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Kura Oncology and Kyowa Kirin Launch Clinical Trial Evaluating Dual Inhibition of NPM1 and FLT3 Mutations in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)
Globenewswire· 2025-10-01 11:01
Core Insights - Ziftomenib is being evaluated in combination with approved FLT3 inhibitors for frontline treatment of acute myeloid leukemia (AML) [1][2] - FLT3 mutations are prevalent in approximately 30% of newly diagnosed adult AML patients and up to 50% in those with NPM1-mutated AML, highlighting the significance of FLT3 as a target [1] - The KOMET-007 clinical trial has commenced, focusing on ziftomenib's efficacy alongside cytarabine, daunorubicin, and quizartinib for newly diagnosed AML patients [1][2] Company Overview: Kura Oncology - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors [4] - Ziftomenib, a menin inhibitor, is under development to address specific genetic drivers of acute myeloid leukemias [4] Company Overview: Kyowa Kirin - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [5] - The company is committed to developing novel medicines and treatments for high unmet medical needs, including hematological diseases and rare diseases [5]
Kura Oncology and Kyowa Kirin Launch Clinical Trial Evaluating Dual Inhibition of NPM1 and FLT3 Mutations in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)
Globenewswire· 2025-10-01 11:01
Core Insights - Ziftomenib is being evaluated in combination with approved FLT3 inhibitors for frontline treatment of acute myeloid leukemia (AML), addressing a significant unmet need in patients with FLT3/NPM1 co-mutations [1][2] - FLT3 mutations are prevalent in approximately 30% of newly diagnosed adult AML patients and up to 50% in those with NPM1-mutated AML, highlighting the importance of targeting this genetic alteration [1] - The KOMET-007 clinical trial has commenced, focusing on the safety and efficacy of ziftomenib combined with standard chemotherapy and quizartinib for newly diagnosed AML patients [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company dedicated to developing precision medicines for cancer treatment, with a focus on small molecule drug candidates targeting cancer signaling pathways [4] - Kyowa Kirin is a global specialty pharmaceutical company with over 70 years of experience in drug discovery and biotechnology innovation, aiming to develop novel therapies for high unmet medical needs [5] Clinical Development - Ziftomenib has received Breakthrough Therapy Designation from the FDA for treating adult patients with relapsed or refractory NPM1-mutated AML, indicating its potential significance in the treatment landscape [1] - The KOMET-007 trial will assess the combination of ziftomenib with intensive chemotherapy and quizartinib, with primary endpoints including complete remission and composite complete remission [2]