the MLLr or NPM1c mutation (n=8). The average response rate1 (ORR) among evaluable patients was 48% (n=15), with 67 percent (n=10) of these responders reaching MRD negative status and four of these patients undergoing stem cell transplantation. The ORR was 54 percent (n=13) in evaluable patients with an MLL-rearrangement (n=24), and 29 percent (n=2) in evaluable patients with an NPM1c mutation (n=7).
For patients who are not receiving a concomitant strong CYP3A4 inhibitor, a candidate RP2D of 226 mg every 12 hours was identified, and for patients who are receiving a concomitant strong CYP3A4 inhibitor, a candidate RP2D of 113 mg every 12 hours was identified. Eighteen patients treated at the RP2D were efficacy-evaluable, and the RP2D reaction outcomes were comparable to the general population.
SNDX-5613 was relatively well-tolerated in all patients involved in the study as of the data cutoff date (n=43), with no discontinuations due to treatment-related adverse reactions found in heavily pretreated patients. QT prolongation, anemia, and differentiation syndrome were the only category 3 or higher associated adverse effects that occurred in at least 5% of cases. As of the data cutoff date, 9% of all patients treated at the nominee RP2D (n=22) had grade 3 QT prolongation.