PI3Kδ Inhibitor ME-401 Is Qualified By The US FDA Fast Track, And The Total Remission Rate For The Treatment Of 3 Types Of Tumors Is 75-100%

- May 13, 2020-

MEI Pharma is a late-stage clinical biopharmaceutical company dedicated to developing innovative therapies for cancer treatment. Recently, the company announced that the US Food and Drug Administration (FDA) has granted its oral selective phosphatidylinositol-3-kinase δ (PI3Kδ) inhibitor ME-401 fast-track qualification (FTD) for the treatment of accepted Adult patients with relapsed or refractory follicular lymphoma (R / R FL) of at least 2 systemic therapies.

ME-401 is a study of oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor. PI3Kδ inhibitors are usually overexpressed in cancer cells and play a key role in the proliferation and survival of blood tumors. ME-401 shows high selectivity for PI3Kδ subtypes, and has different drug properties from other PI3Kδ inhibitors. The drug has the potential to become a best-in-class PI3Kδ inhibitor. Its clinical characteristics indicate that as a monotherapy or in combination with other cancer drugs, it has the opportunity to solve a series of B-cell malignancies. Currently, MEI is evaluating ME-401 to treat patients with various B-cell malignancies.

The Fast Track Qualification (FTD) is designed to accelerate the development and rapid review of drugs for serious diseases to address serious unmet medical needs in key areas. Obtaining fast-track qualifications for experimental drugs means that pharmaceutical companies can interact with the FDA more frequently during the R & D phase. After submitting marketing applications, they are eligible for accelerated approval and priority review if they meet the relevant standards. In addition, they are eligible for rolling review.

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Currently, MEI is conducting a global phase II TIDAL clinical trial to evaluate ME-401 as a monotherapy for R / R FL adults who have failed at least 2 systemic therapies (including chemotherapy and anti-CD20 antibodies) patient. The results of the trial will be used to support the application for accelerated approval of ME-401 to the US FDA.

In addition to the TIDAL trial, MEI is also conducting a multi-arm, open-label, phase Ib dose escalation and expansion trial to evaluate ME-401 as a monotherapy, in combination with other therapies (such as rituximab) or drugs ( Such as Brukinsa [zanubrutinib, zebinib], Baekje China BTK inhibitor) combined treatment for relapsed or refractory B-cell malignancies, including follicular lymphoma (FL), chronic lymphocytic leukemia / small cell lymphoma Tumor (CLL / SLL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL).

In October last year, MEI announced the updated data of the Phase Ib study. The results show that the total remission rate (ORR) of all patient groups (FLL + CLL / SLL) treated with ME-401 is 75-100%, specifically: (1) the ORR of all FL patients is 78% (n = 43/55), the ORR of the ME-401 monotherapy group was 79%, and the ORR of the ME-401 + rituximab combination therapy group was 75%. (2) The ORR was 89% (n = 16/18) in all CLL / SLL patients, the ORR was 100% in the ME-401 monotherapy group, and the ORR was 71% in the ME-401 + rituximab combination therapy group.


In this study, the ME-401 continuous dosing regimen (CS) and intermittent dosing regimen (IS) showed high remission rates and long-lasting remission in both FL and CLL / SLL patients, but the ME-401 observed in the IS regimen group The incidence of treatment-related grade 3 adverse events was lower than in the CS regimen group. For example, the incidence of grade 3 diarrhea / colitis is 5% in the IS regimen group and 23% in the CS regimen group.

In November 2018, BeiGene and MEI Pharmaceuticals reached a non-exclusive clinical cooperation to evaluate the potential of ME-401 and Brukinsa to treat B-cell malignancies. At present, the ME-401 + Brukinsa combination treatment plan has been included in the above multi-arm, open-label Phase Ib study to evaluate the potential for treatment of FL, MCL, and DLBCL.

Brukinsa (Zebutinib, zanubrutinib) is a BTK inhibitor from BeiGene. It was approved by the US FDA in November 2019 for the treatment of adult mantle cell lymphoma (MCL) with at least one previous therapy. patient. It is particularly worth mentioning that Brukinsa is the first product independently approved by Baekje China to be listed on the market, marking a major milestone in the company ’s development process, and also marking the first model developed entirely by Chinese companies. The new anti-cancer drug approved by the US FDA has achieved a "zero breakthrough" for the Chinese original researched new drug.