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ASH 2025 | Phase II SAVE study of revumenib-based all-oral therapy in newly diagnosed AML
Wei-Ying Jen, MA, BM BCh, M Med, MRCP, FRCPath, The University of Texas MD Anderson Cancer Center, Houston, TX, shares results of the Phase II SAVE study (NCT05360160) evaluating the all-oral combination of revumenib, decitabine/cedazuridine (ASTX727), and venetoclax in newly diagnosed, unfit patients with NPM1-mutated or KMT2A-rearranged acute myeloid leukemia (AML). Dr Jen highlights the encouraging efficacy data, with a high overall response rate (ORR) and measurable residual disease (MRD) negativity rate. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So we did a Phase II study in frontline patients who were ineligible for intensive chemotherapy. They had to have either a KMT2A rearrangement, a NUP98 rearrangement, or NPM1 mutations. We didn’t have anyone with a NUP98 rearrangement in this cohort. There were 21 patients in total, about 2/3 NPM1 and 1/3 KMT2A. The overall response rate was very good. It was over 80% with a CR rate of also over 80%...
So we did a Phase II study in frontline patients who were ineligible for intensive chemotherapy. They had to have either a KMT2A rearrangement, a NUP98 rearrangement, or NPM1 mutations. We didn’t have anyone with a NUP98 rearrangement in this cohort. There were 21 patients in total, about 2/3 NPM1 and 1/3 KMT2A. The overall response rate was very good. It was over 80% with a CR rate of also over 80%. We did have two people who had a cycle 1 day 14 bone marrow which showed, which is no leukemia in the bone marrow, but unfortunately they died due to complications of infection and bleeding before the end of cycle 1 bone marrow. In terms of the MRD negative rate, all patients were MRD negative by flow cytometry. By the more sensitive NPM1 PCR, just over 2/3 were negative at any time point. It seems that most patients will become negative by the end of cycle 2, but an increasing number become negative with time. The duration of remission was also pretty good. More than 70% were still in remission at one year, but clearly, as we spoke about, you know, there are concerns about myelosuppression which need to be addressed in terms of the dosing.
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