ASH 2023: Revumenib Combined With Decitabine/Cedazuridine And Venetoclax For Relapsed Or Refractory AML

A Phase 1/2 Study

Early results of a phase 1/2 study covering the use of revumenib (previously known as SNDX-5613) combined with decitabine/cedazuridine and venetoclax were presented at the ASH 2023 Conference held in December. This study (NCT05360160) was designed for children and adults, to treat the KMT2A and NPM1 gene mutations. Revumenib is a potent, selective inhibitor of KMT2A that has shown promising results for relapse or refractory AML. 

Revumenib

“Acute leukemia occurs when menin interacts with KMT2A, driving cell behavior during the immature phase, causing the cells’ failure to differentiate and become active. When this happens, the immature cells also take the space of healthy cells. Revumenib targets menin to disrupt the interaction that triggers this process, allowing the immature ones to become actually mature, healthy, functioning cells.”

Medication Administration

The dose escalation process of this study was the following:

• Decitabine/cedazuridine was administered at 35 mg/100 mg daily on days 1-5.
• Venetoclax was administered at 400mg daily on days 1-14.
• Revumenib was administered at 113mg daily on days 1-28.
• Maintenance revumenib is planned as a monotherapy after stem cell transplant.

Study Side Effects

The median age of this study was 27 years old (the range was 12-62 years old). Most patients had tried 2.5 prior treatment options. The most common side effects:

• 63% experienced febrile neutropenia (a temperature over 101.3).
• 63% experienced hyperphosphatemia (too much phosphate in your blood, which can cause kidney disease).
• 63% experienced nausea.
• 25% experienced AST/ALT elevation (may be a sign of liver problems).
• 25% experienced decreased platelet count (may have trouble stopping bleeding).
• 25% experienced decreased neutrophil count (a type of white blood cells that help fight infection).

Study Results

Bone marrow blasts decreased an average of 66% to 8%. And 100% of patients experienced morphologic remission (a disappearance of all cells with characteristics of cancer). Measurable residual disease was undetectable in 43% of patients. Several transitioned to a stem cell transplant and some are now in remission. This study is ongoing.

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