Kura Oncology Cancer Study Hits Primary Goal, Lays Out Plans For Phase 3 Studies

Kura Oncology, Inc. KURA and Kyowa Kirin Co., Ltd released topline results from a Phase 2 registration-directed trial of ziftomenib for relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML).

What Happened: The KOMET-001 trial achieved its primary endpoint of complete response (CR) plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant.

The benefit-risk profile for ziftomenib is highly encouraging, and safety and tolerability were consistent with previous reports.

Topline data for KOMET-001 has been submitted for presentation at an upcoming medical conference in the second quarter of 2025. Kura looks to submit a new drug application (NDA) to the FDA for ziftomenib in the second quarter of 2025.

The companies also announced they plan to initiate a single protocol containing two independently powered, randomized, double-blind, placebo-controlled, registrational Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-m and KMT2A-rearranged (KMT2A-r) AML.

• The registrational KOMET-017-IC trial of intensive chemotherapy combination will assess minimum residual disease (MRD) negative CR and event-free survival (EFS) as dual-primary endpoints.
• The registrational KOMET-017-NIC trial of venetoclax / azacitidine combination will assess CR and overall survival (OS) as dual-primary endpoints.

The companies plan to initiate the two frontline Phase 3 trials in the second half of 2025 and anticipate multiple clinical data presentations for the ziftomenib AML program and Kura’s pipeline programs in 2025.

In November 2024, Kura Oncology and Kyowa Kirin entered into a global strategic collaboration to develop and commercialize ziftomenib for acute myeloid leukemia (AML) and other hematologic malignancies.

Under the agreement, Kura will receive an upfront payment of $330 million and expects to receive up to $420 million in near-term milestone payments.

Kura is eligible to receive additional milestone payments of $741 million. That’s a total of $1.161 billion in payments for milestones and the opt-in for solid tumor indications.

Price Action: Kura stock is down 8.84% at $8.25 at last check Thursday.

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