Kura Oncology reports ziftomenib 30% CR rate at 600 mg in NPM1-mutant AML; FDA agrees on registration-enabling trial

Kura Oncology, Inc.

Phase 1b trial at 600 mg showed 30% CR (6/20) in NPM1-mutant AML vs 17% at 200 mg; median duration of response not reached.
FDA Type C meeting confirmed 600 mg as recommended Phase 2 dose; agreement on key registration study design elements.
Phase 2 registration-directed trial expected to dose first patient in Q1 2023; combination studies with venetoclax/FLT3 planned.
Differentiation syndrome observed: 20% in NPM1-mutant patients at 600 mg (only 5% Grade 3); higher in KMT2A-rearranged patients.
No drug-induced QTc prolongation; six discontinuations none treatment-related; ziftomenib well tolerated overall.

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