AUGMENT-101: Revumenib trial in KMT2Ar leukaemia stopped early for efficacy

In a heavily pretreated population of participants with KMT2A rearranged (KMT2Ar) acute leukaemia, revumenib displayed encouraging anti-tumour activity. Moreover, the phase 2 study was terminated early for efficacy.

The investigational menin-KMT2A interaction inhibitor revumenib was tested in the phase 2 AUGMENT-101 trial (NCT04065399) among 94 participants with KMT2Ar acute leukaemia, either myeloid leukaemia (n=78) or lymphoblastic/mixed phenotype leukaemia (n=16). The participants had received a median of 2 lines of prior therapy. The primary outcomes were safety and the rate of complete remission (CR) plus CR with partial haematologic recovery (CRh). Dr Ibrahim Aldoss (City of Hope National Medical Center, CA, USA) presented the findings of the interim analysis [1].

After a median follow-up of 6.1 months, 23% of participants in the efficacy population (n=57) reached the primary endpoint of CR plus CRh (95% CI 12.7–35.8). The median duration of response was 6.4 months. The overall response rate was 63% and responses appeared consistent across participants with common co-mutations. Dr Aldoss mentioned that 70% of participants who reached CR plus CRh also achieved measurable residual disease negativity. Finally, 39% of the responders proceeded to haematopoietic stem cell transplant.

Grade ≥3 treatment-related adverse events were documented in 54% of the participants, with differentiation syndrome (16%), febrile neutropenia (14%), and QTc prolongation (14%) as the most commonly observed events of these higher grades. Dr Aldoss noted that 6% of the participants had discontinued therapy due to treatment-related adverse events.

Overall, revumenib provided high overall response rates, CR plus CRh rates, measurable residual disease negativity rates and the possibility to proceed to haematopoietic stem cell transplant in heavily pretreated participants with KMT2Ar leukaemia.

1. Aldoss I, et al. Revumenib monotherapy in patients with relapsed/refractory KMT2AR acute leukemia: topline efficacy and safety results from the pivotal AUGMENT-101 phase 2 study. S131, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 202412 August 2024