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 ( KURA ) 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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