Revumenib

In the phase I/II AUGMENT-101 study (NCT04065399), 104 patients with relapsed or refractory acute leukemia with a KMT2A rearrangement received revumenib. Patients had to have a corrected QT interval (QTc) using Fridericia's formula of less than 450 milliseconds at baseline.[13]

In the phase I/II AUGMENT-101 study (NCT04065399), 104 patients with relapsed or refractory acute leukemia with a KMT2A rearrangement received revumenib. Patients had to have a corrected QT interval (QTc) using Fridericia's formula of less than 450 milliseconds at baseline.[13]

The overall rate of complete remission (CR) plus CRh (complete remission with partial hematologic recovery) was 21.2% (95% CI, 13.8%–30.3%). The median duration of CR plus CRh was 6.4 months (95% CI, 2.7–not reached).[13][Level of evidence C3]

In the phase I/II AUGMENT-101 study (NCT04065399), 104 patients with relapsed or refractory acute leukemia with a KMT2A rearrangement received revumenib. Patients had to have a corrected QT interval (QTc) using Fridericia's formula of less than 450 milliseconds at baseline.[13]

Of the 83 patients who were dependent on red blood cell and/or platelet transfusions, 14% became independent of transfusions during a 56-day postbaseline period.

In the phase I/II AUGMENT-101 study (NCT04065399), 104 patients with relapsed or refractory acute leukemia with a KMT2A rearrangement received revumenib. Patients had to have a corrected QT interval (QTc) using Fridericia's formula of less than 450 milliseconds at baseline.[13]

Revumenib has a boxed warning for differentiation syndrome, which was observed in 29% of patients. Grade 3 or 4 differentiation syndrome was observed in 13% of patients, and one patient died (0.7%).

In the phase I/II AUGMENT-101 study (NCT04065399), 104 patients with relapsed or refractory acute leukemia with a KMT2A rearrangement received revumenib. Patients had to have a corrected QT interval (QTc) using Fridericia's formula of less than 450 milliseconds at baseline.[13]

Grade 3 or higher QTc prolongation was observed in 12% of patients.

In the phase I/II AUGMENT-101 study (NCT04065399), 104 patients with relapsed or refractory acute leukemia with a KMT2A rearrangement received revumenib. Patients had to have a corrected QT interval (QTc) using Fridericia's formula of less than 450 milliseconds at baseline.[13]

Because revumenib is metabolized by CYP3A4, the dose must be reduced in patients receiving strong CYP3A4 inhibitors. The standard dose for patients who weigh more than 40 kg is 270 mg orally twice daily, with a dose reduction to 160 mg orally twice daily for patients receiving a strong CYP3A4 inhibitor. Furthermore, the dose is adjusted according to body surface area in patients who weigh less than 40 kg.