Momelotinib improves outcomes in pretreated myelofibrosis
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A randomized phase 3 trial of momelotinib for patients with pretreated myelofibrosis met all primary and key secondary endpoints, according to topline data released by the agent’s manufacturer.
Momelotinib (Sierra Oncology) conferred statistically significant benefits in total symptom score, anemia and splenic response compared with danazol for patients previously treated with an approved Janus kinase (JAK) inhibitor, results of the double-blind MOMENTUM study showed.
“These data are extremely exciting and everything we had hoped to see from the trial,” Stephen Dilly, MBBS, PhD, president and CEO of Sierra Oncology, said in a company-issued press release. “To achieve statistically significant and clinically important efficacy across all prespecified primary and key secondary endpoints while maintaining platelet counts in such a difficult-to-treat patient population is remarkable — and a confirmation of the anemia response we identified in the comprehensive review of our previous phase 3 studies.”
Momelotinib is a selective, orally bioavailable JAK1, JAK2 and ACVR1/ALK2 inhibitor.
The topline announcement included data on 195 patients randomly assigned to momelotinib (n = 130) or danazol (n = 65). Mean baseline characteristics for the study cohort included total symptom score of 27, hemoglobin of 8 g/dL and platelet count of 145 x 109/L.
Total symptom score reduction of at least 50% served as the primary endpoint. A higher percentage of momelotinib-treated patients achieved this outcome (25% vs. 9%; P = .0095).
A higher percentage of momelotinib-treated patients achieved transfusion independence (31% vs. 20%; P = .0064) and splenic response rate of at least 35% (23% vs. 3%; P = .0006).
Researchers reported numerically lower rates of grade 3 or higher adverse events (54% vs. 65%) and serious treatment-emergent adverse events (35% vs. 40%) in the momelotinib group.
Complete data from the MOMENTUM study will be submitted for presentation at a medical meeting.
“As a clinician, I am thrilled to see data that confirm the potential of momelotinib as a treatment option for [patients with myelofibrosis] who are anemic or at risk of becoming anemic,” investigator Ruben A. Mesa, MD, FACP, executive director of Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center and a HemOnc Today Editorial Board member, said in the release. “Anemia of myelofibrosis is strongly correlated with reduced quality of life and a decrease in overall survival. Half of all [patients with myelofibrosis] 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.”
Sierra Oncology officials intend to submit a new drug application to the FDA based on the MOMENTUM study results in the second quarter of this year.
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