Gilead Announces Top Line Results From Two Phase 3 Studies Evaluating Momelotinib for Patients With Myelofibrosis
The results from both the SIMPLIFY‑1 and SIMPLIFY‑2 studies indicate that momelotinib provides some treatment benefit, including benefit on anemia‑related endpoints.
Gilead Sciences announced top‑line results from two phase 3 trials (SIMPLIFY‑1 and SIMPLIFY‑2) evaluating the investigational JAK inhibitor momelotinib versus ruxolitinib or best‑alternative therapy in patients with myelofibrosis. In SIMPLIFY‑1, the primary endpoint of non‑inferiority versus ruxolitinib for splenic response at week 24 was met (26.5 % versus 29.0 %). SIMPLIFY‑2 did not meet its primary superiority endpoint versus best‑alternative therapy (6.7 % versus 5.8 %). Momelotinib showed additional benefits on anemia‑related endpoints compared with ruxolitinib, but official regulatory submission status remains pending.
For patients with myelofibrosis, the availability of a JAK inhibitor that can potentially improve splenic response and anemia without the need for prior ruxolitinib exposure may expand therapeutic options beyond current standard therapies.
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