Kura Oncology and Kyowa Kirin Announce Publication in Blood of Ziftomenib plus Venetoclax / Azacitidine Combination in Patients with R/R NPM1-m AML
Rhea-AI Summary
Kura Oncology (Nasdaq: KURA) and Kyowa Kirin reported updated Phase 1a/b KOMET-007 data in relapsed/refractory NPM1-mutated AML using ziftomenib + venetoclax/azacitidine.
At 600 mg, venetoclax-naïve patients showed 87% ORR, 70% CRc and median OS not reached; venetoclax-experienced patients had 48% ORR, 24% CRc. The triplet showed a generally manageable safety profile with low differentiation syndrome and limited QTc events.
Positive
- Venetoclax-naïve, 600 mg: 87% ORR and 70% CRc (20/23 and 16/23)
- Venetoclax-naïve median CRc duration 9.2 months; median OS not reached at 10.7 months
- Venetoclax-experienced, 600 mg: 48% ORR and 24% CRc (12/25 and 6/25)
- MRD negativity in 75% of venetoclax-naïve and 50% of venetoclax-experienced CRc responders
- Triplet safety profile generally consistent with venetoclax/azacitidine alone
- Low differentiation syndrome rate 3% (2/67); single reversible ziftomenib-related QTc case
Negative
- Venetoclax-experienced group shows lower 24% CRc rate at 600 mg
- Venetoclax-experienced median OS 7.4 months at 9.9-month follow-up
- Ziftomenib + venetoclax/azacitidine remains investigational and is not FDA approved as a combination
- Findings are from early-stage Phase 1a/b trial with 64 response-evaluable patients
News Market Reaction – KURA
In the Jun 2 session, KURA declined 0.72%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 26 | Clinical trial update | Positive | -7.5% | Reported strong Phase 1a darlifarnib + adagrasib activity in KRAS G12C tumors. |
| May 19 | Conference participation | Neutral | +10.3% | Announced participation and fireside chat at TD Cowen oncology summit. |
| May 12 | Earnings and launch | Neutral | -2.1% | Reported Q1 2026 results and initial KOMZIFTI launch metrics with cash runway detail. |
| May 12 | Clinical data preview | Positive | +1.8% | Announced high CRc and MRD-negativity rates for ziftomenib + 7+3 at EHA 2026. |
| May 06 | Conference participation | Neutral | +2.9% | Disclosed participation in Bank of America healthcare conference with webcast access. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Positive clinical or strategic news has sometimes been met with negative or muted reactions, indicating occasional divergence between news tone and short-term price moves.
Over the past month, Kura reported multiple updates, including strong Phase 1a darlifarnib + adagrasib data on May 26, 2026 and encouraging KOMET-007 frontline ziftomenib/7+3 data on May 12, 2026. It also transitioned into a commercial-stage company with KOMZIFTI revenues in Q1 2026. Despite generally positive clinical and strategic developments, price reactions have varied, with at least one notable selloff following favorable clinical results, which rhymes with today’s negative move on positive combination data.
Key Terms
orr medical
measurable residual disease medical
mrd medical
qtc prolongation medical
phase 1a/b medical
flt3-itd medical
npm1-mutated medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
–
– Central MRD negativity in
– Median OS not reached after median follow up of 10.7 months in patients with no prior venetoclax exposure –
– Combination was well tolerated, with low rates of differentiation syndrome and QTc prolongation observed –
SAN DIEGO and TOKYO, June 02, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the publication in Blood of updated results from the relapsed/refractory (R/R) NPM1-mutated acute myeloid leukemia (NPM1-m AML) cohort of KOMET-007, a Phase 1a/b trial evaluating ziftomenib in combination with venetoclax and azacitidine (ven/aza). The publication reports nearly two-thirds of patients experienced clinically meaningful, deep and durable responses with a well-tolerated safety profile in adults with R/R NPM1-m AML.
KOMZIFTI™ (ziftomenib) is approved by the U.S. Food and Drug Administration as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Ziftomenib in combination with ven/aza is investigational and has not been approved by the FDA.
“This analysis provides a more mature evaluation of ziftomenib in combination with venetoclax and azacitidine in patients with NPM1-mutated AML,” said Eunice S. Wang, M.D., Chief of Leukemia, Roswell Park Comprehensive Cancer Center, and co-first senior author of the publication. “In the relapsed/refractory setting, outcomes with venetoclax-based regimens in patients with NPM1-mutant AML remain suboptimal, highlighting the substantial need for more effective therapies. These KOMET-007 results are notable for the depth and durability of response observed with the investigational three-drug combination. The favorable safety profile also supports the continued evaluation of this combination in a setting where better treatment options are urgently needed.”
“As combination approaches become increasingly important in this setting, the data highlighted in this publication strengthen the case for ziftomenib as a backbone in NPM1-mutant AML,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “Ziftomenib combined with ven/aza demonstrated deep molecular responses, durable remissions, and a generally manageable safety profile in R/R NPM1-m AML. These findings support our ongoing efforts to evaluate ziftomenib-based combinations across the treatment continuum, including in randomized studies designed to define the potential of ziftomenib in newly diagnosed disease.”
KOMET-007 Results in R/R NPM1-m AML
The data include 64 response-evaluable patients with R/R NPM1-m AML from the ongoing KOMET-007 Phase 1a/b trial (NCT05735184), 27 of whom were treated in phase 1a dose escalation and 37 of whom were treated in phase 1b expansion, as of the January 16, 2026 data cutoff date. Patients had received 1 to 8 prior lines of therapy (median of 1), and 37 patients (
Robust clinical activity was observed in patients with R/R NPM1-m AML across all ziftomenib dose levels, with nearly two-thirds of all patients experiencing clinically meaningful, deep, and durable responses. In addition, rapid responses were observed, with a median time to composite complete remission (CRc) of 3.9 weeks.
Venetoclax-Naïve Population (600 mg ziftomenib)
70% CRc rate (16/23) with75% (9/12) central measurable residual disease (MRD) negativity (<0.01% threshold), demonstrating deep molecular responses87% objective response rate (ORR) (20/23)- Median duration of CRc response of 9.2 months (
95% CI, 5.8-NE) - Median overall survival (OS) not reached after median follow-up of 10.7 months (N=25)
Venetoclax-Experienced Population (600 mg ziftomenib)
24% CRc rate (6/25) with50% (3/6) central MRD negativity (<0.01% threshold)48% ORR (12/25)- Median duration of CRc response of 8.6 months (
95% CI, 1.6-NE) - Median OS of 7.4 months after median follow-up of 9.9 months (N=26)
Safety in Both Populations at All Dose Levels (N=67)
- The triplet combination was well tolerated, with a safety profile consistent with that reported for ven/aza alone
- Low rates of differentiation syndrome (
3% , 2/67) observed with the protocol-specified staggered dosing schedule of ven/aza before menin inhibition; both events resolved with protocol-specified mitigation - One case of ziftomenib-related QTc; the event resolved without dose interruption or dose change
- Median time to neutrophil and platelet recovery were similar to ven-based regimens alone, supporting feasibility in combination regimens
“For people living with relapsed or refractory NPM1-mutated AML, the need for new treatment regimens remains significant,” said Yoshifumi Torii, Ph.D., Chief Medical Officer of Kyowa Kirin. “These published findings in the journal Blood add to our understanding of ziftomenib in combination with venetoclax and azacitidine and reinforce our shared commitment with Kura Oncology to advancing this program with urgency and rigor for patients who may benefit.”
The ongoing KOMET-007 Phase 1a/1b trial (NCT05735184) is evaluating ziftomenib in combination with ven/aza in multiple cohorts of newly diagnosed chemotherapy-ineligible AML and relapsed/refractory AML. The trial is also evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-m or KMT2A-rearranged (KMT2A-r) AML, as well as ziftomenib combined with quizartinib plus 7+3 intensive chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1-m co-mutations.
Kura and Kyowa Kirin are continuing to evaluate ziftomenib across multiple combination regimens and treatment settings, including in the ongoing pivotal KOMET-017 Phase 3 trials in newly diagnosed NPM1-m and KMT2A-r AML.
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.
About Ziftomenib
Ziftomenib, marketed in the United States as KOMZIFTI™, is a once-daily, oral menin inhibitor approved by the U.S. Food and Drug Administration as monotherapy 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 evaluated in clinical trials across the AML treatment continuum, including in combination with established treatment backbones, 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.
IMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING INFORMATION
Boxed WARNING: DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
KOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS is associated with rapid proliferation and differentiation of myeloid cells. Symptoms of DS, including those seen in patients treated with KOMZIFTI, may include fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, acute kidney injury, and rashes.
In the clinical trial, DS occurred in 29 (
In the 112 patients with an NPM1 mutation, DS was observed with and without concomitant hyperleukocytosis, in as early as 3 days and up to 46 days after KOMZIFTI initiation. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (
Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment.
QTc Interval Prolongation
KOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc interval prolongation was reported as an adverse reaction in
Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death.
Embryo-Fetal Toxicity
Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose.
ADVERSE REACTIONS
Fatal adverse reactions occurred in 4 (
Dosage interruption of KOMZIFTI due to an adverse reaction occurred in
Most common (≥
DRUG INTERACTIONS
Drug interactions may occur when KOMZIFTI is concomitantly used with:
- Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for KOMZIFTI-associated adverse reactions.
- Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI.
- Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting antacids. If concomitant use with H2RAs or locally acting antacids cannot be avoided, modify KOMZIFTI administration time.
- Take KOMZIFTI 2 hours before or 10 hours after administration of an H2 receptor antagonist.
- Take KOMZIFTI 2 hours before or 2 hours after administration of a locally acting antacid.
- Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI.
Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose.
Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential.
Please see full Prescribing Information, including Boxed WARNING.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of ziftomenib to serve as a combination backbone in NPM1-mutant AML. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, the risk that the collaboration with Kyowa Kirin is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Kura Contacts
Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com
Kyowa Kirin Contacts
Investors:
Ryohei Kawai
ir@kyowakirin.com
Media, Global:
Sachiko Kido
media@kyowakirin.com
