Revumenib continued to display promising anti-tumor activity in an updated analysis of the phase 2 AUGMENT-101 study among patients with relapsed or refractory KMT2A-rearranged (KMT2Ar) acute leukemia. Together with an acceptable safety profile and the possibility of a substantial proportion of patients continuing to HSCT, the results were clinically meaningful.
The phase 2 AUGMENT-101 study assessed the menin inhibitor revumenib in a population of patients with KMT2Ar acute leukemia1. The primary endpoints were safety and the rate of participants achieving complete remission (CR) + CR with partial hematological recovery (CRh). The safety population included 116 patients, and the efficacy population comprised 97 patients.
“Like in the previous interim analysis, revumenib showed promising efficacy data,” said Ibrahim Aldoss, MD, from the City of Hope, in California. The ORR was 63.9% and the CR + CRh rate was 22.7%. The median duration of CR + CRh response of the 22 participants who achieved this was 6.4 months; the updated median duration of CR + CRh response for the 13 participants who had reached this endpoint in the interim analysis was 13.0 months. Overall, it took the participants a median 2.0 months to reach CR + CRh. “With 33.9% of the treated participants able to proceed to HSCT for curative purposes, revumenib proved its value in this setting,” according to Dr. Aldoss.²
As for safety, about 5% of the participants discontinued revumenib due to treatment-related AEs. Febrile neutropenia (38.8%), anemia (19.8%), and decreased platelet count (16.4%) were the most common grade 3 or higher treatment-emergent AEs. “No new safety signals were reported and no participants discontinued treatment due to cytopenias, differentiation syndrome, or QTc prolongation,” Dr. Aldoss summarized.
In conclusion, in the phase 2 AUGMENT-101 study, revumenib was beneficial for heavily pre-treated patients with relapsed/refractory KMT2Ar acute leukemia regarding efficacy, whilst providing a manageable safety profile.
Medical writing support was provided by Robert van den Heuvel.
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