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Kyowa Kirin and Kura Oncology Initiate Japanese Phase 2 Registration-Directed Trial of Ziftomenib in R/R NPM1-m AML
– Regulatory Filing in Japan Planned Following Clinical Trial Completion –TOKYO and SAN DIEGO, April 24, 2026 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) and Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) today announced the first patient has been dosed in a Japanese Phase 2 registrational clinical trial (jRCT2031250550) studying ziftomenib, an oral menin inhibitor, for the treatment of relapsed or refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML). NPM1-m A
About this update from Kyowa Kirin Co., Ltd.
[{"type":"text","content":"– Regulatory Filing in Japan Planned Following Clinical Trial Completion –","length":74,"tagName":"p"},{"type":"text","content":"TOKYO and SAN DIEGO, April 24, 2026 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) and Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) today announced the first patient has been dosed in a Japanese Phase 2 registrational clinical trial (jRCT2031250550) studying ziftomenib, an oral menin inhibitor, for the treatment of relapsed or refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML). NPM1-m AML accounts for approximately 30% of AML patients. The initiation of this trial represents a significant step forward toward establishing a potential new treatment option for patients in Japan. Following completion of this clinical trial, Kyowa Kirin plans to file for regulatory approval in Japan.","length":724,"tagName":"p"},{"type":"text","content":"Ziftomenib was approved by the U.S. Food and Drug Administration (FDA) in November 2025 for the treatment of adult patients with R/R NPM1-m AML who have no satisfactory alternative treatment options, under the brand name KOMZIFTI™.","length":231,"tagName":"p"},{"type":"text","content":"“Patients with R/R NPM1-m AML often face limitations with existing treatment options and have a critical need for new therapeutic alternatives. Ziftomenib has the potential to provide a new treatment approach for these patients,” said Yoshifumi Torii, Ph.D., Chief Medical Officer of Kyowa Kirin. “The initiation of this trial is part of Kyowa Kirin's patient-centered drug development efforts in our priority area of 'hematologic malignancies and refractory hematologic disorders.' We will appropriately advance this trial and work diligently to confirm efficacy and safety, with the goal of ultimately providing a new treatment option to help address unmet needs for patients in Japan as soon as possible.”","length":720,"tagName":"p"},{"type":"text","content":"The trial initiated by Kyowa Kirin is a multicenter, single-arm, open-label Japanese Phase 2 clinical trial evaluating the efficacy and safety of ziftomenib in adult patients with R/R NPM1-m AML. As the primary endpoint, the trial will assess a composite complete remission rate consisting of complete remission (CR) and complete remission with partial hematologic recovery (CRh).","length":380,"ta...