Dr Gangat on Efficacy Data for Selcodebart in Myelofibrosis-Associated Anemia

“The drug does not have a direct impact on spleen improvement, but it enables optimization of JAK inhibitor therapy, which can sometimes be limited because of treatment-related anemia.”

Naseema Gangat, MBBS, a professor of medicine and a consultant in hematology at Mayo Clinic, discussed efficacy and safety data from the phase 2 RALLY-MF trial (NCT05320198) presented at the 2026 SOHO Annual Meeting.

RALLY-MF is evaluating the anti-hemojuvelin monoclonal antibody selcodebartin patients with myelofibrosis-associated anemia; data reported at SOHO 2026 included responses across 3 patient cohorts regardless of concomitant JAK inhibitor use. Efficacy was reported by cohort based on degree of anemia, Gangat said. In the non–transfusion-dependent cohort (n = 31), the major anemia response rate, defined as a minimum 1.5 g/dL hemoglobin level increase from baseline, was 55%, she added. In the low transfusion burden cohort (n = 11), the major response rate was 64%, corresponding to transfusion independence for at least 16 weeks with a minimum hemoglobin level of 7 g/dL, Gangat noted. In the high transfusion burden cohort, the major response rate was 50% with transfusion independence for at least 12 weeks at the same hemoglobin threshold, she explained. These results held regardless of concomitant JAK inhibitor therapy, according to Gangat; 52.5% of patients were receiving a JAK inhibitor, primarily ruxolitinib (Jakafi) or momelotinib (Ojjaara).

The responses translated into meaningful improvement in patient outcomes, Gangat explained, noting gains in FACIT-Fatigue and MPN Symptom Assessment Form scores that correlated with anemia improvement.

Turning to safety, Gangat said that selcodebart was extremely well tolerated, with treatment-related adverse effects (TRAEs) occurring in 24.6% of patients, all grade 1. Muscle spasms and diarrhea stood out as the notable TRAEs, Gangat pointed out.

Gangat noted that selcodebartdoes not directly reduce spleen volume but may enable optimization of JAK inhibitor dosing, with ruxolitinib, for example, particularly for patients beyond 6 months into the continuation phase of treatment. As for symptoms, she said the agent chiefly improves anemia-related fatigue rather than the broader inflammatory or constitutional symptoms associated with myelofibrosis, such as night sweats and weight loss. However, by easing anemia-related dose constraints, selcodebartmay still help patients derive optimal benefit from JAK inhibitor therapy for those symptoms, Gangat concluded.