Sierra Oncology announces momelotinib achieved statistically significant benefit on symptoms, anemia and splenic size in the pivotal MOMENTUM study for myelofibrosis.
The trial met all of its primary and key secondary endpoints.
Topline data announced based on 195 patients (MMB n = 130; DAN n = 65) include: i. Primary Endpoint of Total Symptom Score (TSS) of greater than 50%: 25% in the MMB arm vs. 9% in the control arm (p=0.0095). ii. Secondary Endpoint of Transfusion Independence (TI): 31% in the MMB arm vs. 20% in the control arm (one-sided p=0.0064; non-inferiority). iii. Secondary Endpoint of Splenic Response Rate (SRR) greater than 35%: 23% in the MMB arm vs. 3% in the control arm (p=0.0006) iv. 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.
Mean baseline characteristics for all patients were TSS of 27, Hemoglobin (Hgb) of 8 g/dL and platelet count of 145 x 10 9/L.The full data set will be presented at an upcoming medical meeting.,
“As a clinician, I am thrilled to see data that confirm the potential of momelotinib as a treatment option for myelofibrosis patients who are anemic or at risk of becoming anemic,” said Ruben Mesa, MD, FACP, Executive Director of the Mays Cancer Center, home to UT Health San Antonio, MD Anderson Cancer Center, and co-Principal Investigator of the study. “Anemia of myelofibrosis is strongly correlated with reduced quality of life and a decrease in overall survival. Half of all myelofibrosis patients present with anemia at diagnosis and virtually all become anemic over time. With currently approved therapies being myelosuppressive, it’s wonderful to know that we may soon have such an effective treatment option for these patients.”
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