– Zandelisib Demonstrated 70.3% Objective Response Rate and 35.2% Complete Response Rate –
– 87.5% of Responses Achieved in First Two Cycles of Therapy, 75% of CRs in First Four Cycles –
– 9.9% of Patients Discontinued Therapy Due to a Drug Related Adverse Event –
– 83% Reported Grade 3 Adverse Events of Special Interest in Cycles 1-3 –
MEI Pharma, Inc. (NASDAQ:MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), 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.
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“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, MD, 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.”
Clinical Data from the Phase 2 TIDAL Study Evaluating Zandelisib in Patients with Relapsed or Refractory Follicular Lymphoma
Presentation Title: Efficacy and safety of zandelisib administered by intermittent dosing (ID) in patients with relapsed or refractory (R/R) follicular lymphoma (FL): Primary analysis of the global phase 2 study TIDAL
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Andrew David Zelenetz, Ph.D., MD
Date and Time: Saturday, June 4, 2022, at 3:00 Central Time
Poster ID: 7511 / 165
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.
The FL cohort enrolled a total of 121 patients, with the first 91 consisting of the primary efficacy population (PEP) for the evaluation of overall response rate (ORR) and duration of response (DOR).
The median age of patients enrolled with FL was 64 years old. Enrolled patients were generally heavily pretreated; the median number of prior therapies was 3 (range 2-8) and 96% of patients had received prior chemoimmunotherapy. Further, 28 patients (23 %) received prior stem cell transplant, 50 patients (41%) were refractory to last therapy, 41 patients (34%) had tumors ≥5 cm, and 68 patients (56%) were POD24 (progression of disease within 24 months of prior chemoimmunotherapy).
The primary efficacy endpoint is ORR as assessed by independent review committee (IRC) using a modified Lugano criteria. The data cutoff date is September 30, 2021, approximately 6 months after the last patient in the PEP received their first dose of zandelisib. Data from the enrolling MZL cohort is not reported.
The primary endpoint of ORR of zandelisib as a single agent in the PEP was 70.3% (N=64), 95% CI=59.8, 79.5, as assessed by IRC; the complete response rate was 35.2% (N=32), 95 % CI=25.4, 45.9. Responses across sub-groups (ie response to last treatment, number of prior therapies and POD24) were all >63%.
Response Rates by Independent Review Committee in All PEP Patients and by Subgroup