Dr Palandri on Outcomes With Momelotinib in Myelofibrosis Per Dual SVR35 and Transfusion Independence

"We observed that the dual response was significantly higher for the patients treated with momelotinib vs ruxolitinib. This is important because…we saw that for patients achieving a transfusion independence response with or without a spleen response, their prognosis was much better."

Francesca Palandri, MD, adjunct professor in the Department of Medical and Surgical Sciences at the University of Bologna, discussed findings from a subgroup analysis of the phase 3 SIMPLIFY-I trial (NCT01969838), which assessed how dual spleen response and transfusion independence (TI) correlate with improved prognosis after treatment with momelotinib (Ojjaara) in JAK inhibitor–naive patients with myelofibrosis and anemia.

The post hoc analysis focused on the subset of JAK inhibitor–naive patients with baseline hemoglobin less than 10 g/dL, reflecting the real-world population for whom momelotinib would be most relevant, Palandri began.

SIMPLIFY-I was a randomized trial comparing momelotinib (n = 215) vs ruxolitinib (n = 217) in patients with intermediate- or high-risk myelofibrosis. This analysis evaluated spleen volume reduction of at least 35% (SVR35), TI, and dual response (SVR35+TI) at week 24 across subgroups stratified by key baseline features, including platelet count.

Palandri noted that patients treated with momelotinib were more likely to achieve a dual response compared with those receiving ruxolitinib, particularly in patients with baseline platelet counts of less than 200 x 10⁹/L. Importantly, the dual response benefit with momelotinib was also observed in patients with platelet counts of 200 x 10⁹/L or higher, she noted. In these cases, although ruxolitinib maintained spleen response activity, it was associated with greater hematologic toxicity and a higher need for transfusions, resulting in lower dual response rates overall, Palandri explained.

The clinical significance of this dual response was underscored by subsequent analyses correlating response status with survival outcomes, Palandri continued. Patients who achieved transfusion independence—whether or not they also achieved a spleen response—demonstrated improved overall survival compared with those who did not. These findings support the prognostic value of early treatment response at 24 weeks, particularly regarding anemia control, she reiterated.

According to Palandri, these data reinforce the importance of targeting both spleen burden and transfusion dependency in the management of myelofibrosis. Momelotinib's ability to deliver dual clinical benefits may translate to improved long-term outcomes in patients with baseline anemia, making it a relevant therapeutic option for this population, she concluded.