secwatch.observer — SEC 8-K summary
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Issuer:     Kura Oncology, Inc. (KURA)
CIK:        0001422143
Form:       8-K
Filed at:   2022-12-12T23:59:59+00:00
Accession:  0001193125-22-302283
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1422143/000119312522302283/0001193125-22-302283-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1422143/000119312522302283/d646465d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-302283

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