Update Sustains Revumenib Benefit in R/R KMT2Ar Acute Leukemia
Updated results from the phase 2 AUGMENT-101 trial showed that revumenib continued to provide clinically meaningful responses in patients with relapsed or refractory acute leukemia. The trial, presented at the 2024 ASH Annual Meeting, demonstrated the efficacy of revumenib (Revuforj) in patients with relapsed or refractory acute leukemia with a KMT2Ar translocation.
The long-term durability of patient responses to revumenib was evident in the efficacy end points of minimal residual disease (MRD)-negativity and the percentage of procession to hematopoietic stem cell transplant (HSCT). The safety profile of revumenib remained manageable, with no patients discontinuing therapy due to differentiation syndrome or QTc prolongation.
Key Findings
As of the data cutoff of February 29, 2024, the overall response rate (ORR) was 63.9%, including a complete remission (CR) or a CR with partial hematologic recovery (CRh) rate of 22.7% and composite CR (CRc) of 42.3%. Of the responders, a significant percentage experienced MRD negativity.
The median duration of response (DOR) for responders was notable, with some patients remaining in follow-up without relapse or death. The median time to first response and the subsequent patient outcomes were also promising, indicating the potential of revumenib in this patient population.
Treatment and Safety
In the trial, patients received oral revumenib in 28-day cycles, with specific criteria for eligibility. The primary end points included CR and CRh rates, safety, and tolerability, while secondary end points focused on additional response metrics and treatment timelines.
The safety data revealed that grade 3 or higher treatment-related adverse events occurred in a significant percentage of patients, with manageable rates of dose reductions and discontinuations. The most common adverse events were febrile neutropenia, anemia, and QTc prolongation, among others.
Conclusion
The AUGMENT-101 trial highlighted the significance of revumenib as a targeted therapy for patients with relapsed or refractory KMT2Ar acute leukemia. The results underscore the need for effective treatments in this patient population, especially considering the challenges associated with relapse post-chemotherapy and HSCT.
In conclusion, the updated results from the trial reaffirm the clinical benefit of revumenib in patients with R/R KMT2Ar acute leukemia and pave the way for further advancements in the treatment landscape of this disease.
