Core Insights - Kura Oncology has completed its first U.S. commercial sale of KOMZIFTI™ (ziftomenib), marking a significant milestone for the company [1] - The sale triggers a $135 million milestone payment from Kyowa Kirin, expected to be received by Kura before year-end [1] - KOMZIFTI was approved by the U.S. FDA on November 13, 2025, for treating adults with relapsed or refractory NPM1-mutated acute myeloid leukemia [1][2] Company Overview - Kura Oncology is focused on precision medicines for cancer treatment, with a pipeline of small molecule drug candidates targeting cancer signaling pathways [2] - The company is commercializing KOMZIFTI™, a once-daily oral menin inhibitor, and is advancing research in menin inhibition and farnesyl transferase inhibition [2]

Core Insights - KOMZIFTI (ziftomenib) is the first and only once-daily oral menin inhibitor approved by the FDA for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, now commercially available in the U.S. [1][2] - The drug has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines as a Category 2A recommended treatment option for this patient population [1][3] Company Overview - Kura Oncology, Inc. is a biopharmaceutical company focused on precision medicines for cancer treatment, with KOMZIFTI being a key product in its pipeline [19] - Kyowa Kirin Co., Ltd. is a global specialty pharmaceutical company with a long history in drug discovery and biotechnology innovation, collaborating with Kura on the commercialization of KOMZIFTI [20] Clinical Data - KOMZIFTI received full FDA approval on November 13, 2025, based on the KOMET-001 clinical trial, which demonstrated a 21.4% complete response (CR) or complete response with partial hematologic recovery (CRh) rate and a median duration of response of 5 months [2] - The clinical trial involved 112 patients with R/R AML and NPM1 mutation, with differentiation syndrome (DS) occurring in 26% of patients [8][14] Treatment Guidelines - The inclusion of KOMZIFTI in the NCCN Guidelines highlights its potential impact on patients with R/R NPM1-mutated AML and reflects the commitment to patient access [3] - KOMZIFTI is also being developed for front-line treatment of AML with various mutations, indicating its potential to benefit a broader patient population [5] Safety Information - KOMZIFTI has a boxed warning for differentiation syndrome, which can be fatal, and requires monitoring and management protocols [6][7] - Adverse reactions reported in clinical trials include serious reactions in 79% of patients, with the most common being infections and differentiation syndrome [14][16]

Core Insights - The FDA has granted full approval for KOMZIFTI (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, marking it as the first once-daily oral menin inhibitor approved for this indication [1][11] - The approval is based on the KOMET-001 trial, which demonstrated a complete remission rate of 21.4% and a median duration of response of 5.0 months in patients with R/R NPM1-m AML [5][6] - KOMZIFTI is positioned to address a significant unmet need in a patient population with historically poor outcomes and limited treatment options [1][4] Company Overview - Kura Oncology, in collaboration with Kyowa Kirin, is committed to advancing the development of KOMZIFTI across the treatment continuum for AML, aiming to improve patient outcomes [2][8] - The companies have established a global strategic collaboration for the development and commercialization of KOMZIFTI, with Kura leading efforts in the U.S. [8] Clinical Data - In the pivotal KOMET-001 trial, 112 patients were evaluated, with 88% of those achieving complete remission or complete remission with partial hematologic recovery within 6 months of treatment initiation [5][6] - The trial also reported a median time to first response of 2.7 months, indicating a rapid onset of efficacy [5] Safety Profile - KOMZIFTI has a favorable safety profile, with no Boxed Warning related to QTc prolongation or Torsades de Pointes, which is significant for patients on multiple concurrent medications [6][7] - The most common adverse reactions included increased liver enzymes and infections, with serious adverse reactions reported in 79% of patients [21][23] Market Potential - The approval of KOMZIFTI represents a major advancement in targeted therapies for AML, particularly for patients who are older and unable to tolerate intensive chemotherapy [6][8] - The drug's once-daily oral administration and compatibility with other medications enhance its potential to become the preferred treatment option in its approved indication [2][6] Access and Support - Kura has established a support program, Kura RxKonnect, to facilitate access and reimbursement for patients prescribed KOMZIFTI [9]