MEI Updates on Monotherapy, Combo Follicular Lymphoma Phase 1b at ASCO

MEI Pharma, Inc.,  (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announced that updated data presented at ASCO 2019 from a Phase 1bstudy of investigational ME-401, a selective oral inhibitor of PI3K delta, demonstrate an 80% overall response rate in patients with relapsed or refractory (r/r) follicular lymphoma (FL) (n= 50). Additionally, the data demonstrate:

• Comparable overall response rates, ranging from 75% to 83%, across patient groups receiving ME-401 as a monotherapy or in combination with rituximab, and in patient groups dosed with ME-401 once daily on a continuous schedule (CS) or on an intermittent schedule (IS) of once daily for the first 7 days of a 28-day cycle after 2 months of continuous dosing.
• A lower rate of delayed, grade 3 adverse events (e.g. 8.7% diarrhea/colitis for IS dosing) observed in patients in the IS group.
• Durable responses in both CS and IS groups with no median yet reached.

The ME-401 ASCO 2019 poster can be accessed on the MEI Pharma website.

MEI has initiated a global Phase 2 study to evaluate the efficacy, safety, and tolerability of ME-401 as a single agent in patients with follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. The Phase 2 study, now labeled the TIDAL study ‘(Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), is intended to support an accelerated approval marketing application with the U.S. Food and Drug Administration.

https://www.biospace.com/article/releases/mei-pharma-presents-updated-clinical-data-from-the-me-401-monotherapy-and-in-combination-with-rituximab-phase-1b-study-in-patients-with-follicular-lymphoma-at-the-2019-american-society-of-clinical-oncology-asco-annual-meeting/