{"success":true,"data":{"pressRelease":{"id":"31774","rtpr_id":"nGNX8PRXTS","ticker":"KURA","exchange":"NASDAQ","all_tickers":["KURA"],"title":"Kura Oncology and Kyowa Kirin to Present Updated Frontline Ziftomenib / 7+3 Combination Data at EHA 2026 Congress ","author":"Globe Newswire","published_at":"2026-05-12T13:40:16.167Z","article_body":"– Oral presentation to feature 99-patient dataset with extended follow-up in\nnewly diagnosed NPM1-m or KMT2A-r AML –\n\n– High CRc rates (90–96%) with deep MRD negativity (> 80%) across both\nsubtypes –\n\n– Durable responses with median duration of CRc not reached in NPM1-m\npatients at ~15 months median follow-up –\n\n– Phase 3 KOMET-017 trial currently enrolling with potential for accelerated\nFDA review in 2028 –\n\n– Virtual Kura investor call on June 3 at 8:00 a.m. ET –\n\nSAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA)\nand Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that\nupdated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184)\nclinical trial evaluating ziftomenib in combination with cytarabine plus\ndaunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or\nKMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for\nan oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European\nHematology Association (EHA) Congress in Stockholm, Sweden.\n\nThe oral presentation will highlight updated results in 99 patients with newly\ndiagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in\ncombination with 7+3. These results represent one of the largest datasets\nreported to date for the evaluation of a menin inhibitor in combination with\nintensive chemotherapy in frontline AML.\n\nAs of the abstract data cut-off on January 16, 2026:\n* High response rates across both molecular subtypes * Composite complete\nresponse (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML\n \n* Deep molecular responses * Measurable residual disease (MRD)-negativity\nrates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for\nKMT2A-r AML\n \n* Encouraging durability with extended follow-up * Median follow-up of 14.9\nmonths (NPM1-m) and 9.3 months (KMT2A-r)\n* Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)\n\n \n* Consistent and manageable safety profile\n * Safety profile consistent across the NPM1-m and KMT2A-r groups with no new\nsafety signals observed with long-term treatment\n \n* Updated analyses with longer median follow-up, central MRD assessment,\ndurability outcomes, and deeper characterization of safety and hematologic\nrecovery will be included at the time of the oral presentation\n“With nearly 100 patients treated as well as extended follow-up, ziftomenib\nin combination with 7+3 continues to demonstrate consistently high response\nrates, deep MRD negativity, and encouraging durability across genetically\ndefined AML subsets,” said Mollie Leoni, M.D., Chief Medical Officer of Kura\nOncology. “These data support our belief ziftomenib has potential to serve\nas a foundational backbone for frontline AML therapy, and we are advancing\nthis regimen in our ongoing Phase 3 registrational program.”\n\nIn addition to the oral presentation, abstracts for the KOMET-007 and\nKOMET-017 trials have been accepted for a poster presentation and online\npublication, respectively. Details are provided below and are available on the\nEHAweb.org website.\n\nEHA 2026 Presentation Details\n\nTitle: Ziftomenib combined with intensive induction (7+3) for newly diagnosed\nNPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the\nKOMET-007 trial\nSession: s446 Novel treatments in AML\nDate and Time: Sunday, June 14; 11:00-12:15 CEST\nLocation: Nobel Hall \nPublication Number: S130\n\nTitle: Exposure-response analysis of ziftomenib combined with\nvenetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and\nrelapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia \nSession: Poster Session 1\nDate and Time: Friday, June 12; 18:45-19:45 CEST\nLocation: Poster Hall\nPublication Number: PF537\n\nTitle: Registrational Phase 3 studies of ziftomenib in combination with\nnonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r\nacute myeloid leukemia (AML): The KOMET-017 trial\nLocation: Online Publication \nDate and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST\nPublication Number: PB2766\n\nCopies of the presentations will be available on Kura’s website at\nwww.kuraoncology.com/pipeline/publications following presentation at the\nmeeting.\n\nVirtual Investor Event\nKura will host a webcast and conference call on June 3, 2026, at 8:00 am ET /\n5:00 am PT, featuring management and a clinical investigator from the\nKOMET-007 study. The live webcast and replay will be available on the\nCompany’s website at www.kuraoncology.com under the Investors tab in the\nEvents and Presentations section.\n\nAbout Kura Oncology \nKura Oncology is a biopharmaceutical company committed to realizing the\npromise of precision medicines for the treatment of cancer. Kura’s pipeline\nof small molecule drug candidates is designed to target cancer signaling\npathways and address high-need hematologic malignancies and solid tumors. Kura\ndeveloped and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved\nonce-daily, oral menin inhibitor for the treatment of adults with relapsed or\nrefractory NPM1-mutated acute myeloid leukemia, and continues to pioneer\nadvancements in menin inhibition and farnesyl transferase inhibition. For\nadditional information, please visit the Kura website\nat https://kuraoncology.com/ and follow us on X\n(https://www.globenewswire.com/Tracker?data=uXQ2S9k_MaQBQ0se2hQJsO2yQgsBQ8mef_d0Ju98bitkV1BTARc9SAIodPVXPUMjgBIcrneJ9lCVaoilwtW0j9EWGJRel7HUzm5H6v33jjTqKvMmLSPLabw6HfrEIgaajfpBF6x5ppAR7tZmnqRQeKiAMSgPAp70lKdI6XCVe-wLbDXWQu9PXmVBsM9k6fSyqgGgUifBW0-I2-iEnUxSJA==) and LinkedIn\n(https://www.globenewswire.com/Tracker?data=ztKk9eSnY6eILCZOREnxtr6PCZ2XNwdXUd71dSf7uJRNOtZfc42b1aExnACuauBIZa-JhBJhTaGJPytuHu8f5esghpRQN7-nS7I__gACQxE8Lj1AtdPNIR7iA1FtUCR0uTRaOBINSNgQTskcWpbXbbRHM-rIcZZPbWMkfzLQVbKPZ4-kOP3X8pypqmunGj8aUCaF09L_VatBjFDsKf_Hg32QDKEL2rdqbLAuSVryUqDVj70sXxukJ4_W20-cLrxQU3aauQVW_eKHkJXW4Yg1iw==).\n\nAbout Kyowa Kirin\nKyowa Kirin aims to discover and deliver novel medicines and treatments with\nlife-changing value. As a Japan-based Global Specialty Pharmaceutical Company,\nKyowa Kirin has invested in drug discovery and biotechnology innovation for\nmore than 70 years and is currently working to engineer the next generation of\nantibodies and cell and gene therapies with the potential to help patients\nwith high unmet medical needs, such as bone & mineral, intractable\nhematological diseases/hemato-oncology and rare diseases. A shared commitment\nto Kyowa Kirin’s values, to sustainable growth, and to making people smile\nunites Kyowa Kirin across the globe. You can learn more about the business of\nKyowa Kirin at www.kyowakirin.com.\n\nAbout Ziftomenib\nZiftomenib (marketed as KOMZIFTI™ in the U.S.) is a once-daily, oral menin\ninhibitor approved by the U.S. Food and Drug Administration for adult patients\nwith relapsed or refractory acute myeloid leukemia (AML) with a susceptible\nNPM1 mutation who have no satisfactory alternative treatment options.\nZiftomenib is being studied across the AML treatment continuum, including in\ncombination studies in newly diagnosed and relapsed/refractory NPM1-mutated\nAML, KMT2A-rearranged AML, and FLT3-mutated AML. Ziftomenib is also being\nexplored in additional oncology indications, including advanced\ngastrointestinal stromal tumors.\n\nIMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING\nINFORMATION\n\nBoxed WARNING: DIFFERENTIATION SYNDROME\n\nDifferentiation syndrome, which can be fatal, has occurred with KOMZIFTI.\nSigns and symptoms may include fever, joint pain, hypotension, hypoxia,\ndyspnea, rapid weight gain or peripheral edema, pleural or pericardial\neffusions, pulmonary infiltrates, acute kidney injury, and rashes. If\ndifferentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral\nor intravenous corticosteroids with hemodynamic and laboratory monitoring\nuntil symptom resolution; resume KOMZIFTI upon symptom improvement.\n\nWARNINGS AND PRECAUTIONS\n\nDifferentiation Syndrome\n\nKOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS\nis associated with rapid proliferation and differentiation of myeloid cells.\nSymptoms of DS, including those seen in patients treated with KOMZIFTI, may\ninclude fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or\nperipheral edema, pleural or pericardial effusions, acute kidney injury, and\nrashes.\n\nIn the clinical trial, DS occurred in 29 (26%) of 112 patients with R/R AML\nwith an NPM1 mutation who were treated with KOMZIFTI at the recommended\ndosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation\nof all patients with any genetic form of AML treated with KOMZIFTI monotherapy\nin clinical trials, DS occurred in 25% of patients. Four fatal cases of DS\noccurred out of 39 patients with KMT2A-rearranged AML treated with KOMZIFTI.\nKOMZIFTI is not approved for use in patients with KMT2A-rearranged AML.\n\nIn the 112 patients with an NPM1 mutation, DS was observed with and without\nconcomitant hyperleukocytosis, in as early as 3 days and up to 46 days after\nKOMZIFTI initiation. The median time to onset was 15 days. Two patients\nexperienced more than one DS event. Treatment was interrupted and resumed in\n15 (13%) patients, while it was permanently discontinued in 2 (2%) patients.\n\nPrior to starting treatment with KOMZIFTI, reduce the WBC counts to less than\n25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or\nintravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a\nminimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment\nwith KOMZIFTI at the same dose level when signs and symptoms improve and are\nGrade 2 or lower. Taper corticosteroids over a minimum of 3 days after\nadequate control or resolution of symptoms. Symptoms of DS may recur with\npremature discontinuation of corticosteroid treatment.\n\nQTc Interval Prolongation    \n\nKOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc\ninterval prolongation was reported as an adverse reaction in 12% of 112\npatients treated with KOMZIFTI at the recommended dosage for R/R AML with an\nNPM1 mutation. QTc interval prolongation was Grade 3 in 8% of patients. The\nheart-rate corrected QT interval (using Fridericia’s method) (QTcF) was\ngreater than 500 msec in 9% of patients, and the increase from baseline QTcF\nwas greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was\nrequired for 1% of patients due to QTc interval prolongation. QTc prolongation\noccurred in 14% of the 42 patients less than 65 years of age and in 10% of the\n70 patients 65 years of age or older.\n\nCorrect electrolyte abnormalities, including hypokalemia and hypomagnesemia,\nprior to treatment with KOMZIFTI. Perform an ECG prior to initiation of\ntreatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF >\n480 msec. Perform an ECG at least once weekly for the first four weeks on\ntreatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc\ninterval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In\npatients with congenital long QTc syndrome, congestive heart failure,\nelectrolyte abnormalities, or those who are taking medications known to\nprolong the QTc interval, more frequent ECG monitoring may be necessary.\nConcomitant use of KOMZIFTI with drugs known to prolong the QTc interval may\nincrease the risk of QTc interval prolongation, result in a greater increase\nin the QTc interval and adverse reactions associated with QTc interval\nprolongation, including Torsades de Pointes, other serious arrhythmias, and\nsudden death.\n\nEmbryo-Fetal Toxicity\n\nBased on findings in animals and its mechanism of action, KOMZIFTI can cause\nembryo-fetal harm when administered to a pregnant woman. Advise pregnant women\nof the potential risk to the fetus. Advise females of reproductive potential\nto use effective contraception during treatment with KOMZIFTI and for 6 months\nafter the last dose. Advise males with female partners of reproductive\npotential to use effective contraception during treatment with KOMZIFTI and\nfor 3 months after the last dose.\n\nADVERSE REACTIONS\n\nFatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI,\nincluding 2 with differentiation syndrome, 1 with infection, and 1 with sudden\ndeath. Serious adverse reactions were reported in 79% of patients who received\nKOMZIFTI. Serious adverse reactions occurring in ≥ 5% of patients included\ninfection without an identified pathogen (29%), febrile neutropenia (18%),\nbacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%).\n\nDosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of\npatients. Adverse reactions that required dose interruption in ≥ 2% of\npatients included infection without an identified pathogen (15%),\ndifferentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%),\nelectrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection\n(3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%),\nand thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction\noccurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an\nadverse reaction occurred in 21% of patients. Adverse reactions that required\npermanent discontinuation of KOMZIFTI in ≥ 2% of patients were infection\nwithout an identified pathogen (8%), bacterial infection (4%), cardiac arrest\n(2%), and differentiation syndrome (2%).\n\nMost common (≥ 20%) adverse reactions, including laboratory abnormalities,\nwere aspartate aminotransferase increased (53%), infection without an\nidentified pathogen (52%), potassium decreased (52%), albumin decreased (51%),\nalanine aminotransferase increased (50%), sodium decreased (49%), creatinine\nincreased (45%), alkaline phosphatase increased (41%), hemorrhage (38%),\ndiarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection\n(28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium\nincreased (26%), differentiation syndrome (26%), pruritus (23%), febrile\nneutropenia (22%), and transaminases increased (21%).\n\nDRUG INTERACTIONS\n\nDrug interactions may occur when KOMZIFTI is concomitantly used with:\n* Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for\nKOMZIFTI-associated adverse reactions.\n* Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI.\n* Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton\npump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting\nantacids. If concomitant use with H2RAs or locally acting antacids cannot be\navoided, modify KOMZIFTI administration time. * Take KOMZIFTI 2 hours before\nor 10 hours after administration of an H2 receptor antagonist.\n* Take KOMZIFTI 2 hours before or 2 hours after administration of a locally\nacting antacid.\n \n* Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If\nconcomitant use cannot be avoided, obtain ECGs when initiating, during\nconcomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc\ninterval is > 500 ms or the change from baseline is > 60 ms.\nUSE IN SPECIFIC POPULATIONS\n\nPregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI\ncan cause embryo-fetal harm when administered to a pregnant woman. Advise\npregnant women of the potential risk to a fetus. Verify pregnancy status in\nfemales of reproductive potential prior to starting KOMZIFTI.\n\nLactation: Because of the potential for adverse reactions in the breastfed\nchild, advise women not to breastfeed during treatment with KOMZIFTI and for 2\nweeks after the last dose.\n\nInfertility: Based on findings in animals, KOMZIFTI may impair fertility in\nfemales and males of reproductive potential.\n\nPlease see full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=uJg6glKTjOIz0yxzEPdlylQTeVIqCoSaApVfcsMwPwQKxZKjAMynZlS5-tpY4xo7bxzBVrsICepEkSVfdi0N6RO90OgLjIJpPLWDYofgxaBocif37tyDbc441kPyLjH2WE_ibStnSLLzEiTnt0s_Xg==),\nincluding Boxed WARNING.\n\nKura Forward-Looking Statements\n\nThis news release contains certain forward-looking statements that involve\nrisks and uncertainties that could cause actual results to be materially\ndifferent from historical results or from any future results expressed or\nimplied by such forward-looking statements. Such forward-looking statements\ninclude statements regarding, among other things, the potential of ziftomenib\nto serve as a foundational backbone for frontline AML therapy, the potential\nfor accelerated FDA review of data from Kura’s Phase 3 KOMET-017 trial, and\nthe expected timing and presentation of results and data from clinical trials.\nFactors that may cause actual results to differ materially include the risk\nthat compounds that appeared promising in early research or clinical trials do\nnot demonstrate safety and/or efficacy in later preclinical studies or\nclinical trials, the risk that Kura may not obtain approval to market its\nproduct candidates, uncertainties associated with performing clinical trials,\nregulatory filings, and other interactions with regulatory bodies, risks\nassociated with reliance on third parties to successfully conduct clinical\ntrials, the risks associated with reliance on outside financing to meet\ncapital requirements, the risk that the collaboration with Kyowa Kirin is\nunsuccessful, and other risks associated with the process of discovering,\ndeveloping and commercializing drugs that are safe and effective for use as\nhuman therapeutics, and in the endeavor of building a business around such\ndrugs. You are urged to consider statements that include the words “may,”\n“will,” “would,” “could,” “should,” “believes,”\n“estimates,” “projects,” “promise,” “potential,”\n“expects,” “plans,” “anticipates,” “intends,” “continues,”\n“designed,” “goal,” or the negative of those words or other comparable\nwords to be uncertain and forward-looking. For a further list and description\nof the risks and uncertainties the Company faces, please refer to the\nCompany's periodic and other filings with the Securities and Exchange\nCommission, which are available at www.sec.gov. Such forward-looking\nstatements are current only as of the date they are made, and Kura assumes no\nobligation to update any forward-looking statements, whether as a result of\nnew information, future events or otherwise.\n\nKura Contact\nGreg Mann (Investors and Media)\n858-987-4046\ngmann@kuraoncology.com\n\nKyowa Kirin Contacts\nRyohei Kawai (Investors)\nKyowa Kirin\nir@kyowakirin.com\n\nSachiko Kido (Media, Global)\nKyowa Kirin\nmedia@kyowakirin.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/ebf510d7-3727-4cc8-894f-6ce2d82b941a)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8PRXTS","title":"Kura Oncology and Kyowa Kirin to Present Updated Frontline Ziftomenib / 7+3 Combination Data at EHA 2026 Congress ","author":"Globe Newswire","ticker":"KURA","created":"2026-05-12T13:40:16.167Z","tickers":["KURA"],"exchange":"NASDAQ","article_body":"– Oral presentation to feature 99-patient dataset with extended follow-up in\nnewly diagnosed NPM1-m or KMT2A-r AML –\n\n– High CRc rates (90–96%) with deep MRD negativity (> 80%) across both\nsubtypes –\n\n– Durable responses with median duration of CRc not reached in NPM1-m\npatients at ~15 months median follow-up –\n\n– Phase 3 KOMET-017 trial currently enrolling with potential for accelerated\nFDA review in 2028 –\n\n– Virtual Kura investor call on June 3 at 8:00 a.m. ET –\n\nSAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA)\nand Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that\nupdated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184)\nclinical trial evaluating ziftomenib in combination with cytarabine plus\ndaunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or\nKMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for\nan oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European\nHematology Association (EHA) Congress in Stockholm, Sweden.\n\nThe oral presentation will highlight updated results in 99 patients with newly\ndiagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in\ncombination with 7+3. These results represent one of the largest datasets\nreported to date for the evaluation of a menin inhibitor in combination with\nintensive chemotherapy in frontline AML.\n\nAs of the abstract data cut-off on January 16, 2026:\n* High response rates across both molecular subtypes * Composite complete\nresponse (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML\n \n* Deep molecular responses * Measurable residual disease (MRD)-negativity\nrates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for\nKMT2A-r AML\n \n* Encouraging durability with extended follow-up * Median follow-up of 14.9\nmonths (NPM1-m) and 9.3 months (KMT2A-r)\n* Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)\n\n \n* Consistent and manageable safety profile\n * Safety profile consistent across the NPM1-m and KMT2A-r groups with no new\nsafety signals observed with long-term treatment\n \n* Updated analyses with longer median follow-up, central MRD assessment,\ndurability outcomes, and deeper characterization of safety and hematologic\nrecovery will be included at the time of the oral presentation\n“With nearly 100 patients treated as well as extended follow-up, ziftomenib\nin combination with 7+3 continues to demonstrate consistently high response\nrates, deep MRD negativity, and encouraging durability across genetically\ndefined AML subsets,” said Mollie Leoni, M.D., Chief Medical Officer of Kura\nOncology. “These data support our belief ziftomenib has potential to serve\nas a foundational backbone for frontline AML therapy, and we are advancing\nthis regimen in our ongoing Phase 3 registrational program.”\n\nIn addition to the oral presentation, abstracts for the KOMET-007 and\nKOMET-017 trials have been accepted for a poster presentation and online\npublication, respectively. Details are provided below and are available on the\nEHAweb.org website.\n\nEHA 2026 Presentation Details\n\nTitle: Ziftomenib combined with intensive induction (7+3) for newly diagnosed\nNPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the\nKOMET-007 trial\nSession: s446 Novel treatments in AML\nDate and Time: Sunday, June 14; 11:00-12:15 CEST\nLocation: Nobel Hall \nPublication Number: S130\n\nTitle: Exposure-response analysis of ziftomenib combined with\nvenetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and\nrelapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia \nSession: Poster Session 1\nDate and Time: Friday, June 12; 18:45-19:45 CEST\nLocation: Poster Hall\nPublication Number: PF537\n\nTitle: Registrational Phase 3 studies of ziftomenib in combination with\nnonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r\nacute myeloid leukemia (AML): The KOMET-017 trial\nLocation: Online Publication \nDate and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST\nPublication Number: PB2766\n\nCopies of the presentations will be available on Kura’s website at\nwww.kuraoncology.com/pipeline/publications following presentation at the\nmeeting.\n\nVirtual Investor Event\nKura will host a webcast and conference call on June 3, 2026, at 8:00 am ET /\n5:00 am PT, featuring management and a clinical investigator from the\nKOMET-007 study. The live webcast and replay will be available on the\nCompany’s website at www.kuraoncology.com under the Investors tab in the\nEvents and Presentations section.\n\nAbout Kura Oncology \nKura Oncology is a biopharmaceutical company committed to realizing the\npromise of precision medicines for the treatment of cancer. Kura’s pipeline\nof small molecule drug candidates is designed to target cancer signaling\npathways and address high-need hematologic malignancies and solid tumors. Kura\ndeveloped and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved\nonce-daily, oral menin inhibitor for the treatment of adults with relapsed or\nrefractory NPM1-mutated acute myeloid leukemia, and continues to pioneer\nadvancements in menin inhibition and farnesyl transferase inhibition. For\nadditional information, please visit the Kura website\nat https://kuraoncology.com/ and follow us on X\n(https://www.globenewswire.com/Tracker?data=uXQ2S9k_MaQBQ0se2hQJsO2yQgsBQ8mef_d0Ju98bitkV1BTARc9SAIodPVXPUMjgBIcrneJ9lCVaoilwtW0j9EWGJRel7HUzm5H6v33jjTqKvMmLSPLabw6HfrEIgaajfpBF6x5ppAR7tZmnqRQeKiAMSgPAp70lKdI6XCVe-wLbDXWQu9PXmVBsM9k6fSyqgGgUifBW0-I2-iEnUxSJA==) and LinkedIn\n(https://www.globenewswire.com/Tracker?data=ztKk9eSnY6eILCZOREnxtr6PCZ2XNwdXUd71dSf7uJRNOtZfc42b1aExnACuauBIZa-JhBJhTaGJPytuHu8f5esghpRQN7-nS7I__gACQxE8Lj1AtdPNIR7iA1FtUCR0uTRaOBINSNgQTskcWpbXbbRHM-rIcZZPbWMkfzLQVbKPZ4-kOP3X8pypqmunGj8aUCaF09L_VatBjFDsKf_Hg32QDKEL2rdqbLAuSVryUqDVj70sXxukJ4_W20-cLrxQU3aauQVW_eKHkJXW4Yg1iw==).\n\nAbout Kyowa Kirin\nKyowa Kirin aims to discover and deliver novel medicines and treatments with\nlife-changing value. As a Japan-based Global Specialty Pharmaceutical Company,\nKyowa Kirin has invested in drug discovery and biotechnology innovation for\nmore than 70 years and is currently working to engineer the next generation of\nantibodies and cell and gene therapies with the potential to help patients\nwith high unmet medical needs, such as bone & mineral, intractable\nhematological diseases/hemato-oncology and rare diseases. A shared commitment\nto Kyowa Kirin’s values, to sustainable growth, and to making people smile\nunites Kyowa Kirin across the globe. You can learn more about the business of\nKyowa Kirin at www.kyowakirin.com.\n\nAbout Ziftomenib\nZiftomenib (marketed as KOMZIFTI™ in the U.S.) is a once-daily, oral menin\ninhibitor approved by the U.S. Food and Drug Administration for adult patients\nwith relapsed or refractory acute myeloid leukemia (AML) with a susceptible\nNPM1 mutation who have no satisfactory alternative treatment options.\nZiftomenib is being studied across the AML treatment continuum, including in\ncombination studies in newly diagnosed and relapsed/refractory NPM1-mutated\nAML, KMT2A-rearranged AML, and FLT3-mutated AML. Ziftomenib is also being\nexplored in additional oncology indications, including advanced\ngastrointestinal stromal tumors.\n\nIMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING\nINFORMATION\n\nBoxed WARNING: DIFFERENTIATION SYNDROME\n\nDifferentiation syndrome, which can be fatal, has occurred with KOMZIFTI.\nSigns and symptoms may include fever, joint pain, hypotension, hypoxia,\ndyspnea, rapid weight gain or peripheral edema, pleural or pericardial\neffusions, pulmonary infiltrates, acute kidney injury, and rashes. If\ndifferentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral\nor intravenous corticosteroids with hemodynamic and laboratory monitoring\nuntil symptom resolution; resume KOMZIFTI upon symptom improvement.\n\nWARNINGS AND PRECAUTIONS\n\nDifferentiation Syndrome\n\nKOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS\nis associated with rapid proliferation and differentiation of myeloid cells.\nSymptoms of DS, including those seen in patients treated with KOMZIFTI, may\ninclude fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or\nperipheral edema, pleural or pericardial effusions, acute kidney injury, and\nrashes.\n\nIn the clinical trial, DS occurred in 29 (26%) of 112 patients with R/R AML\nwith an NPM1 mutation who were treated with KOMZIFTI at the recommended\ndosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation\nof all patients with any genetic form of AML treated with KOMZIFTI monotherapy\nin clinical trials, DS occurred in 25% of patients. Four fatal cases of DS\noccurred out of 39 patients with KMT2A-rearranged AML treated with KOMZIFTI.\nKOMZIFTI is not approved for use in patients with KMT2A-rearranged AML.\n\nIn the 112 patients with an NPM1 mutation, DS was observed with and without\nconcomitant hyperleukocytosis, in as early as 3 days and up to 46 days after\nKOMZIFTI initiation. The median time to onset was 15 days. Two patients\nexperienced more than one DS event. Treatment was interrupted and resumed in\n15 (13%) patients, while it was permanently discontinued in 2 (2%) patients.\n\nPrior to starting treatment with KOMZIFTI, reduce the WBC counts to less than\n25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or\nintravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a\nminimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment\nwith KOMZIFTI at the same dose level when signs and symptoms improve and are\nGrade 2 or lower. Taper corticosteroids over a minimum of 3 days after\nadequate control or resolution of symptoms. Symptoms of DS may recur with\npremature discontinuation of corticosteroid treatment.\n\nQTc Interval Prolongation    \n\nKOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc\ninterval prolongation was reported as an adverse reaction in 12% of 112\npatients treated with KOMZIFTI at the recommended dosage for R/R AML with an\nNPM1 mutation. QTc interval prolongation was Grade 3 in 8% of patients. The\nheart-rate corrected QT interval (using Fridericia’s method) (QTcF) was\ngreater than 500 msec in 9% of patients, and the increase from baseline QTcF\nwas greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was\nrequired for 1% of patients due to QTc interval prolongation. QTc prolongation\noccurred in 14% of the 42 patients less than 65 years of age and in 10% of the\n70 patients 65 years of age or older.\n\nCorrect electrolyte abnormalities, including hypokalemia and hypomagnesemia,\nprior to treatment with KOMZIFTI. Perform an ECG prior to initiation of\ntreatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF >\n480 msec. Perform an ECG at least once weekly for the first four weeks on\ntreatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc\ninterval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In\npatients with congenital long QTc syndrome, congestive heart failure,\nelectrolyte abnormalities, or those who are taking medications known to\nprolong the QTc interval, more frequent ECG monitoring may be necessary.\nConcomitant use of KOMZIFTI with drugs known to prolong the QTc interval may\nincrease the risk of QTc interval prolongation, result in a greater increase\nin the QTc interval and adverse reactions associated with QTc interval\nprolongation, including Torsades de Pointes, other serious arrhythmias, and\nsudden death.\n\nEmbryo-Fetal Toxicity\n\nBased on findings in animals and its mechanism of action, KOMZIFTI can cause\nembryo-fetal harm when administered to a pregnant woman. Advise pregnant women\nof the potential risk to the fetus. Advise females of reproductive potential\nto use effective contraception during treatment with KOMZIFTI and for 6 months\nafter the last dose. Advise males with female partners of reproductive\npotential to use effective contraception during treatment with KOMZIFTI and\nfor 3 months after the last dose.\n\nADVERSE REACTIONS\n\nFatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI,\nincluding 2 with differentiation syndrome, 1 with infection, and 1 with sudden\ndeath. Serious adverse reactions were reported in 79% of patients who received\nKOMZIFTI. Serious adverse reactions occurring in ≥ 5% of patients included\ninfection without an identified pathogen (29%), febrile neutropenia (18%),\nbacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%).\n\nDosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of\npatients. Adverse reactions that required dose interruption in ≥ 2% of\npatients included infection without an identified pathogen (15%),\ndifferentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%),\nelectrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection\n(3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%),\nand thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction\noccurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an\nadverse reaction occurred in 21% of patients. Adverse reactions that required\npermanent discontinuation of KOMZIFTI in ≥ 2% of patients were infection\nwithout an identified pathogen (8%), bacterial infection (4%), cardiac arrest\n(2%), and differentiation syndrome (2%).\n\nMost common (≥ 20%) adverse reactions, including laboratory abnormalities,\nwere aspartate aminotransferase increased (53%), infection without an\nidentified pathogen (52%), potassium decreased (52%), albumin decreased (51%),\nalanine aminotransferase increased (50%), sodium decreased (49%), creatinine\nincreased (45%), alkaline phosphatase increased (41%), hemorrhage (38%),\ndiarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection\n(28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium\nincreased (26%), differentiation syndrome (26%), pruritus (23%), febrile\nneutropenia (22%), and transaminases increased (21%).\n\nDRUG INTERACTIONS\n\nDrug interactions may occur when KOMZIFTI is concomitantly used with:\n* Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for\nKOMZIFTI-associated adverse reactions.\n* Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI.\n* Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton\npump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting\nantacids. If concomitant use with H2RAs or locally acting antacids cannot be\navoided, modify KOMZIFTI administration time. * Take KOMZIFTI 2 hours before\nor 10 hours after administration of an H2 receptor antagonist.\n* Take KOMZIFTI 2 hours before or 2 hours after administration of a locally\nacting antacid.\n \n* Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If\nconcomitant use cannot be avoided, obtain ECGs when initiating, during\nconcomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc\ninterval is > 500 ms or the change from baseline is > 60 ms.\nUSE IN SPECIFIC POPULATIONS\n\nPregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI\ncan cause embryo-fetal harm when administered to a pregnant woman. Advise\npregnant women of the potential risk to a fetus. Verify pregnancy status in\nfemales of reproductive potential prior to starting KOMZIFTI.\n\nLactation: Because of the potential for adverse reactions in the breastfed\nchild, advise women not to breastfeed during treatment with KOMZIFTI and for 2\nweeks after the last dose.\n\nInfertility: Based on findings in animals, KOMZIFTI may impair fertility in\nfemales and males of reproductive potential.\n\nPlease see full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=uJg6glKTjOIz0yxzEPdlylQTeVIqCoSaApVfcsMwPwQKxZKjAMynZlS5-tpY4xo7bxzBVrsICepEkSVfdi0N6RO90OgLjIJpPLWDYofgxaBocif37tyDbc441kPyLjH2WE_ibStnSLLzEiTnt0s_Xg==),\nincluding Boxed WARNING.\n\nKura Forward-Looking Statements\n\nThis news release contains certain forward-looking statements that involve\nrisks and uncertainties that could cause actual results to be materially\ndifferent from historical results or from any future results expressed or\nimplied by such forward-looking statements. Such forward-looking statements\ninclude statements regarding, among other things, the potential of ziftomenib\nto serve as a foundational backbone for frontline AML therapy, the potential\nfor accelerated FDA review of data from Kura’s Phase 3 KOMET-017 trial, and\nthe expected timing and presentation of results and data from clinical trials.\nFactors that may cause actual results to differ materially include the risk\nthat compounds that appeared promising in early research or clinical trials do\nnot demonstrate safety and/or efficacy in later preclinical studies or\nclinical trials, the risk that Kura may not obtain approval to market its\nproduct candidates, uncertainties associated with performing clinical trials,\nregulatory filings, and other interactions with regulatory bodies, risks\nassociated with reliance on third parties to successfully conduct clinical\ntrials, the risks associated with reliance on outside financing to meet\ncapital requirements, the risk that the collaboration with Kyowa Kirin is\nunsuccessful, and other risks associated with the process of discovering,\ndeveloping and commercializing drugs that are safe and effective for use as\nhuman therapeutics, and in the endeavor of building a business around such\ndrugs. You are urged to consider statements that include the words “may,”\n“will,” “would,” “could,” “should,” “believes,”\n“estimates,” “projects,” “promise,” “potential,”\n“expects,” “plans,” “anticipates,” “intends,” “continues,”\n“designed,” “goal,” or the negative of those words or other comparable\nwords to be uncertain and forward-looking. For a further list and description\nof the risks and uncertainties the Company faces, please refer to the\nCompany's periodic and other filings with the Securities and Exchange\nCommission, which are available at www.sec.gov. Such forward-looking\nstatements are current only as of the date they are made, and Kura assumes no\nobligation to update any forward-looking statements, whether as a result of\nnew information, future events or otherwise.\n\nKura Contact\nGreg Mann (Investors and Media)\n858-987-4046\ngmann@kuraoncology.com\n\nKyowa Kirin Contacts\nRyohei Kawai (Investors)\nKyowa Kirin\nir@kyowakirin.com\n\nSachiko Kido (Media, Global)\nKyowa Kirin\nmedia@kyowakirin.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/ebf510d7-3727-4cc8-894f-6ce2d82b941a)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-12T13:40:16.220679808Z","server_sent_at_ms":1778593216220},"received_at":"2026-05-12T13:40:16.376Z","source_url":null},"analysis":{"id":"23092","press_release_id":"31774","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Kura Oncology and partner Kyowa Kirin announced updated Phase 1 data for the frontline combination of ziftomenib and 7+3 chemotherapy in AML.\n\nThe 99-patient dataset showed high composite complete response rates of 96% in NPM1-mutant and 90% in KMT2A-rearranged patients, with MRD negativity exceeding 80% in both subtypes.\n\nDurability was encouraging, with median duration of CRc not reached at 14.9 months follow-up for NPM1-m patients, and the registrational Phase 3 KOMET-017 trial is currently enrolling.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Strong Phase 1 data shows 90%+ response rates in frontline AML; Phase 3 trial underway with accelerated review potential."},"keyFigures":{"drugName":"ziftomenib (KOMZIFTI)","phaseOfTrial":"Phase 1","customDimensions":{"patient_count":99,"crc_rate_npm1m":"96%","crc_rate_kmt2ar":"90%","mrd_negativity_npm1m":"83%","mrd_negativity_kmt2ar":"82%","median_follow_up_npm1m":"14.9 months","median_follow_up_kmt2ar":"9.3 months","median_duration_crc_npm1m":"not reached","median_duration_crc_kmt2ar":"11.2 months"}},"quotedText":"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","namedEntities":{"people":[{"name":"Mollie Leoni, M.D.","role":"Chief Medical Officer of Kura Oncology"},{"name":"Greg Mann","role":"Investors and Media Contact"},{"name":"Ryohei Kawai","role":"Investors Contact, Kyowa Kirin"},{"name":"Sachiko Kido","role":"Media Contact, Kyowa Kirin"}],"products":["ziftomenib","KOMZIFTI"],"companies":[{"name":"Kura Oncology, Inc.","ticker":"KURA"},{"name":"Kyowa Kirin Co., Ltd.","ticker":"4151","relationship":"partner"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Updated Phase 1 data shows high response rates (90-96% CRc) and deep MRD negativity (>80%) in a large dataset (99 patients) for the lead asset Ziftomenib. A Phase 3 registrational trial is enrolling with potential accelerated review in 2028. The data supports a strong commercial outlook."},"tickerRelevance":{"others":[{"ticker":"4151","relevance":"partner"}],"primary":"KURA"},"globalImportance":35,"audienceRelevance":45,"eventTypeSecondary":["partnership"],"importanceComponents":{"tickerTier":"mid-cap","partnerTier":"global pharma","eventGravity":"positive clinical data update","sectorWeight":"biotech"}},"event_type":"clinical_trial","event_type_secondary":["partnership"],"sentiment":"bullish","material_impact_score":4,"narrative":"Kura Oncology and partner Kyowa Kirin announced updated Phase 1 data for the frontline combination of ziftomenib and 7+3 chemotherapy in AML.\n\nThe 99-patient dataset showed high composite complete response rates of 96% in NPM1-mutant and 90% in KMT2A-rearranged patients, with MRD negativity exceeding 80% in both subtypes.\n\nDurability was encouraging, with median duration of CRc not reached at 14.9 months follow-up for NPM1-m patients, and the registrational Phase 3 KOMET-017 trial is currently enrolling.","key_figures":{"drugName":"ziftomenib (KOMZIFTI)","phaseOfTrial":"Phase 1","customDimensions":{"patient_count":99,"crc_rate_npm1m":"96%","crc_rate_kmt2ar":"90%","mrd_negativity_npm1m":"83%","mrd_negativity_kmt2ar":"82%","median_follow_up_npm1m":"14.9 months","median_follow_up_kmt2ar":"9.3 months","median_duration_crc_npm1m":"not reached","median_duration_crc_kmt2ar":"11.2 months"}},"named_entities":{"people":[{"name":"Mollie Leoni, M.D.","role":"Chief Medical Officer of Kura Oncology"},{"name":"Greg Mann","role":"Investors and Media Contact"},{"name":"Ryohei Kawai","role":"Investors Contact, Kyowa Kirin"},{"name":"Sachiko Kido","role":"Media Contact, Kyowa Kirin"}],"products":["ziftomenib","KOMZIFTI"],"companies":[{"name":"Kura Oncology, Inc.","ticker":"KURA"},{"name":"Kyowa Kirin Co., Ltd.","ticker":"4151","relationship":"partner"}],"dollarAmounts":[]},"model_name":"Qwen/Qwen2.5-72B-Instruct-AWQ","prompt_hash":"sha256:a76fb3b19e8e8b7b","schema_hash":"sha256:8658c370b800cf3d","created_at":"2026-05-12T13:42:41.351Z","global_importance":35,"audience_relevance":45,"importance_components":{"tickerTier":"mid-cap","partnerTier":"global pharma","eventGravity":"positive clinical data update","sectorWeight":"biotech"}},"durationMs":144991,"modelName":"george-droid-qwen-72b"}}