Srdan Verstovsek, MD, Ph.D., Professor, Department of Leukemia at MD Anderson Cancer Center. In this video, he speaks about Sierra Oncology Announces Momelotinib Achieved Statistically Significant Benefit on Symptoms, Anemia and Splenic Size in the Pivotal MOMENTUM Study for Myelofibrosis.
Sierra Oncology, Inc., a late-stage biopharmaceutical company focused on developing targeted therapies for rare cancers, today announced positive topline data from the pivotal Phase 3 MOMENTUM study, a global, randomized, double-blind clinical trial evaluating momelotinib (MMB) in myelofibrosis patients who are symptomatic and anemic and have previously received an approved JAK inhibitor. All of the trial 's primary and secondary endpoints were fulfilled.
* The following are the topline results based on 195 patients (MMB n = 130; DAN n = 65):
* TSS of >50% was the primary endpoint: 25% in the MMB arm vs. 9% in the control arm (p=0.0095).
* Transfusion Independence (TI) Secondary Endpoint: 31% in the MMB arm vs. 20% in the control arm (one-sided p=0.0064; non-inferiority)
* Splenic Response Rate (SRR) >35% as a secondary endpoint: 23% in the MMB arm vs. 3% in the control arm (p=0.0006).
* The rate of Grade 3 or worse adverse events was 54 percent in the MMB arm and 65 percent in the control arm during the randomized treatment period. The MMB arm had 35% serious treatment-emergent adverse events, while the control arm had 40%.
* All patients had a TSS of 27, a hemoglobin (Hgb) of 8 g/dL, and a platelet count of 145 x 10 9/L at baseline.
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