All-Oral Revumenib Regimen May Show Advantage in Newly Diagnosed AML

In a conversation with CancerNetwork® at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition, Wei Ying Jen, MA, BM BCh, M Med, MRCP, FRCPath, spoke about the quality of life implications and potential next steps for research following a presentation she gave on the phase 1/2 SAVE trial (NCT05360160).1 Data from the SAVE trial revealed that an all-oral combination of revumenib (Revuforj), decitabine /cedazuridine (Inqovi), and venetoclax (Venclexta) produced responses among patients with newly diagnosed acute myeloid leukemia (AML).

According to Jen, an assistant professor in the Department of Leukemia of the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, the all-oral revumenib-based regimen may provide an “advantage” for patients compared with undergoing chemotherapy in a standard hospital setting. However, because safety data revealed a concern for myelosuppression in the trial, she noted the importance of optimizing patient-specific dosing.

Jen described how results from a confirmatory phase 3 trial may affirm the benefits of revumenib-based treatment in the frontline setting, especially for those with KMT2A-rearranged disease.

In October 2025, the FDA approved revumenib monotherapy for patients with relapsed/refractory NPM1-mutated AML based on data from the phase 1/2 AUGMENT-101 trial (NCT04065399).2

Transcript:

For all oral regimens, especially in the continuation phase, being able to be at home and not having to sit in a chemotherapy chair to wait for your chemotherapy [and] to be prepared and [have it] given to you in the hospital setting is an advantage. We would like to say it is more tolerable, but it does also have myelosuppression. Clearly, optimization is important. But...once the patient-specific dose is arrived on, being able to take an oral regimen is very good for patients.

Hopefully, based on the results of the confirmatory phase 3 trial, we can start looking at revumenib in the front line, especially for patients with KMT2A-rearranged AML. For patients with NPM1 [mutations], we’ll still get answers from that trial. But for now, the labeled indication for revumenib is for relapsed/refractory KMT2A-rearranged or NPM1-mutated AML.

References

1. Jen W-Y, DiNardo CD, Short NJ, et al. Phase II study of the all-oral combination of revumenib (SNDX-5613) with decitabine/cedazuridine (ASTX727) and venetoclax (SAVE) in newly diagnosed AML. Blood. 2025;146(suppl 1):47. doi:10.1182/blood-2025-47
2. FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation. News release. FDA. October 24, 2025. Accessed December 7, 2025. https://tinyurl.com/2s5fenvy