Phase III MOMENTUM study of CYT 387 in myelofibrosis presented at 2022 Annual Meeting of the European Hematology Association.
Sierra Oncology announced an abstract presenting the full data from the pivotal phase III MOMENTUM study of CYT 387 (momelotinib) in myelofibrosis patients who are symptomatic and anemic has been accepted into the program for the 2022 Annual Meeting of the European Hematology Association (EHA).
Additionally, a subset analysis from the trial evaluating safety and efficacy for patients with low platelet counts has been selected for poster presentation. Abstract: S195: MOMENTUM: Phase III Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor.
The primary and all key secondary results, as well as safety data, from the MOMENTUM pivotal Phase III trial of momelotinib will be presented in an oral presentation by Srdan Verstovsek, MD, PhD, co-Principal Investigator of the study. Topline results from the study were announced in January 2022.
Key data to be presented include: Primary Endpoint of Total Symptom Score (TSS) of >50%: 25% in the MMB arm vs. 9% in the control arm (p=0.0095). Secondary Endpoint of Transfusion Independence (TI): 31% in the MMB arm vs. 20% in the control arm (one-sided p=0.0064; non-inferiority). Secondary Endpoint of Splenic Response Rate (SRR) >35%: 23% in the MMB arm vs. 3% in the control arm (p=0.0006). The rate of Grade 3 or worse adverse events in the randomized treatment period was 54% in the MMB arm and 65% in the control arm. Serious treatment emergent adverse events were 35% in the MMB arm and 40% in the control arm.
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