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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

PR NewswireJune 3, 2019
-- 80% overall response rate in patients with relapsed or refractory follicular lymphoma --
-- Intermittent dosing schedule demonstrates comparable overall response rates with lower rate of delayed Grade 3 adverse events compared to continuous dosing schedule --
SAN DIEGO, June 3, 2019 /PRNewswire/ -- MEI Pharma, Inc. (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 1b study 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.
Andrew D. Zelenetz, M.D., Ph.D., Principal Investigator of the Phase 1b study and Professor of Medicine at Weill Cornell Medical College, Medical Director of Quality Informatics at Memorial Sloan Kettering Cancer Center, and Chair of the National Comprehensive Cancer Network's Non-Hodgkin Lymphoma Guideline Panel, commented: "ME-401 is a second generation PI3K inhibitor specific for the delta isoform that has excellent activity in CLL and FL. This class of drugs has been associated with immune related toxicities which are also seen with ME-401 dosed continuously. However, we explored a novel dosing strategy with intermittent drug exposure (one week on, 3 weeks off) that appears to markedly reduce toxicity and maintain efficacy. If validated, this could expand the role of PI3K in B-cell malignancies. A prospective randomized phase 2 trial is underway comparing intermittent to continuous dosing aiming to confirm these preliminary findings."
"The Phase 1b data remain very encouraging and support the further investigation of ME-401 for patients with relapsed or refractory follicular lymphoma," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "ME-401 further represents a unique opportunity to more broadly leverage the utility of PI3K as a central component of B-cell signaling and potentially offer a treatment option across multiple B-cell malignancies either as a monotherapy or in combination with other therapies."
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.
ME-401 Phase 1b Clinical Study
The ongoing Phase 1b clinical study is evaluating ME-401 as a monotherapy and in combination with rituximab or with zanubrutinib in patients with r/r B-cell malignancies. Over 85 patients have been enrolled to date, including 54 patients with r/r FL reported on in the ASCO 2019 poster. Sixty-five percent (35/54) of r/r FL patients had 2 or more prior lines of therapy. Of the 50 evaluable r/r FL patients, 52% (26/50) were a group of FL patients with progression of disease within 24 months (POD24) of initial immunochemotherapy, which typically have a poor prognosis compared to other r/r FL patients.
ME-401 was administered once daily at 60 mg for 2 28-day cycles and then on an intermittent schedule of once daily dosing for the first 7 days of each subsequent 28-day cycle (i.e. the intermittent schedule or IS). A previous cohort of monotherapy patients in the study was treated with ME-401 administered continuously once daily or were switched to the intermittent schedule in later cycles.
The overall response rate in patients with r/r FL was 80% (40/50), with 20% (10/50) achieving a complete response. Patients receiving monotherapy achieved a 79% (30/38) overall response rate and patients receiving ME-401 in combination with rituximab achieved an 83% (10/12) overall response rate. The group of patients receiving IS dosing achieved a 75% (15/20) overall response rate and patients receiving the CS dosing achieved an 83% (25/30) overall response rate. The response rate among POD24 patients was 92% (24/26).