Rafe Donahue

Anemia-related response end points in myelofibrosis clinical trials: current trends and need for renewed consensus

Barbara Klencke, Rafe Donahue, Boris Gorsh, Catherine Ellis et autres

JAK inhibitors are the current standard of care in myelofibrosis, but many do not address and may worsen anemia; thus, anemia-related responses have traditionally been overlooked as efficacy end points in pivotal clinical trials, leading to a lack of consistency and analytic …

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Meaningful Symptomatic Change in Patients With Myelofibrosis From the SIMPLIFY Studies

Stacie Hudgens, Srđan Verstovšek, Lysbeth Floden, Claire Harrison et autres

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Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study

Ruben A. Mesa, Claire Harrison, Jeanne Palmer, Vikas Gupta et autres

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that typically manifests with debilitating symptoms that progressively worsen, negatively impacting patients' quality of life. Fatigue is a multifactorial and burdensome MF-related symptom due to its severity, persistence, and prevalence, with anemia a contributing factor …

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P1044: REDUCTION IN RED BLOOD CELL TRANSFUSION BURDEN: A NOVEL LONGITUDINAL TIME-DEPENDENT ANALYSIS IN PATIENTS WITH TRANSFUSION-DEPENDENT MYELOFIBROSIS TREATED WITH MOMELOTINIB

Claire Harrison, Ruben A. Mesa, Moshe Talpaz, Vikas Gupta et autres

Topic: 16. Myeloproliferative neoplasms - Clinical Background: In addition to splenomegaly and constitutional symptoms, anemia is a high medical need in patients with myelofibrosis (MF). Although anemia in patients with MF is commonly managed with red blood cell (RBC) transfusions, their use …

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Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study

Aaron T. Gerds, Srđan Verstovšek, Alessandro M. Vannucchi, Haifa Kathrin Al‐Ali et autres

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Symptomatic benefit of momelotinib in patients with myelofibrosis: Results from the SIMPLIFY phase III studies

Ruben A. Mesa, Stacie Hudgens, Lysbeth Floden, Claire Harrison et autres

BACKGROUND: Myelofibrosis (MF)-associated constitutional symptoms can severely impact health-related quality of life. Clinical trials in MF traditionally measure symptom response to treatment as a landmark endpoint of total symptom score (TSS) reduction ≥50% from baseline. However, this dichotomous assessment provides a limited …

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Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study

Srđan Verstovšek, Aaron T. Gerds, Alessandro M. Vannucchi, Haifa Kathrin Al‐Ali et autres

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The Impact of Momelotinib on Patient Reported Quality of Life for Symptomatic and Anemic Patients with Myelofibrosis: Results from the Phase 3 Momentum Study

Ruben A. Mesa, Claire Harrison, Jeanne Palmer, Vikas Gupta et autres

Introduction Disease-related inflammation, anemia and splenomegaly contribute to a host of burdensome symptoms in patients with myelofibrosis (MF), including fatigue, bone pain, night sweats, and others, which can negatively impact health-related quality of life (HRQoL). There are no approved treatments for patients …

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Updated Results from the Momentum Phase 3 Study of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor

Aaron T. Gerds, Ruben A. Mesa, Alessandro M. Vannucchi, Haifa Kathrin Al‐Ali et autres

Introduction: MMB, an oral JAK1, JAK2, and ACVR1 inhibitor, showed clinical activity on MF symptoms, red blood cell (RBC) transfusion requirements (anemia), and spleen volume in the prior phase 3 SIMPLIFY trials. The pivotal phase 3 MOMENTUM study (NCT04173494) of MF patients …

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Transfusion Independence Response As a Potential Surrogate for Overall Survival in Jaki-Experienced Patients with Myelofibrosis from Momentum

Srđan Verstovšek, Stephen T. Oh, Jean‐Jacques Kiladjian, Uwe Platzbecker et autres

Introduction: Momelotinib (MMB), an oral ACVR1, JAK1 and JAK2 inhibitor, has previously demonstrated clinical activity on symptoms, anemia and spleen volume in JAK inhibitor (JAKi)-naïve and JAKi -experienced patients with myelofibrosis (MF). A commonly used anemia endpoint, transfusion independence response (TI-R), is …

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MPN-478 MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor

Ruben A. Mesa, Aaron T. Gerds, Alessandro M. Vannucchi, Haifa Kathrin Al‐Ali et autres

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MPN-483 Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]

Aaron T. Gerds, Srđan Verstovšek, Alessandro M. Vannucchi, Haifa Kathrin Al‐Ali et autres

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