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Kura Oncology and Kyowa Kirin Announce Pivotal Monotherapy Data for Ziftomenib in Oral Presentation at the 2025 ASCO Annual Meeting
– Results from KOMET-001 registration-directed trial of ziftomenib in R/R NPM1-m AML patients selected for oral presentation on Monday, June 2nd – – Encore
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– Results from KOMET-001 registration-directed trial of ziftomenib in R/R NPM1-m AML patients selected for oral presentation on Monday, June 2nd – – Encore presentation planned at EHA 2025 Congress – – Kura Oncology to host virtual investor event at 7:30pm ET / 4:30pm PT on June 2nd to discuss the trial results – SAN DIEGO and TOKYO, May 22, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that an abstract highlighting the full data analyses from the KOMET-001 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, has been accepted for oral presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago, IL from May 30 - June 3, 2025. The KOMET-001 registration-directed trial (NCT #04067336) is designed to assess evidence of clinical activity, safety and tolerability of ziftomenib, the only investigational therapy to receive Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for treatment of relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). NPM1 mutations are among the most common, representing approximately 30% of AML cases, and there are no FDA approved therapies for NPM1-m AML. Kura and Kyowa Kirin previously announced positive topline results from the KOMET-001 trial, which achieved its primary endpoint of complete remission (CR) plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. Ziftomenib was well‑tolerated with limited myelosuppression and 3% ziftomenib-related discontinuations. The benefit-risk profile for ziftomenib is highly encouraging, and safety and tolerability were consistent with previous reports. “These data highlight ziftomenib’s potential use as a treatment option for R/R NPM1-mutant AML,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We are encouraged by the safety and tolerability profile as well as the clinical efficacy observed for this subset of AML patients, and together, Kura and Kyowa Kirin are committed to advancing ziftomenib toward commercialization. We look forward to sharing a more comprehensive dataset at the ASCO Annual Meeting in the coming weeks.” In additio...