Benzinga | Oct 2, 2020 07:05AM EDT

MEI Pharma, Kyowa Kirin Report First Patient Dosed In Japanese Pivotal Phase 2 Study Of Zandelisib In Patients With Indolent B-Cell Non-Hodgkin's Lymphoma

Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, and MEI Pharma, Inc. (NASDAQ:MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announced the first patient has been dosed in the pivotal Phase 2 study of zandelisib (formerly called ME-401), an oral, once-daily, investigational drug-candidate selective for phosphatidylinositol 3-kinase delta (PI3K?) in patients with indolent B-cell non-Hodgkin's lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenstr?m's macroglobulinemia (WM) in Japan.



This Phase 2, multicenter, open-label, single-arm clinical study is conducted by Kyowa Kirin to evaluate zandelisib as monotherapy for treatment of Japanese patients with relapsed or refractory iNHL with at least two prior systemic therapies.

Yoshifumi Torii, Ph.D., Vice President, Head of R&D Division of Kyowa Kirin, said "I am pleased that we have initiated the clinical study to seek regulatory approval in Japan. We are committed to delivering zandelisib as a new potential treatment option for Japanese patients and their physicians. And we continue to work closely with MEI Pharma to expand the global development program for zandelisib."

"The initiation of the Japanese Phase 2 pivotal study is an important addition to the zandelisib global development program," stated Richard Ghalie, M.D., senior vice president, clinical development of MEI Pharma. "We are excited to continue working diligently in close partnership with Kyowa Kirin to build on the potential for zandelisib inside and outside the U.S., and to expand development into indications beyond follicular lymphoma."

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

<About the Clinical Study>

iNHL* Indication *SLL, WM and LPL are excluded

Phase Phase 2

Design Multicenter, open-label and single-arm study

Administration group Zandelisib monotherapy

Primary Endpoint Objective response rate (ORR)

Sample size 60

Estimated study completionSeptember 2024

Countries/Regions Japan

About Zandelisib