Syndax publishes SAVE trial data on Revuforj combination therapy in AML

Syndax Pharmaceuticals (NASDAQ: SNDX) announced that data from its SAVE trial studying an oral combination of Revuforj (revumenib), decitabine/cedazuridine, and venetoclax in relapsed/refractory acute myeloid leukemia patients was published in the Journal of Clinical Oncology.

The Phase 1/2 trial enrolled 42 patients with relapsed or refractory AML containing NPM1 mutations, KMT2A rearrangements, or NUP98 rearrangements. Patients had a median age of 40 years and received a median of two prior lines of therapy. The study reported an overall response rate of 88%, with 71% achieving composite complete remission and 60% achieving complete remission or complete remission with partial hematological recovery.

Among patients who achieved composite complete remission, 80% tested negative for measurable residual disease. The trial showed 45% of patients proceeded to stem cell transplant following treatment, with 63% of those patients resuming revumenib after transplant.

Response rates varied by patient subgroup. Patients without prior venetoclax exposure showed a 70% complete remission rate, while those previously exposed to venetoclax achieved a 50% rate. The median overall survival was 14 months for the entire cohort.

The combination therapy was generally well-tolerated, according to the study. The most common adverse events included liver enzyme elevations in 71% of patients, nausea in 52%, and vomiting in 48%. Grade 3 or higher adverse events included febrile neutropenia in 36% and lung infection in 21%.

Revuforj is currently the only FDA-approved menin inhibitor for treating relapsed or refractory AML with NPM1 mutations or KMT2A translocations in patients one year and older who lack satisfactory treatment alternatives.

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