The all-oral combination of revumenib with decitabine/cedazuridine and venetoclax exhibited acceptable safety and high efficacy in children and adults with relapsed or refractory acute myeloid leukemia (AML), according to a recent study.
The phase I/II, investigator-initiated trial was led by Ghayas Issa, MD, of the University of Texas MD Anderson Cancer Center.
Patients orally received decitabine/cedazuridine at 35 mg/100 mg daily for the first five days, venetoclax at 400 mg daily for the first 14 days, and revumenib at either 113 mg (dose level [DL] 0) or 163 mg (DL 1) every 12 hours for the first 28 days with either posaconazole or voriconazole. Of eight patients enrolled (median age, 27 years), six were at DL 0, and two were at DL 1. Dose escalation followed a 3+3 design.
The researchers performed bone marrow examination on day 14 of cycle one, and again at the end of the cycle, to assess for early morphologic remission and to determine future dose adjustments.
Of seven patients who were response-evaluable, all seven attained a morphologic remission, translating into a 100% overall response rate. One patient achieved complete remission (CR) plus resolution of extramedullary disease, one patient achieved CR with partial hematologic recovery, three patients achieved CR with incomplete platelet count recovery, one patient achieved partial response, and one patient achieved morphologic leukemia free state.
“This study is ongoing with plans to establish the recommended phase II dose and optimize delivery of this combination,” according to the researchers.
Issa G, Cuglievan B, DiNardo C, et al. Early results of the phase I/II study investigating the all-oral combination of the menin inhibitor revumenib (SNDX-5613) with decitabine/cedazuridine (ASTX727) and venetoclax in acute myeloid leukemia (SAVE). Abstract #58. Presented at the 65th ASH Annual Meeting and Exposition; December 9-12, 2023; San Diego, California.