MEI Pharma presents data from ongoing Phase 1b Lymphoma Study

MEI Pharma announced that results from an ongoing Phase 1b study support the complementary potential of intermittent and continuous dosing schedules of ME-401, a selective phosphatidylinositol 3-kinase delta inhibitor, to optimize the clinical risk-benefit ratio in patients with relapsed/refractory follicular lymphoma. The data demonstrate that ME-401, as both a single agent and in combination with rituximab, continues to be associated with overall high objective response rates. In addition, low rates of Grade 3 immune-related adverse events were observed in patients on the intermittent dosing schedule while maintaining a high level of clinical response. The data announced at ASH continues to support the rationale for MEI’s planned Phase 2 study that evaluates both a continuous and intermittent dosing schedule of ME-401 as a means to enhance the drug candidate’s clinical profile and thus potentially deliver improved benefits to patients. The Phase 2 study is expected to start around year-end and is intended to support MEI’s accelerated approval registration strategy if successful. Patients in the Phase 1b study received ME-401 as a single agent and in combination with rituximab to explore treatment options for patients with B-cell malignancies. The IS dosing regimen consists of 60 mg given continuously, once-daily, for the first 2 cycles followed by 60 mg given on days 1-7 of a 28-day cycle and results showed: As a single agent, 76% objective response rate in patients with relapsed or refractory follicular lymphoma, and 100% in all patients with chronic lymphocytic lymphoma and small lymphocytic lymphoma. In combination with rituximab, 78% objective response rate in patients with FL. Median duration of response has not been reached. The lead patient has a duration of response of approximately 20 months and the median follow-up is 9.3 months. Low rate of irAEs; 4 irAEs were reported in 36 patients administered the IS, with all cases occurring in the first 2 cycles following the switch to IS. 89% of patients switched to IS remain on therapy. Disease control was maintained in 72% of these patients. 70% of patients who resumed on the continuous daily dosing schedule recaptured a response after progressing on IS.
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