A MENIN INHIBITOR STUDY

FOR PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA

EXPERT PERSPECTIVES ON AML LATEST KOMET-001 DATA

ABOUT KOMET-001

The goal of the Phase 2 registration-enabling expansion is to assess evidence of clinical activity, safety, and tolerability of ziftomenib in patients with relapsed or refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML).

CONTACT US REQUEST A MSL CALL STUDY LOCATIONS LATEST KOMET-001 DATA

ABOUT ZIFTOMENIB

Ziftomenib, an oral investigational drug candidate, is a novel compound targeting the menin-KMT2A (MLL) interaction for treatment of genetically defined AML patients with high unmet need. In preclinical models, ziftomenib inhibits the KMT2A (MLL) protein complex and has downstream effects on HOXA9/MEIS1 expression.

  • Epigenetic modifications by the menin-KMT2A (MLL) complex lead to expression of HOXA9/MEIS1, which leads to proliferation, stemness and differentiation block.1
  • These KMT2A (MLL) rearrangements alter normal histone methyltransferase function of KMT2A (MLL), resulting in sustained high HOX levels and blockage of hematopoietic differentiation, ultimately leading to acute leukemia.1-3
  • Mutant NPM1 is also dependent on the interaction between menin and wild-type KMT2A (MLL) to drive leukemogenic gene expression.1
  • Ziftomenib is an investigational small molecule inhibitor of the menin-KMT2A (MLL) complex that may inhibit the survival, growth, and proliferation of certain kinds of leukemia cells as demonstrated in vitro.4

NPM1–m AML

have NPM1 mutation with or without other gene mutations5,6

  • Phase 1 (dose escalation and expansion) is complete
  • Phase 2 will evaluate the RP2D (600 mg QD) in patients with R/R NPM1-m AML
  • Objectives are to assess evidence of clinical activity, safety, and tolerability

STUDY LOCATIONS

Please select a location to see sites near you

Regions

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  • France
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International Sites

  • France
  • Germany
  • Italy
  • Spain

United States Sites

  • Arizona
  • California
  • Florida
  • Illinois
  • Indiana
  • Maryland
  • Massachusetts
  • Michigan
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AOU di Bologna – Policlinico di Saint’Orsola-Malpighi

Bologna, Italy, 40138

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Contact: BMDACCResearch@bannerhealth.com   

Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69495

CHU de Lille

Lille, France, 59000

CHU de Nantes

Nantes, France, 44000

Duke Cancer Institute

Durham, North Carolina, United States, 27710

Contact: hematologyresearch@duke.edu

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Contact: Lumi Demirovic 551-996-8154 Ljumnije.demirovic@hmhn.org   

Harold C. Simmons Comprehensive Cancer Center – UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Contact: Yasmeen Akhtar, MBBS,MS,CCRP 214-648-5130 Yasmeen.Akhtar@UTSouthwestern.edu

Hopital Saint Louis

Paris, France, 75475

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Hospital Universitari Vall d’Hebron

Barcelona, Spain 08035

Hospital Universitario Central de Asturias

Oviedo, Spain, 33011

Hospital Universitario HM Sanchinarro

Madrid, Spain, 28050

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

Institut Gustave Roussy

Villejuif, France, 94800

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Contact: Emily Tolksdorf 313-576-9814 tolksdoe@karmanos.org

Magendie Hopital Haut-Leveque

Pessac, France, 33600

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Contact: Christine Connolly CCONNOLLY1@mgh.harvard.edu   

Mayo Clinic

Rochester, Minnesota, United States, 55905

Contact: Cancer Center Clinical Trials Referral Office 855-776-0015   

Mayo Clinic

Jacksonville, Florida, United States, 32224

Contact: 507-538-3365      

Mayo Clinic

Phoenix, Arizona, United States, 85054

Contact: Joshua Sandolo 480-574-2296 Sandolo.Joshua@mayo.edu

MD Anderson Cancer Center

Madrid, Spain, 28033

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Contact: Rachel Abramowicz rrabramo@mdanderson.org

Medizinische Hochsschule Hannover

Hannover, Germany

Northwestern University

Chicago, Illinois, United States, 60611

Contact: jillian.weeks@northwestern.edu

Oklahoma University Health – Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73117

Contact: Silas Day Silas-Day@ouhsc.edu

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14203

Contact: askroswell@roswellpark.org   

The Mount Sinai Hospital

New York, New York, United States, 10029

Contact: Tina Czaplinska 212-241-3659 Tina.czaplinska@mssm.edu   

UCLA Bowyer Oncology Center

Los Angeles, California, United States, 90095

Contact: Bruck Habtemariam   BHabtemariam@mednet.ucla.edu   

Universitat de Barcelona

Barcelona, Spain 08035

University Medicine Greifswald

Greifswald, Germany, 17475

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Contact: Larissa Sanglard, MD 410-328-8370 larissa.sanglard@umm.edu   

University of Michigan Hospitals

Ann Arbor, Michigan, United States, 48109

Contact: 800-865-1125 canceranswerline@med.umich.edu   

University of Southern California

Los Angeles, California, United States, 90033

Contact: Christine Duran 323-865-0371 duran_c@med.usc.edu   

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Contact: Felicia Kass kassfe2@upmc.edu   

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Contact: Recruitment and Eligibility Office 800-811-8480 cip@vumc.org   

Weill Cornell Medical College – NY Presbyterian Hospital

New York, New York, United States, 10021

Contact: Tania Curcio 212-746-2571 tjc9003@med.cornell.edu

STUDY LOCATIONS

All 39 /2020 0 /2021 0 /2022 0 /2023 0 /AIM 0 /Arizona 2 /Australia 0 /Austria 0 /Awards 0 /Belgium 0 /California 0 /California 2 /California 0 /Currents 0 /Denmark 0 /Fathi 0 /Florida 0 /Florida 1 /Florida 0 /France 6 /Georgia 0 /Germany 0 /Germany 2 /Global 0 /Global 16 /Greece 0 /Illinois 1 /Imagery 0 /Indiana 1 /Italy 0 /Italy 1 /Kansas 0 /Kentucky 0 /Komet 38 /Kura Kommentary 0 /Kurrent 0 /Leadership 0 /Leadership In The News 0 /Life at Kura 0 /Malaysia 0 /Maryland 0 /Maryland 1 /Maryland 0 /Massachusetts 0 /Massachusetts 1 /Massachusetts 0 /Media Coverage 0 /Michigan 0 /Michigan 2 /Minnesota 0 /Minnesota 1 /Missouri 0 /Missouri 0 /Netherlands 0 /New Jersey 1 /New York 0 /New York 3 /New York 0 /North Carolina 0 /North Carolina 1 /Norway 0 /Office 0 /Oklahoma 0 /Oklahoma 1 /Pennsylvania 0 /Pennsylvania 1 /Pennsylvania 0 /Perspectives 0 /Republic of Korea 0 /Spain 0 /Spain 7 /Taiwan 0 /Tennessee 0 /Tennessee 1 /Texas 2 /Texas 0 /Thailand 0 /Type 0 /United Kingdom 0 /United States 0 /United States 22 /United States 0 /videos 0 /Washington 0 /Washington 1 /Wisconsin 0 /Wisconsin 0 /Year 0 /Zeidan 0

AOU di Bologna – Policlinico di Saint’Orsola-Malpighi

Bologna, Italy, 40138

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69495

CHU de Lille

Lille, France, 59000

CHU de Nantes

Nantes, France, 44000

Duke Cancer Institute

Durham, North Carolina, United States, 27710

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Harold C. Simmons Comprehensive Cancer Center – UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Hopital Saint Louis

Paris, France, 75475

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Hospital Universitari Vall d’Hebron

Barcelona, Spain 08035

Hospital Universitario Central de Asturias

Oviedo, Spain, 33011

Hospital Universitario HM Sanchinarro

Madrid, Spain, 28050

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

Institut Gustave Roussy

Villejuif, France, 94800

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Magendie Hopital Haut-Leveque

Pessac, France, 33600

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Mayo Clinic

Rochester, Minnesota, United States, 55905

Mayo Clinic

Jacksonville, Florida, United States, 32224

Mayo Clinic

Phoenix, Arizona, United States, 85054

MD Anderson Cancer Center

Madrid, Spain, 28033

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Medizinische Hochsschule Hannover

Hannover, Germany

Northwestern University

Chicago, Illinois, United States, 60611

Oklahoma University Health – Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73117

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14203

The Mount Sinai Hospital

New York, New York, United States, 10029

UCLA Bowyer Oncology Center

Los Angeles, California, United States, 90095

Universitat de Barcelona

Barcelona, Spain 08035

University Medicine Greifswald

Greifswald, Germany, 17475

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

University of Michigan Hospitals

Ann Arbor, Michigan, United States, 48109

University of Southern California

Los Angeles, California, United States, 90033

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Weill Cornell Medical College – NY Presbyterian Hospital

New York, New York, United States, 10021

For more information, please email: KO-MEN-001@kuraoncology.com.
To connect with a medical science liaison (MSL), please email: medicalaffairs@kuraoncology.com.

REFERENCES

  • 1.Kühn MW, Song E, Feng Z et al. Targeting chromatin regulators inhibits leukemogenic gene expression in NPM1 mutant leukemia. Cancer Discov. 2016;6(10):1166-1181. 2. Klossowski S, Miao H, Kempinska K, et al. Menin inhibitor MI-3454 induces remission in MLL1-rearranged and NPM1-mutated models of leukemia. J Clin Invest. 2020;130(2):981-997. 3. Chan AKN, Chen CW. Rewiring the epigenetic networks in MLL-rearranged leukemias: epigenetic dysregulation and pharmacological interventions. Front Cell Dev Biol. 2019;7:81. 4. Burrows F, Wu T, Kessler L, et al. A novel small molecule menin-MLL inhibitor for potential treatment of MLL-rearranged leukemias and NPM1/DNMT3A-mutant AML [abstract]. In: Proceedings of the AACR EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2017 Oct 26-30; Philadelphia, PA. Philadelphia (PA): AACR; Mol Cancer Ther. 2018;17(1 Suppl): Abstract nr LB-A27. 5. Thiede C, Koch S, Creutzig E, et al. Prevalence and prognostic impact of NPM1 mutations in 1485 adult patients with acute myeloid leukemia (AML). Blood. 2006;107(10):4011-4020. 6. Prata PH, Bally C, Prebet T, et al. NPM1 mutation is not associated with prolonged complete remission in acute myeloid leukemia patients treated with hypomethylating agents. Haematologica. 2018;103(10):e455-e457.

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