Syndax announces data from multiple trials on revumenib

Syndax Pharmaceuticals announced data from multiple trials of revumenib in combination with standard of care agents in patients with nucleophosmin mutant and KMT2A-rearranged relapsed/refractory acute leukemias. Revumenib is the Company’s highly selective, oral menin inhibitor. SAVE AML Trial: Results from the SAVE AML trial of revumenib in combination with venetoclax-decitabine/cedazuridine in R/R AML were featured during an oral session at the 65th American Society of Hematology Annual Meeting. The dose escalation phase of the trial tested revumenib at doses of 113 mg and 163 mg every 12 hours in combination with azole antifungals known to strongly inhibit CYP3A4 enzymes. All nine patients attained a morphologic remission for an overall response rate of 100%, 78% of whom achieved a CRc1 including 44% who achieved a CR/CRh. 67% of patients in the trial attained minimal residual disease negative status. Five patients transitioned to hematopoietic stem-cell transplantation following response. Two patients initiated post-transplant maintenance with revumenib and continue in remission for over 11 months. The combination was well tolerated in this relapsed and refractory population, with no new safety signals observed beyond those reported for venetoclax-HMA. BEAT AML Trial: The Company also announced data from the BEAT AML trial of revumenib in combination with venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML patients. The dose escalation phase of the trial tested revumenib at doses of 113 mg and 163 mg q12h in combination with azole antifungals known to strongly inhibit CYP3A4 enzymes. As of the data cutoff date of December 1, 2023, 13 newly diagnosed mNPM1 or KMT2Ar AML patients were efficacy evaluable. In the efficacy evaluable population, the CRc was 100% after 1 – 2 cycles of induction. Eleven of 13 patients attained a CR/CRh and 92% attained MRD negative status. Two patients proceeded to transplant. No new safety signals were identified when revumenib was added to the standard venetoclax/azacitidine doublet in newly diagnosed AML patients. An expansion cohort is planned to further evaluate safety and activity of this combination, and the full BEAT AML data will be presented at a future medical conference. AUGMENT-102 Trial: The Company announced data from the AUGMENT-102 trial of revumenib in combination with fludarabine/cytarabine in a predominantly pediatric relapsed/refractory mNPM1, NUP98r and KMT2Ar AML population. As of the data cutoff date of September 20, 2023, 15 AML patients were efficacy evaluable, including three patients treated at 113 mg q12h and 12 patients treated at 163 mg q12h. Across both dose groups, 50% of patients had failed prior treatment with fludarabine/cytarabine. Among the 12 patients treated at 163 mg q12h, four patients achieved a CRc including three patients that achieved a CR; four proceeded to transplant, including one mNPM1 patient who received a five-day course of decitabine prior to transplant. The triplet of revumenib-fludarabine-cytarabine had an adverse event profile consistent with that observed with fludarabine-cytarabine alone, and no new safety signals were identified in the trial.