---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-302283"
form_type: "8-K"
ticker: "KURA"
cik: "0001422143"
company_name: "Kura Oncology, Inc."
filed_at: "2022-12-12T23:59:59+00:00"
generated_at: "2026-06-21T06:04:31.426552+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-22-302283
- form_type: 8-K
- ticker: KURA
- cik: 0001422143
- company_name: Kura Oncology, Inc.
- filed_at: 2022-12-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1422143/000119312522302283/0001193125-22-302283-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1422143/000119312522302283/d646465d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-302283
- JSON: https://secwatch.observer/filing/0001193125-22-302283.json
- Plain text: https://secwatch.observer/filing/0001193125-22-302283.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.