On May 22, 2025 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported 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) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago, IL from May 30 – June 3, 2025 (Press release, Kura Oncology, MAY 22, 2025, View Source [SID1234653309]).

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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 (Free ASCO Whitepaper) Annual Meeting in the coming weeks."

In addition to the oral presentation, a trial-in-progress abstract for the KOMET-015 trial has been accepted for poster presentation on May 31, 2025. Session titles and information for both abstracts are listed below and are now available on the ASCO (Free ASCO Whitepaper).org website. Updated data from the published abstract for KOMET-001 will be disclosed during the oral presentation.

Ziftomenib in Relapsed/Refractory (R/R) NPM1-Mutant Acute Myeloid Leukemia (AML): Phase 1b/2 Clinical Activity and Safety Results from the Pivotal KOMET-001 Study (#6506)
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: Monday, June 2, 2025; 3:00PM – 6:00PM CDT
Presentation Time: 4:36PM – 4:48PM CDT
Location: McCormick Place, S100a

Phase 1a/1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of Ziftomenib in Combination with Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure
Session: Poster Session – Sarcoma
Session Date and Time: Saturday, May 31, 2025; 9:00AM – 12:00PM CDT
Location: McCormick Place, Hall A – Posters and Exhibits

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.

Virtual Investor Event

Kura will host a virtual investor event featuring company management and investigators from the KOMET-001 trial of ziftomenib in R/R NPM1-m AML at 7:30pm ET / 4:30pm PT on Monday, June 2, 2025. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here.The event can also be accessed on the Investors section of Kura’s website at www.kuraoncology.com. An archived replay will be available shortly after the conclusion of the live event.