Post Hoc Data Show Anemia Benefits, Reduced Transfusion Burden With Momelotinib in Myelofibrosis

Author(s): Chris Ryan

Fact checked by: Ashling Wahner

A post hoc analysis of a single-arm, phase 2 study (NCT02515630) and the phase 3 SIMPLIFY-1 (NCT01969838), SIMPLIFY-2 (NCT02101268), and MOMENTUM (NCT04173494) studies showed that momelotinib (Ojjaara) was associated with anemia-related benefits in most patients and a reduction in transfusion burden vs comparator treatments in patients with JAK inhibitor–naive and –experienced myelofibrosis.1

Findings published in Clinical Lymphoma, Myeloma & Leukemia showed that more than 77% of patients treated with momelotinib across the 4 trials experienced a numerical reduction in red blood cell (RBC) transfusion requirements during treatment compared with baseline.

“This [post hoc analysis] demonstrates that across all 3 phase 3 trials of momelotinib in myelofibrosis to date, at least 75% of patients treated with momelotinib either maintained or experienced improved transfusion intensities vs baseline,” lead study author Claire Harrison, MD, FRCP, FRCPath, a professor of myeloproliferative neoplasm and clinical director of Guy’s and St Thomas’ NHS Foundation Trust in London, United Kingdom, and colleagues wrote in the publication. “These results provide evidence that underscores the consistent anemia benefits provided by momelotinib for the majority of patients.”

In September 2023, the FDA approved momelotinib for the treatment of adult patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, and anemia.2 This regulatory decision was supported by data from MOMENTUM and a subgroup of patients with anemia treated during SIMPLIFY-1.

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Optimizing Treatment in Patients With Myelofibrosis and Transfusion-Dependent Anemia

By Clinical Content Hub

In patients with MF, greater anemia severity and transfusion dependency have been linked to worse overall survival and quality of life (QOL). Historically, the only available treatment strategies for MF-related anemia have shown limited efficacy and an increased risk for numerous adverse effects.1,2

In September 2023, the US Food and Drug Administration (FDA) approved momelotinib, an oral inhibitor of JAK1 and JAK2 as well as activin A receptor type 1 (ACVR1), for the treatment of adults with anemia and intermediate or high-risk MF. Momelotinib is currently the only FDA-approved therapy indicated for the treatment of MF patients with anemia.3 In clinical trials, this first-in-class treatment has shown efficacy in treating anemia and other key manifestations of MF.4

Douglas Tremblay, MD, is an assistant professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, New York, specializing in hematologic malignancies such as myelodysplastic/myeloproliferative overlap syndromes, myeloproliferative neoplasms, and acute myeloid leukemia. He serves as the principal investigator on multiple clinical trials focused on myeloid neoplasms. In this article, Dr Tremblay discusses treatment strategies for MF patients, with a particular focus on those with transfusion-dependent anemia, as well as emerging developments in the MF treatment landscape.

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