MEI Pharma, a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co, a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, today announced data from the ongoing Phase 2 TIDAL study evaluating the intermittent dosing of zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies, is highlighted in a poster and oral discussion session at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting. 

“The Phase 2 TIDAL data generated to date continue to highlight zandelisib's therapeutic profile and the potential to benefit patients, supporting our commitment to advancing the program and our already ongoing randomized Phase 3 COASTAL study with our partner, Kyowa Kirin," said Richard Ghalie, M.D., chief medical officer of MEI Pharma. "In light of the promising results from TIDAL to date, we remain committed to the zandelisib program with our primary focus being on COASTAL, our ongoing Phase 3, randomized, study evaluating zandelisib in combination with rituximab in follicular and marginal zone lymphoma patients with at least one prior line of therapy.”

“We are very pleased to present data from Phase 2 TIDAL study in ASCO meeting,” said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. “We continue to see favorable profile of zandelisib that balances efficacy and safety. We remain committed to maximizing the value of zandelisib in B-cell malignancies with our partner MEI Pharma.”

The ongoing TIDAL study (NCT03768505) is a global, open-label Phase 2 trial evaluating zandelisib as a single agent in two disease cohorts: one in relapsed or refractory (r/r) follicular lymphoma (FL) and one for r/r marginal zone lymphoma (MZL), in both cases after failure of at least two prior systemic therapies, including chemotherapy and an anti-CD20 antibody. Patients were administered zandelisib once daily for two 28-day cycles as response induction therapy, followed thereafter by once daily dosing for the first seven days of each subsequent 28-day cycle, a schedule called Intermittent Dosing (ID). Enrollment in the FL cohort is complete; enrollment in the MZL cohort is ongoing.