Kura Oncology and Kyowa Kirin to Present Updated Frontline Ziftomenib / 7+3 Combination Data at EHA 2026 Congress – Oral presentation to feature 99-patient dataset with extended follow-up in newly diagnosed NPM1-m or KMT2A-r AML –
– High CRc rates (90–96%) with deep MRD negativity (> 80%) across both subtypes –
– Durable responses with median duration of CRc not reached in NPM1-m patients at ~15 months median follow-up –
– Phase 3 KOMET-017 trial currently enrolling with potential for accelerated FDA review in 2028 –

May 13, 2026

SAN DIEGO and TOKYO, May 12 and 13, 2026 – Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") today announced that updated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184) clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden.

The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML.

As of the abstract data cut-off on January 16, 2026:

High response rates across both molecular subtypes
- Composite complete response (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML
Deep molecular responses
- Measurable residual disease (MRD)-negativity rates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for KMT2A-r AML
Encouraging durability with extended follow-up
- Median follow-up of 14.9 months (NPM1-m) and 9.3 months (KMT2A-r)
- Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)
Consistent and manageable safety profile
- Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment
Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation

"With nearly 100 patients treated as well as extended follow-up, ziftomenib in combination with 7+3 continues to demonstrate consistently high response rates, deep MRD negativity, and encouraging durability across genetically defined AML subsets," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These data support our belief ziftomenib has potential to serve as a foundational backbone for frontline AML therapy, and we are advancing this regimen in our ongoing Phase 3 registrational program."

In addition to the oral presentation, abstracts for the KOMET-007 and KOMET-017 trials have been accepted for a poster presentation and online publication, respectively. Details are provided below and are available on the EHAweb.org website.

EHA 2026 Presentation Details: Title: Ziftomenib combined with intensive induction (7+3) for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the KOMET-007 trial

Session: s446 Novel treatments in AML

Date and Time: Sunday, June 14; 11:00-12:15 CEST

Location: Nobel Hall

Publication Number: S130; Title: Exposure-response analysis of ziftomenib combined with venetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia

Session: Poster Session 1

Date and Time: Friday, June 12; 18:45-19:45 CEST

Location: Poster Hall

Publication Number: PF537; Title: Registrational Phase 3 studies of ziftomenib in combination with nonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): The KOMET-017 trial

Location: Online Publication

Date and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST

Publication Number: PB2766

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

About Ziftomenib: Ziftomenib (marketed as KOMZIFTI™ in the U.S.) is a once-daily, oral menin inhibitor approved by the U.S. Food and Drug Administration for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Ziftomenib is being studied across the AML treatment continuum, including in combination studies in newly diagnosed and relapsed/refractory NPM1-mutated AML, KMT2A-rearranged AML, and FLT3-mutated AML. Ziftomenib is also being explored in additional oncology indications, including advanced gastrointestinal stromal tumors.

About Kura Oncology: Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura's pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

About Kyowa Kirin: Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology and rare diseases. A shared commitment to Kyowa Kirin's values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com.

Download