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Aaron Gerds, MD, assistant professor of medicine, Department of Hematology and Medical Oncology, deputy director, Clinical Research, Cleveland Clinic Taussig Cancer Institute, discusses data from the phase 3 SIMPLIFY-1 (NCT01969838) and MOMENTUM (NCT04173494) trials, which supported the FDA approval of momelotinib (Ojjaara ) for patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, and anemia. SIMPLIFY-1 was a prospective, randomized trial comparing momelotinib vs ruxolitinib (Jakafi) as frontline therapy forpatients with myelofibrosis who had not previously been treated with a JAK inhibitor, Gerds begins. In the study,treatment with momelotinib led to a noninferior reduction in spleen volume compared with ruxolitinib, he reports.
However, momelotinib was somewhat less effective than ruxolitinib in alleviating symptom burden. Although this method for measuring symptom burden has limitations, the finding raised questions about momelotinib’s role in symptom management, Gerds explains. Additionally, data from SIMPLIFY-1 suggested that momelotinib may provide benefit in terms of anemia management, Gerds continues.
Patients treated with momelotinib experienced less anemia compared with those on ruxolitinib. This was an early indication that momelotinib might serve as a dual-purpose therapy, addressing anemia and targeting spleen size and symptoms, he emphasizes. Building on these findings, the MOMENTUM trial was conducted to evaluate momelotinib in patients with anemia who had prior exposure to a JAK inhibitor and continued to experience splenomegaly and symptom burden, Gerds expands.
In this trial, momelotinib was compared with danazol, an established agent for managing anemia in myelofibrosis, he adds. Momelotinib outperformed danazol regarding spleen volume reduction and symptom burden improvement. Additionally, momelotinib demonstrated a noninferior improvement in anemia, reinforcing its unique ability to target all 3 critical aspects of myelofibrosis management.
This positions momelotinib as a versatile treatment option for patients with complex needs, Gerds concludes..
