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Gilead (GILD) Announces Top-Line Results From Two Phase 3 Studies Evaluating Momelotinib for Patients With Myelofibrosis

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Clinical Data The SIMPLIFY-1 study achieved its pre-specified primary endpoint of non-inferiority to ruxolitinib for splenic response rate at Week 24 (SRR24), defined as the percentage of patients experiencing a ≥ 35 percent reduction in spleen volume (momelotinib: 26.5%; ruxolitinib: 29.0%; 95 percent CI: -11.2% to +5.6%; p=0.011).Non-inferiority was not achieved for the key secondary endpoint of response rate in total symptom score (TSS). Greater improvements in all three pre-specified anemia-related secondary endpoints (proportion of patients who are transfusion independent, or transfusion dependent and transfusion rate) were observed in patients receiving momelotinib compared to ruxolitinib. However, because the TSS response rate did not meet the non-inferiority test, formal sequential statistical testing was not undertaken for these three additional anemia secondary endpoints.During 24 weeks of treatment in SIMPLIFY-1, the most frequent adverse events in patients receiving momelotinib were thrombocytopenia, diarrhea, headache, dizziness and nausea; the most frequent adverse events in patients receiving ruxolitinib were anemia, thrombocytopenia, diarrhea, headache and dizziness. Ten percent of patients receiving momelotinib reported peripheral neuropathy (any grade) compared to five percent of ruxolitinib-treated patients. There was no Grade ≥3 peripheral neuropathy in momelotinib-treated patients and one case in ruxolitinib-treated patients during 24 weeks of treatment.SIMPLIFY-2 did not achieve its primary endpoint of superiority of momelotinib compared to BAT in patients previously treated with ruxolitinib in SRR24 (momelotinib: 6.7%; BAT: 5.8%; 95 percent CI: -8.9% to +10.2%; p=0.90). Eighty-eight percent of patients randomized to the BAT arm continued to receive ruxolitinib; the remainder of patients received chemotherapy, interferon, corticosteroids, other therapies or some combination thereof. Differences in favor of momelotinib were observed for the pre-specified secondary endpoints of TSS and one of the three anemia-related endpoints (transfusion independence), however, formal sequential statistical testing was not undertaken because the primary superiority endpoint was not achieved.
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Nov 16, 2016
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Related Keywords Momelotinib, Myelofibrosis, Simplify-2, Simplify-1, Thrombocytopenia, Diarrhea, Headache, Dizzine, Momelotinib