MEI Pharma Presents Clinical Data from Ongoing Phase 1b Study of ME-401 in Patients with Indolent B-Cell Malignancies at the 2018 American Society of Hematology Annual Meeting
The data announced today continue to support the rationale for MEI's planned Phase 2 study that evaluates both a continuous (CS) and intermittent (IS) 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 (dosed on the CS or
- As a single agent, 76% objective response rate in patients with relapsed or refractory follicular lymphoma (FL), and 100% in all patients with chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL).
- 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 toIS . - 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 (CS) recaptured a response after progressing on
IS .
The ME-401 ASH 2018 poster can be accessed on the
"The data presented today are very supportive of our rationale to investigate both a continuous and intermittent dosing regimen as part of our Phase 2 study evaluating ME-401 in follicular lymphoma and may also help advance its complementary potential to deliver improved benefits to patients in combination with other modalities," said Daniel
ME-401 Phase 1b ASH 2018 Data
ME-401 is being evaluated in an ongoing Phase 1b dose escalation study in patients with relapsed or refractory B-cell malignancies. Through
- Group 1 included 31 patients with relapsed FL (n = 22) or CLL/SLL (n = 9) who received ME-401 CS at doses ≥60 mg per day in the dose escalation phase of the study. Beginning in
December 2017 a total of 17 patients from Group 1 (FL=9, CLL/SLL=8) advanced to theIS after in cycle 4 or later cycles. - Group 2 included 16 patients with relapsed FL (n = 9), diffuse large B-cell lymphoma (n = 5), marginal zone lymphoma (MZL, n = 1), and CLL (n = 1) who received rituximab 375 mg/m2 x 8 doses over 6 months and ME-401 dosed under the
IS regimen after receiving ME-401 60 mg daily for the first two cycles. - Group 3 may enroll up to 30 patients with relapsed FL/CLL/SLL in an expansion cohort of ME-401 using the
IS regimen after receiving ME-401 60 mg daily for the first two cycles. In this group, 13 patients were enrolled to date with one FL patient reaching the Cycle 6 disease assessment as data cut off.
The median number of prior therapies of patients in the study is two and 50% of patients enrolled were ≥ 3rd line of therapy. Responses are assessed after 2 cycles (58 days) and 6 cycles, and then every 6 cycles. Ninety-two percent of all patients were previously treated with an anti-CD20 antibody.
Objective Response Rates
- The objective response rate of patients across all groups with FL is 76% (29/38) and for CLL/SLL is 100% (11/11).
- As a single agent, 76% (22/29) objective response rate in patients with FL and 100% (10/10) in patients with CLL and SLL.
- In combination with rituximab, 78% (7/9) objective response rate in patients with FL.
Duration of Response
- In FL and CLL/SLL patients, the median follow-up is 9.3 months (range, approximately 2.1 to 19.5 months) with no median yet reached.
- Across all groups, failure-free survival (i.e. no disease progression on the continuous dosing schedule) in FL and CLL/SLL has not reached a median yet; median follow-up is 6.9 months (range 0.4 to 21.1 months).
- 72% of patients across all groups on the
IS regimen have not experienced disease progression with a median follow-up of 7.9 months (range, 0.8 to 10.5 months). - Of the 10 patients that progressed on the
IS regimen, 70% of patients retreated with daily dosing recaptured disease response.
Rates of irAEs
- Of the 36 patients who switched to
IS , only 11% (4/36) experienced an irAE after the switch. All 4 reported cases of irAEs occurred in the first 2 cycles after the switch to theIS regimen.
About ME-401
ME-401 is an investigational oral phosphatidylinositol 3-kinase ("PI3K") delta inhibitor; PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancer cells. ME-401 displays high selectivity for the PI3K delta isoform and has distinct pharmaceutical properties from other PI3K delta inhibitors. It is being clinically evaluated in patients with various B-cell malignancies. MEI is initiating a 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 is intended to support an accelerated approval marketing application with the
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