On May 14, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported its abstract has been selected for a poster presentation at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting (EHA) (Free EHA Whitepaper) being held June 12-15 in Milan, Italy (Press release, Karyopharm, MAY 14, 2025, View Source [SID1234653063]). The abstract contains data on selinexor monotherapy in a hard-to-treat, heavily pretreated myelofibrosis patient population from the Phase 2 XPORT-MF-035 trial.

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"We are encouraged by our new data in hard-to-treat myelofibrosis patients where we observed spleen volume reduction, symptom improvement, hemoglobin stabilization and evidence of disease modification with selinexor monotherapy, addressing all four hallmarks of the disease," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "This new data adds to our growing body of evidence highlighting selinexor’s potential in patients with myelofibrosis."

The accepted abstract and data highlights are below.

Abstract number: PS1821
Title: A study to evaluate single-agent selinexor versus physician’s choice in participants with previously treated myelofibrosis
Date/Time: Saturday, June 14, 18:30-19:30 CEST
Presenter: Alessandro Lucchesi, MD
Highlights

Data from the XPORT-MF-035 (NCT04562870) Phase 2, randomized, open-label trial of selinexor versus physician’s-choice (PC) in hard-to-treat patients with heavily pretreated myelofibrosis indicated signs of single-agent clinical activity with selinexor, including spleen volume reduction, hemoglobin stabilization, symptom improvement and evidence of disease modification.
Patients were randomized 1:1 to either selinexor monotherapy or PC. Selinexor was administered at 80 mg weekly for the first two cycles and then decreased to 60 mg weekly from cycle 3 onwards. An optional crossover was available for PC treated patients if they met predefined spleen progression criteria.
In total, 12 patients were randomized to the selinexor arm and 12 patients to the PC arm; 6 patients crossed over from PC to selinexor. Inclusive of crossover, spleen volume reduction of 25% or more (SVR25) at anytime was achieved in 8/12 (67%) efficacy evaluable selinexor treated patients versus 3/8 (38%) efficacy evaluable patients treated with PC. Spleen volume reduction of 35% or more (SVR35) at anytime was observed in 4/12 (33%) efficacy evaluable patients treated with selinexor versus 1/8 (13%) efficacy evaluable patients treated with PC.
Patients treated with selinexor had higher mean hemoglobin levels throughout the study duration and lower rates of red blood cell transfusions than those treated with PC.
Data on key cytokines that are relevant to myelofibrosis pathogenesis, symptom development, and anemia including IL-6, IL-8, TNFa, and hepcidin, demonstrated greater reductions at week 4 compared to baseline in patients treated with selinexor than patients treated with PC.
Most common (≥25% overall) treatment emergent adverse events (TEAEs) in the randomized arms were decreased weight (selinexor: 50%; PC: 50%), anemia (25%; 58%), asthenia (42%; 25%), nausea (33%; 25%), thrombocytopenia (33%; 25%) and upper respiratory tract infection (25%; 33%). Most common (≥15% in any arm) Grade 3+ TEAEs were anemia (17%; 58%), cardiac failure (0%; 17%), decreased appetite (17%; 0%) and nausea (17%; 0%). No treatment discontinuations due to TEAEs were observed in the selinexor arm.
About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma; and (iii) under accelerated approval in adult patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations

Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

On May 14, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported the online publication of three abstracts submitted to the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, to be held June 12-15, 2025, Milan, Italy (Press release, Autolus, MAY 14, 2025, View Source [SID1234653087]). Autolus will have two oral and one poster presentation, which includes updated follow up from the FELIX study of obecabtagene autoleucel (obe-cel) in adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL).

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Oral S113:
Title: Can CAR T-cell therapy be a definitive treatment for adult r/r B-ALL without transplant? Long-term findings and predictors of sustained remission for obecabtagene autoleucel
Session Name: s447 Immunotherapy and CAR-T cells for ALL
Session room: Coral 6
Session Date and Time: Sunday, June 15; 11:00 – 12:15 CEST
Presenting Author: Jae H Park, MD

Summary: Obe-cel persistence, low disease burden at lymphodepletion and obe-cel use in earlier lines were independent factors associated with better outcomes and longer survival in adult pts with r/r B-ALL. At the current follow-up comprising patients studied for ≥3 years, 40% of responders are in ongoing remission without subsequent stem cell therapy or other new therapies, suggesting the potential of obe-cel as a definitive treatment for adult r/r B-ALL. An updated analysis with additional follow-up is underway and will be presented.

Oral S114:
Title: Efficacy and Safety Outcomes of Obecabtagene Autoleucel (obe-cel) Stratified by Age in Patients with r/r B-ALL
Session Name: Immunotherapy and CAR-T cells for ALL
Session Room: Coral 6
Session Date and Time: Sunday, June 15; 11:00 – 12:15 CEST
Presenting Author: Bijal D. Shah, MD

Summary: Obe-cel treatment was associated with deep and durable remissions resulting in favorable overall remission rate, event free survival, and overall survival with low incidence of Grade ≥3 CRS and ICANS in both age groups (<55 years and ≥55 years). These findings indicate that obe-cel is effective and has a positive benefit and risk profile regardless of patient age, including in older adults with R/R B-ALL, despite few patients receiving consolidative stem cell therapy.

Poster PF378:
Title: Predicting Hematotoxicity Risk and Outcomes in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-All): Should Hematotox Models be CAR Specific rather than Disease Specific
Session Title: Poster Session 1
Session date and time: Friday, June 13; 18:30 – 19:30 CEST.
Presenting Author: Claire Roddie, MD

Summary: Although both the CAR-Hematotox (CAR-HT) model, and the ALL-Hematotox (ALL-HT) model show potential, ALL-HT appears to improve risk stratification and may be a better predictor of response, survival and safety outcomes in adult patients with r/r B-ALL treated with obe-cel, than CAR-HT. Taken together with other published reports, our data suggest that the strength of HT-model predictions may be CAR specific. Further analyses are needed.

On May 14, 2025 Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, reported new advancements in its universal CAR-T cell therapy research, to be presented at the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Qihan Biotech, MAY 14, 2025, View Source [SID1234653102]).

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Through systematic exploration of T cell cytokine pathways, Qihan Biotech identified two novel cytokines that significantly enhance CAR-T cell activity. By engineering the corresponding receptor pathways, the company achieved robust CAR-T expansion in non-human primate models without lymphodepletion preconditioning and observable toxicity. This breakthrough offers a promising strategy to optimize CAR-T therapies and enables safer application in autoimmune diseases, paving the way for broader clinical use of CAR-T therapies.

Dr. Luhan Yang, Founder and CEO of Qihan Biotech, stated: "This research marks a significant step forward in CAR-T therapies. Enhancing CAR-T efficacy without lymphodepletion and toxicity could unlock its full potential in treating autoimmune diseases. We plan to begin clinical studies in 2025."

Poster Presentation Details:

Poster #1761: Enhanced CAR-T cell functions without lymphodepletion via engineering cytokine pathways

Session: Poster Abstract Session

Session Dates: May 13–15, 2025

On May 14, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Aprea, MAY 14, 2025, View Source [SID1234653049]).

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"2025 is off to a strong start with significant clinical progress across both of our lead therapeutic candidates," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "In our ongoing ATRN-119 clinical program, three patients in the latest twice daily cohort demonstrated stable disease, with tumor shrinkage of 7%, 14% and 21%, marking early evidence of single agent, anti-tumor activity. Notably, these encouraging results were achieved at a dose level below the recommended Phase 2 dose, reinforcing our belief in ATRN-119’s potential to address the urgent needs of patients with DDR-deficient cancers. As we progress to a dose level where clinical activity is emerging, our focus is shifting toward RP2D selection. Enrollment also continues in the ACESOT-1051 trial of our WEE1 inhibitor, APR-1051, and we expect to report preliminary efficacy data in the second half of 2025. At Aprea, we aim to redefine what is possible for patients with limited treatment options and we see ATRN-119 and APR-1051 as important clinical assets that may help us achieve this goal."

Key Business Updates and Potential Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in development. Aprea is advancing APR-1051 as monotherapy in cancers with well-defined biomarkers that may predict sensitivity to WEE1 inhibition. Among these, cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, lack effective therapies options.
Patients are now being enrolled into the 100 mg QD dose level in the ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) Phase 1 clinical trial evaluating single-agent APR-1051 in advanced solid tumors harboring cancer-associated gene alterations. Given the encouraging tolerability profile to date, we are in a position to accelerate dose escalation and explore higher doses, potentially improving APR-1051 therapeutic impact. Informed by pharmacokinetic (PK) data, the dose escalation in ACESOT-1051 has been revised to get to potential therapeutic levels of drug earlier. After successfully clearing the 100 mg once-daily dose level, patients in the next cohort are expected to be dosed at 150 mg. The first patient at the 70 mg once-daily dose level had HPV+ head and neck squamous cell carcinoma (HNSCC), in line with a clinical strategy to include populations most likely to benefit from WEEI inhibition.
The primary objectives of ACESOT-1051 are to assess safety, dose-limiting toxicities (DLTs), maximum tolerated dose or maximum administered dose (MTD/MAD), and determine recommended Phase 2 dose (RP2D); secondary objectives are to evaluate pharmacokinetics and preliminary efficacy according to RECIST or PCWG3 criteria; pharmacodynamic parameters are exploratory objectives.
Preliminary safety and efficacy data from the ACESOT-1051 study are anticipated in the second half of 2025, with completion of the dose-escalation phase expected in the first half of 2026. Aprea intends to submit an abstract to a major oncology conference.
For more information, refer to ClinicalTrials.gov NCT06260514.
ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed, to be used in patients with mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
ATRN-119 is being evaluated in the open-label Phase 1/2a clinical trial (ABOYA-119) as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes.
Six patients have demonstrated stable disease to date, with three patients in the 550 mg twice daily cohort showing tumor shrinkage of 7%, 14% and 21%. The individual results include:
A female patient with leiomyosarcoma harboring RB1/ATM mutations achieved a 21% tumor reduction at her first follow-up scan after two months of therapy.
A male patient with acinar cell carcinoma of the pancreas harboring ATM mutation experienced a 14% tumor reduction at his first follow-up scan.
A female patient with ovarian cancer harboring BRIP1 mutation showed a 7% tumor reduction at her first follow-up scan.
Importantly, these results were observed at a dose level that is below the recommended Phase 2 dose, as dose escalation continues in the trial.

Preliminary safety and efficacy data from ABOYA-119 are expected in the second half of 2025 and RP2D is expected to be identified in the first half of 2026. For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.
Material Transfer Agreement with MD Anderson Cancer Center

In March 2025, Aprea entered into a Material Transfer Agreement (MTA) with MD Anderson Cancer Center. Aprea has agreed to supply APR-1051 to support preclinical research aimed at exploring its potential in treating HPV+ and HPV- head and neck squamous cell carcinoma (HNSCC) expressing genomic markers of replication stress.
The agreement will enable the research group at MD Anderson to conduct a series of pre-clinical experiments designed to generate preliminary efficacy and mechanistic data to support future clinical trials and treatment regimens. The project is being overseen by Professors Jeffrey N. Myers, M.D., Ph.D., F.A.C.S., and Abdullah A. Osman, Ph.D., both from the Department of Head and Neck Surgery, MD Anderson Cancer Center. Prof. Myers is the leading expert on head and neck cancers.
Select Financial Results for the First Quarter Ended March 31, 2025

As of March 31, 2025, the Company reported cash and cash equivalents of $19.3 million compared to $22.8 million as of December 31, 2024. The Company believes its cash and cash equivalents as of March 31, 2025 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into early second quarter of 2026.
For the first quarter ended March 31, 2025, the Company reported an operating loss of $4.1 million, compared to an operating loss of $3.1 million in the first quarter of 2024.
Research and Development (R&D) expenses were $2.5 million for the quarter ended March 31, 2025, compared to $1.6 million for the first quarter of 2024. The increase in R&D expense was primarily related to the initiation of our second clinical trial program for APR-1051, our small molecule WEE1 inhibitor, and the ABOYA-119 clinical trial to evaluate ATRN-119, our clinical-stage oral small molecule inhibitor of ATR.
General and Administrative (G&A) expenses were $1.8 million for the quarter ended March 31, 2025, compared to $1.9 million for the first quarter of 2024.
The Company reported a net loss of $3.9 million ($0.66 per basic share) on approximately 6.0 million weighted-average common shares outstanding for the quarter ended March 31, 2025, compared to a net loss of $2.8 million ($0.67 per basic share) on approximately 4.2 million weighted average common shares outstanding for the comparable period in 2024.

On May 14, 2025 Kura Oncology, Inc. (Nasdaq: KURA, "Kura") and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that an abstract highlighting clinical data from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, has been accepted for presentation at the upcoming 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, to be held in Milan, Italy, from June 12-15, 2025 (Press release, Kura Oncology, MAY 14, 2025, View Source [SID1234653064]).

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KOMET-007 is a multicenter Phase 1 trial of ziftomenib in combination with standards of care, including cytarabine plus daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The data presented at EHA (Free EHA Whitepaper) will be from the Phase 1a dose-escalation and Phase 1b dose-expansion portions of the trial, in the cohort evaluating ziftomenib in combination with 7+3 in newly diagnosed patients with AML.

"The latest findings from the KOMET-007 trial underscore the potential of the combination of ziftomenib with intensive chemotherapy for newly diagnosed patients, strengthening our confidence in its role as a potential treatment option for a broad segment of the AML community," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "The Phase 1a/b KOMET-007 trial positions us to further evaluate this combination, and its potential to expand treatment options for AML patients, in the upcoming pivotal Phase 3 KOMET-017 trial."

In addition to the oral presentation, two abstracts for the KOMET-001 and KOMET-017 trials have been accepted for an encore presentation and publication, respectively. Session titles and information for all three abstracts are listed below and are now available on the EHA (Free EHA Whitepaper)web.org website. Updated data from the published abstract for KOMET-007 will be disclosed during the oral presentation.

Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1-m or KMT2A-r Acute Myeloid Leukemia (AML): Updated Phase 1a/b Results from KOMET-007
Session: s411. Menin inhibitors and venetoclax-based regimens in AML treatment
Date and Session Time: Thursday, June 12, 2025; 5:00PM – 6:15PM CEST
Location: Allianz MiCo, Milano Convention Centre, Auditorium
Publication Number: S136

Ziftomenib in Relapsed/Refractory NPM1-Mutant Acute Myeloid Leukemia: Phase 1b/2 Clinical Activity and Safety Results from the Pivotal KOMET-001 Study Session: Poster Session 1
Date and Time: Friday, June 13, 2025; 6:30 PM – 7:30 PM CEST
Location: Allianz MiCo, Milano Convention Centre, Poster Hall
Publication Number: PF473

Registrational Phase 3 Study of Ziftomenib in Combination with Non-Intensive or Intensive Chemotherapy for Newly Diagnosed NPM1-m and/or KMT2A-r Acute Myeloid Leukemia (AML): The KOMET-017 Trial
Online Publication Only
Publication Number: PB2573

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