Kyowa Kirin and MEI Pharma Announce Topline Data from the Phase 2 MIRAGE Study Evaluating Zandelisib in Patients with Indolent B-cell non-Hodgkin’s Lymphoma in Japan
Interim data from Phase II Study of Zandelisib shows 75.4% ORR in Japanese patients with Indolent B-cell NHL –
– Publication of results from additional Phase 1 study now available in International Journal of Hematology–
Excerpt from the Press Release:
TOKYO & SAN DIEGO–(BUSINESS WIRE)–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 new therapies for cancer, today announced topline data from the Phase 2 MIRAGE study evaluating zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta (“PI3Kδ”) inhibitor, in patients with indolent B-cell Non-Hodgkin’s Lymphoma (iB-NHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) in Japan.
The data demonstrated a 75.4% objective response rate (ORR) and 24.6% of patients achieved a complete response (CR) as determined by Independent Review Committee (IRRC) assessment (n=61). The data is currently insufficiently mature to accurately estimate duration of response (DOR). With 9.5 months median duration of follow-up, a discontinuation rate due to any treatment emergent adverse event was 14.8%.
“We are very pleased to announce the data from Phase 2 MIRAGE study,” said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. “We continue to see a favorable profile of zandelisib with intermittent dosing that aims to balance efficacy and safety in Japanese patients who have been heavily pre-treated. These results are consistent with the data of the similarly designed TIDAL study already announced in November 2021. We remain committed to maximizing the value of zandelisib in B-cell malignancies with our partner MEI Pharma and bringing hope to lymphoma patients around the world.”
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