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Journal Articles

Trial Update from IMproveMF, an Ongoing, Open-Label, Dose-Escalation and -Expansion, Phase 1/1B Trial to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of the Novel Combination of Imetelstat with Ruxolitinib in Patients with Intermediate-1, Intermediate-2, or High-Risk Myelofibrosis (MF)

John O. Mascarenhas, Salman Otoukesh, Terrence Bradley, Bart L. Scott, Habte A. Yimer, Souria Dougherty, Lixian Peng, Fei Huang, Ying Wan, Faye M. Feller, Vivian Rodolf, Judy Ho, Tymara Berry, Andrew T. Kuykendall

Blood (2024) 144 (Supplement 1): 998.

https://doi.org/10.1182/blood-2024-203800

Published: 2024

Journal Articles

Initial Results from the QTc Substudy of the IMerge Phase 3 Trial Demonstrate Clinically Meaningful Efficacy, Manageable Safety, and Absence of Proarrhythmic Risk in Patients with Lower-Risk Myelodysplastic Syndromes Who Received Prior Therapies Beyond Erythropoiesis Stimulating Agents

Blood (2024) 144 (Supplement 1): 4590.

https://doi.org/10.1182/blood-2024-200885

Published: 2024

Journal Articles

Imetelstat Versus Best Available Therapy in Patients with Intermediate-2 or High-Risk Myelofibrosis Relapsed or Refractory to Janus Kinase Inhibitor in IMpactMF, a Randomized, Open-Label, Phase 3 Trial

John O. Mascarenhas, Claire Harrison, Prithviraj Bose, Jean-Jacques Kiladjian, Alessandro Lucchesi, Alessandro Maria Vannucchi, Tymara Berry, Jennifer Riggs, Lixian Peng, Fei Huang, Ying Wan, Vivian Rodolf, Judy Ho, Shyamala Navada, Rami S. Komrokji

Blood (2024) 144 (Supplement 1): 1808.1.

https://doi.org/10.1182/blood-2024-199235

Published: 2024

Journal Articles

Durable Continuous Transfusion Independence (TI) with Imetelstat in IMerge Phase 3 for Patients with Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to or Ineligible for Erythropoiesis-Stimulating Agents (ESAs)

Uwe Platzbecker, Rami S. Komrokji, Amer M. Zeidan, Pierre Fenaux, Mikkael A. Sekeres, Michael R. Savona, Yazan F. Madanat, Anna Jonášová, Thomas Illmer, Laurie Sherman, Tymara Berry, Jennifer Riggs, Qi Xia, Shyamala Navada, Ying Wan, Fei Huang, Faye M. Feller, Valeria Santini

Blood (2023) 142 (Supplement 1): 4605.

https://doi.org/10.1182/blood-2023-181154

Published: 2023

Journal Articles

Improvement of Patient-Reported Outcomes Among Heavily Pretreated Patients with Lower-Risk Myelodysplastic Syndromes and High Transfusion Burden Treated with Imetelstat on the IMerge Phase 3 Trial

Mikkael A. Sekeres, Maria Diez-Campelo, Amer M. Zeidan, Uwe Platzbecker, Antoine Regnault, Kristin Creel, Nishan Sengupta, Ying Wan, Libo Sun, Qi Xia, Tymara Berry, Souria Dougherty, Sheetal Shah, Shyamala Navada, Valeria Santini, David Valcárcel

Blood (2023) 142 (Supplement 1): 6479.

https://doi.org/10.1182/blood-2023-181103

Published: 2023

Journal Articles

Efficacy of Imetelstat in Achieving Red Blood Cell Transfusion Independence (RBC-TI) across Different Risk Subgroups in Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis-Stimulating Agents (ESAs) in IMerge Phase 3 Study

Rami S. Komrokji, Valeria Santini, Pierre Fenaux, Michael R. Savona, Yazan F. Madanat, Tymara Berry, Laurie Sherman, Shyamala Navada, Faye M. Feller, Libo Sun, Qi Xia, Ying Wan, Fei Huang, Amer M. Zeidan, Uwe Platzbecker

Blood (2023) 142 (Supplement 1): 194.

https://doi.org/10.1182/blood-2023-181237

Published: 2023

Journal Articles

Impact of Mutational Status on Clinical Response to Imetelstat in Patients with Lower-Risk Myelodysplastic Syndromes in the IMerge Phase 3 Study

Valeria Santini, Amer M. Zeidan, Pierre Fenaux, Yazan F. Madanat, Tymara Berry, Faye M. Feller, Libo Sun, Qi Xia, Ying Wan, Fei Huang, Michael R. Savona, Uwe Platzbecker

Blood (2023) 142 (Supplement 1): 4603.

https://doi.org/10.1182/blood-2023-179378

Published: 2023

Journal Articles

Characterization and Management of Cytopenias after Imetelstat Treatment in the IMerge Phase 3 Trial of Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Amer M. Zeidan, Michael R. Savona, Yazan F. Madanat, Pierre Fenaux, Rami S. Komrokji, Anna Jonášová, Thomas Illmer, Libo Sun, Tymara Berry, Faye M. Feller, Shyamala Navada, Valeria Santini, Uwe Platzbecker

Blood (2023) 142 (Supplement 1): 6478.

https://doi.org/10.1182/blood-2023-180962

Published: 2023

Journal Articles

Imetelstat Achieved Prolonged, Continuous Transfusion Independence (TI) in Patients with Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Syndrome (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs) within the IMerge Phase 2 Study

Blood (2022) 140 (Supplement 1): 1106–1108.

https://doi.org/10.1182/blood-2022-169050

Published: 2022

Journal Articles

MYF1001: An Open Label, Dose Escalation and Expansion, Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination with Ruxolitinib in Patients with Intermediate 1, Intermediate 2 or High-Risk Myelofibrosis

Terrence Bradley, Andrew Kuykendall, Rami S. Komrokji, Tymara Berry, Souria Dougherty, Laurie Sherman, Lixian Peng, Fei Huang, Ying Wan, Faye Feller, John Mascarenhas

Blood (2022) 140 (Supplement 1): 3941–3942.

https://doi.org/10.1182/blood-2022-159614

Published: 2022

Journal Articles

MYF3001: A Randomized Open Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy in Patients with Intermediate-2 or High-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitor

John Mascarenhas, Claire Harrison, Jean-Jacques Kiladjian, Rami S. Komrokji, Steffen Koschmieder, Alessandro M. Vannucchi, Tymara Berry, Denise Redding, Laurie Sherman, Souria Dougherty, Lixian Peng, Libo Sun, Fei Huang, Ying Wan, Faye Feller, Srdan Verstovsek

Blood (2022) 140 (Supplement 1): 6826–6829.

https://doi.org/10.1182/blood-2022-160364

Published: 2022

Journal Articles

On-Target Activity of Imetelstat Correlates with Clinical Benefits, Including Overall Survival (OS), in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)

Blood (2021) 138 (Supplement 1): 2598.

https://doi.org/10.1182/blood-2021-148876

Published: 2021

Journal Articles

A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients with Intermediate-2 (Int-2) or High-Risk Myelofibrosis (MF) Refractory to Janus Kinase Inhibitor (JAKi)

John Mascarenhas, Claire N. Harrison, Jean-Jacques Kiladjian, Rami S. Komrokji, Steffen Koschmieder, Alessandro Vannucchi, Tymara Berry, Laurie Sherman, Souria Dougherty, Libo Sun, Fei Huang, Ying Wan, Faye Feller, Aleksandra Rizo, Srdan Verstovsek

Blood (2021) 138 (Supplement 1): 1503.

https://doi.org/10.1182/blood-2021-148931

Published: 2021

Journal Articles

A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients with Intermediate-2 or High-Risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK) Inhibitor

John Mascarenhas, MD, Claire Harrison, DM, FRCP, FRCPath, Jean-Jacques Kiladjian, MD PhD, Ruben Mesa, MD, Rami S. Komrokji, MD, Steffen Koschmieder, MD, Alessandro M. Vannucchi, MD, Tymara Berry, MD, Laurie Sherman, BSN, Souria Dougherty, BS, MBA, Libo Sun, PhD, Fei Huang, PhD, Ying Wan, PhD, Faye Feller, MD, Aleksandra Rizo, MD PhD, Srdan Verstovsek, MD PhD

Blood (2020) 136 (Supplement 1): 43–44.

https://doi.org/10.1182/blood-2020-138915

Published: 2020

Journal Articles

Imerge: A Phase 3 Study to Evaluate Imetelstat in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) That Is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Blood (2020) 136 (Supplement 1): 17.

https://doi.org/10.1182/blood-2020-138810

Published: 2020

Journal Articles

Potential Disease-Modifying Activity of Imetelstat Demonstrated By Reduction in Cytogenetically Abnormal Clones and Mutation Burden Leads to Clinical Benefits in Relapsed/Refractory Myelofibrosis Patients

John Mascarenhas, MD, Rami S. Komrokji, MD, Michele Cavo, Bruno Martino, MD, Dietger Niederwieser, MD PhD, Andreas Reiter, MD, Bart L. Scott, MD, Maria R. Baer, MD, Ronald Hoffman, MD, Olatoyosi Odenike, MD, Laurie Sherman, BSN, Souria Dougherty, BS, MBA, Faye Feller, MD, Tymara Berry, MD, Libo Sun, PhD, Ying Wan, PhD, Aleksandra Rizo, MD PhD, Fei Huang, PhD, Jean-Jacques Kiladjian, MD PhD

Blood (2020) 136 (Supplement 1): 39–40.

https://doi.org/10.1182/blood-2020-138818

Published: 2020

Journal Articles

Correlation Analyses of Imetelstat Exposure with Pharmacodynamic Effect, Efficacy and Safety in a Phase 2 Study in Patients with Higher-Risk Myelofibrosis Refractory to Janus Kinase Inhibitor Identified an Optimal Dosing Regimen for Phase 3 Study

John Mascarenhas, MD, Rami S. Komrokji, MD, Michele Cavo, Bruno Martino, MD, Dietger Niederwieser, MD PhD, Andreas Reiter, MD, Bart L. Scott, MD, Maria R. Baer, MD, Ronald Hoffman, MD, Olatoyosi Odenike, MD, Laurie Sherman, BSN, Souria Dougherty, BS, MBA, Tymara Berry, MD, Faye Feller, MD, Libo Sun, PhD, Ying Wan, PhD, Aleksandra Rizo, MD PhD, Fei Huang, PhD, Jean-Jacques Kiladjian, MD PhD

Blood (2020) 136 (Supplement 1): 33–34.

https://doi.org/10.1182/blood-2020-138905

Published: 2020

Journal Articles

Fedratinib Induces Spleen Responses and Reduces Symptom Burden in Patients with Myeloproliferative Neoplasm (MPN)-Associated Myelofibrosis (MF) and Low Platelet Counts, who were Either Ruxolitinib-Naïve or were Previously Treated with Ruxolitinib

Claire N Harrison, Professor, Nicolaas Schaap, MD PhD, Alessandro M Vannucchi, MD, Jean-Jacques Kiladjian, MD PhD, Francesco Passamonti, MD, Sonja Zweegman, MD PhD, Moshe Talpaz, MD, Srdan Verstovsek, MD PhD, Shelonitda Rose, Jun Zhang, PhD, Tymara Berry, MD, Carrie Brownstein, MD, Ruben A Mesa, MD

Blood (2019) 134 (Supplement_1): 668.

https://doi.org/10.1182/blood-2019-129288

Published: 2019

Journal Articles

Fedratinib Induces Spleen Responses in Patients with Myeloproliferative Neoplasm-Associated Intermediate- or High-Risk Myelofibrosis (MF) Previously Exposed to Ruxolitinib (RUX), Regardless of Reason for Discontinuing RUX

Claire N Harrison, Professor, Nicolaas Schaap, MD PhD, Alessandro M Vannucchi, MD, Jean-Jacques Kiladjian, MD PhD, Eric Jourdan, MD, Richard T. Silver, MD, Harry C Schouten, MD PhD, Francesco Passamonti, MD, Sonja Zweegman, Moshe Talpaz, MD, Srdan Verstovsek, MD PhD, Shelonitda Rose, Juan Shen, PhD, Tymara Berry, MD, Carrie Brownstein, MD, Ruben A Mesa, MD

Blood (2019) 134 (Supplement_1): 4165.

https://doi.org/10.1182/blood-2019-130069

Published: 2019

NARROW

Initial Results from the QTc Substudy of the IMerge Phase 3 Trial Demonstrate Clinically Meaningful Efficacy, Manageable Safety, and Absence of Proarrhythmic Risk in Patients with Lower-Risk Myelodysplastic Syndromes Who Received Prior Therapies Beyond Erythropoiesis Stimulating Agents

Imetelstat Versus Best Available Therapy in Patients with Intermediate-2 or High-Risk Myelofibrosis Relapsed or Refractory to Janus Kinase Inhibitor in IMpactMF, a Randomized, Open-Label, Phase 3 Trial

Durable Continuous Transfusion Independence (TI) with Imetelstat in IMerge Phase 3 for Patients with Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to or Ineligible for Erythropoiesis-Stimulating Agents (ESAs)

Improvement of Patient-Reported Outcomes Among Heavily Pretreated Patients with Lower-Risk Myelodysplastic Syndromes and High Transfusion Burden Treated with Imetelstat on the IMerge Phase 3 Trial

Efficacy of Imetelstat in Achieving Red Blood Cell Transfusion Independence (RBC-TI) across Different Risk Subgroups in Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis-Stimulating Agents (ESAs) in IMerge Phase 3 Study

Impact of Mutational Status on Clinical Response to Imetelstat in Patients with Lower-Risk Myelodysplastic Syndromes in the IMerge Phase 3 Study

Characterization and Management of Cytopenias after Imetelstat Treatment in the IMerge Phase 3 Trial of Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Imetelstat Achieved Prolonged, Continuous Transfusion Independence (TI) in Patients with Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Syndrome (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs) within the IMerge Phase 2 Study

MYF1001: An Open Label, Dose Escalation and Expansion, Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination with Ruxolitinib in Patients with Intermediate 1, Intermediate 2 or High-Risk Myelofibrosis

MYF3001: A Randomized Open Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy in Patients with Intermediate-2 or High-Risk Myelofibrosis Relapsed/Refractory to Janus Kinase Inhibitor

On-Target Activity of Imetelstat Correlates with Clinical Benefits, Including Overall Survival (OS), in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)

A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients with Intermediate-2 (Int-2) or High-Risk Myelofibrosis (MF) Refractory to Janus Kinase Inhibitor (JAKi)

A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients with Intermediate-2 or High-Risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK) Inhibitor

Imerge: A Phase 3 Study to Evaluate Imetelstat in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) That Is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Potential Disease-Modifying Activity of Imetelstat Demonstrated By Reduction in Cytogenetically Abnormal Clones and Mutation Burden Leads to Clinical Benefits in Relapsed/Refractory Myelofibrosis Patients

Correlation Analyses of Imetelstat Exposure with Pharmacodynamic Effect, Efficacy and Safety in a Phase 2 Study in Patients with Higher-Risk Myelofibrosis Refractory to Janus Kinase Inhibitor Identified an Optimal Dosing Regimen for Phase 3 Study

Fedratinib Induces Spleen Responses and Reduces Symptom Burden in Patients with Myeloproliferative Neoplasm (MPN)-Associated Myelofibrosis (MF) and Low Platelet Counts, who were Either Ruxolitinib-Naïve or were Previously Treated with Ruxolitinib

Fedratinib Induces Spleen Responses in Patients with Myeloproliferative Neoplasm-Associated Intermediate- or High-Risk Myelofibrosis (MF) Previously Exposed to Ruxolitinib (RUX), Regardless of Reason for Discontinuing RUX

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American Society of Hematology

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