Kura Oncology to Present Updated Data from KOMET-007 Combination Trial of Ziftomenib at ASH Annual Meeting
Kura Oncology (KURA) announced two abstracts from the KOMET-007 combination trial of ziftomenib will be presented at the ASH Annual Meeting in San Diego (December 7-10, 2024). The trial combines ziftomenib with standard treatments in NPM1-mutant and KMT2A-rearranged acute myeloid leukemia (AML) patients.
Key highlights include: All four Phase 1a dose-escalation cohorts advanced to Phase 1b expansion at 600 mg; 100% of NPM1-m AML patients and 84% of KMT2A-r patients remained on study; No DLTs or ziftomenib-induced QTc prolongation reported. The data suggests promising safety profile and robust activity in combination with standard treatments.
Kura Oncology (KURA) ha annunciato che due abstract della sperimentazione KOMET-007 sul trattamento combinato con ziftomenib saranno presentati al ASH Annual Meeting di San Diego (dal 7 al 10 dicembre 2024). Lo studio combina ziftomenib con trattamenti standard in pazienti con leucemia mieloide acuta (AML) con mutazione NPM1 e riarrangiamento KMT2A.
I punti salienti comprendono: tutti e quattro i cohort di dose escalation di Fase 1a sono avanzati verso l'espansione di Fase 1b a 600 mg; il 100% dei pazienti con AML NPM1-m e l'84% dei pazienti con KMT2A-r sono rimasti nello studio; non sono stati segnalati DLTs o prolungamenti QTc indotti da ziftomenib. I dati suggeriscono un profilo di sicurezza promettente e una robusta attività in combinazione con i trattamenti standard.
Kura Oncology (KURA) anunció que se presentarán dos resúmenes del ensayo de combinación KOMET-007 con ziftomenib en la Reunión Anual de ASH en San Diego (del 7 al 10 de diciembre de 2024). El ensayo combina ziftomenib con tratamientos estándar en pacientes con leucemia mieloide aguda (AML) con mutaciones NPM1 y reordenamientos KMT2A.
Los puntos destacados incluyen: los cuatro cohortes de escalado de dosis de Fase 1a avanzaron a la expansión de Fase 1b a 600 mg; el 100% de los pacientes con AML NPM1-m y el 84% de los pacientes con KMT2A-r se mantuvieron en el estudio; no se informaron DLTs ni prolongación del QTc inducida por ziftomenib. Los datos sugieren un perfil de seguridad prometedor y una actividad robusta en combinación con tratamientos estándar.
Kura Oncology (KURA)는 ziftomenib의 KOMET-007 조합 시험에서 두 개의 초록을 발표할 예정이라고 발표했습니다. 이 발표는 샌디에이고에서 열리는 ASH 연례 회의(2024년 12월 7-10일)에서 이루어질 것입니다. 이 시험은 NPM1 변이가 있는 환자와 KMT2A 재배열 급성 골수성 백혈병 (AML) 환자에게 ziftomenib과 표준 치료를 조합합니다.
주요 내용은 다음과 같습니다: 네 개의 1a 단계 용량 상승 코호트가 600mg에서 1b 단계 확장으로 나아갔습니다; NPM1-m AML 환자의 100%와 KMT2A-r 환자의 84%가 연구에 남아 있었습니다; ziftomenib에 의해 유도된 DLT 또는 QTc 연장 보고가 없었습니다. 이 데이터는 표준 치료와의 조합에서 유망한 안전성 프로필과 강력한 활동을 제안합니다.
Kura Oncology (KURA) a annoncé que deux résumés de l'essai d'association KOMET-007 portant sur ziftomenib seront présentés lors de la Réunion Annuelle de l'ASH à San Diego (du 7 au 10 décembre 2024). L'essai combine le ziftomenib avec des traitements standards chez des patients atteints de leucémie myéloïde aiguë (LMA) avec mutation NPM1 et réarrangement KMT2A.
Les points clés incluent : les quatre cohortes d'escalade de dose de la phase 1a sont passées à l'expansion de la phase 1b à 600 mg ; 100 % des patients NPM1-m LMA et 84 % des patients KMT2A-r sont restés dans l'étude ; aucune DLT ni prolongation du QTc induite par le ziftomenib n'a été signalée. Les données suggèrent un profil de sécurité prometteur et une activité robuste en combinaison avec des traitements standards.
Kura Oncology (KURA) gab bekannt, dass zwei Abstracts aus der KOMET-007-Kombinationsstudie mit Ziftomenib auf dem ASH-Jahrestreffen in San Diego (vom 7. bis 10. Dezember 2024) vorgestellt werden. Die Studie kombiniert Ziftomenib mit Standardbehandlungen bei Patienten mit NPM1-mutierter und KMT2A-rearrangierter akuter myeloischer Leukämie (AML).
Zu den wichtigsten Punkten gehören: Alle vier Phasen-1a-Dosiserhöhungskohorten wurden auf Phase 1b bei 600 mg erweitert; 100 % der NPM1-m AML-Patienten und 84 % der KMT2A-r-Patienten blieben in der Studie; Es wurden keine DLTs oder QTc-Verlängerungen durch Ziftomenib berichtet. Die Daten deuten auf ein vielversprechendes Sicherheitsprofil und eine robuste Wirksamkeit in Kombination mit Standardbehandlungen hin.
- None.
- None.
– Ziftomenib combined with 7+3 in 1L NPM1-m or KMT2A-r adverse risk AML patients selected for oral presentation on Saturday, December 7th –
– Ziftomenib combined with ven/aza in R/R NPM1-m or KMT2A-r AML patients selected for poster presentation on Sunday, December 8th –
SAN DIEGO, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that two abstracts highlighting clinical data from the KOMET-007 combination trial of ziftomenib, the Company’s potent and selective menin inhibitor, have been accepted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting, to be held in San Diego from December 7-10, 2024.
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 ASH will be from the Phase 1a dose-escalation portion of the study, which was conducted in newly diagnosed patients with adverse risk in combination with 7+3 and in relapsed/refractory patients with ven/aza. Notably, all four cohorts in the Phase 1a dose-escalation portion of KOMET-007 have cleared the highest dose and have advanced into the Phase 1b expansion study at 600 mg.
“The growing body of clinical data continue to support a potential best-in-class safety and tolerability profile for ziftomenib, as well as robust and durable activity in combination with standards of care,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “In the relapsed/refractory AML setting, ziftomenib combined with ven/aza is well tolerated and continues to demonstrate encouraging activity in R/R patients, including activity in previously ven-exposed NPM1-m and KMT2A-r patients. No DLTs or ziftomenib-induced QTc prolongation were reported, and events of differentiation syndrome were mitigated in combination.”
“In the AML frontline population, we are very encouraged by the safety and tolerability profile and high rates of complete response and MRD negativity as of the abstract’s June 21st data cutoff,” Dr. Wilson continued. “We are particularly encouraged by the fact that, in the context of the very challenging 7+3 adverse risk AML patient cohorts,
Session titles and information for the two abstracts are listed below and are now available on the ASH online itinerary planner.
Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007
Session: 616. AML: Investigational Drug & Cellular Therapies: Menin Inhibitors in AML
Date and Time: Saturday, December 7, 2024; 2:00 - 3:30 PM PT
Oral Presentation Time: 2:45 PM PT
Location: San Diego Convention Center, Ballroom 20CD
Publication Number: 214
Ziftomenib Combined with Venetoclax/Azacitidine in Relapsed/Refractory NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET 007
Session: 616. AML: Investigational Drug & Cellular Therapies: Poster II
Date and Time: Sunday, December 8, 2024; 6:00 PM - 8:00 PM PT
Location: San Diego Convention Center, Halls G-H
Publication Number: 2880
Copies of the presentations will be available on Kura's website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.
About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-m AML. Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-m and KMT2A-r AML. Kura is evaluating KO-2806, a next-generation farnesyl transferase inhibitor (FTI), in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.
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 statements regarding, among other things, the efficacy, safety and therapeutic potential of ziftomenib, potential benefits of combining ziftomenib with appropriate standards of care, and progress and expected timing of the ziftomenib program and clinical trials. 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, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, 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 the Company faces, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission (SEC), including the Company’s Form 10-Q for the quarter ended June 30, 2024 filed with the SEC on August 8, 2024, 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.
Contacts
Investors:
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Executive Vice President, Investor Relations &
Corporate Communications
(858) 500-8833
pete@kuraoncology.com
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