{"id":44935,"date":"2022-06-10T09:02:14","date_gmt":"2022-06-10T07:02:14","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/mei-pharma-and-kyowa-kirin-report-clinical-data-on-zandelisib-at-european-hematology-association-2022-hybrid-congress\/"},"modified":"2022-06-10T09:02:14","modified_gmt":"2022-06-10T07:02:14","slug":"mei-pharma-and-kyowa-kirin-report-clinical-data-on-zandelisib-at-european-hematology-association-2022-hybrid-congress","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/mei-pharma-and-kyowa-kirin-report-clinical-data-on-zandelisib-at-european-hematology-association-2022-hybrid-congress\/","title":{"rendered":"MEI Pharma and Kyowa Kirin Report Clinical Data on Zandelisib at European Hematology Association 2022 Hybrid Congress"},"content":{"rendered":"
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\n\u2013 Zandelisib Demonstrated 70.3% Objective Response Rate and 35.2% Complete Response Rate \u2013<\/i>\n<\/p>\n

\n\u2013 87.5% of Responses Achieved in First Two Cycles of Therapy, 75% of Complete Responses in first four cycles \u2013<\/i>\n<\/p>\n

\n\u2013 9.9% of Patients Discontinued Therapy Due to a Drug Related Adverse Event \u2013<\/i>\n<\/p>\n

\n\u2013 Primarily, Grade 3 AESIs to Date Occurred in Cycles 1-3. \u2013<\/i>\n<\/p>\n

SAN DIEGO & TOKYO–(BUSINESS WIRE)–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 that data from the zandelisib clinical development program, including the Phase 2 TIDAL study evaluating the intermittent dosing of zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta (“PI3K\u03b4”) inhibitor in clinical development for the treatment of B-cell malignancies, is highlighted in a poster and an oral discussion session at the European Hematology Association 2022 Hybrid Congress.\n<\/p>\n

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\n\u201cWhile many patients with indolent non-Hodgkin\u2019s lymphomas, such as follicular lymphoma, achieve durable responses with current standard of care therapies, patients generally continue to need multiple treatments throughout the course of their disease due to relapse, necessitating the development of novel treatment options,\u201d stated Professor Wojciech Jurczak, M.D., Ph.D. Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology in Krak\u00f3w, Poland, presenter of the Phase 2 TIDAL study oral presentation and the Phase 3 COASTAL study principal investigator. \u201cI believe the data presented at EHA this year are very exciting and supportive of the zandelisib development program, particularly as we continue to enroll the Phase 3 COASTAL study evaluating zandelisib in combination with rituximab.\u201d\n<\/p>\n

\nClinical Data from the Phase 2 TIDAL Study Evaluating Zandelisib in Patients with Relapsed or Refractory Follicular Lymphoma<\/b>\n<\/p>\n

\nOral Presentation Title:<\/b> Efficacy and Safety of Zandelisib Administered by Intermittent Dosing (ID) in Patients with Relapsed or Refractory (r\/r) Follicular Lymphoma: Primary Analysis of the Global Phase 2 Study TIDAL
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Session Title:<\/b> Indolent & mantle cell non-Hodgkin lymphoma \u2013 Clinical
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Presenter:<\/b> Wojciech Jurczak, PhD, MD
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Time:<\/b> June 11, 11:30am-12:45pm CEST
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Abstract Code:<\/b> S208\n<\/p>\n

\nStudy Details<\/span><\/b>\n<\/p>\n

\nThe 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 regimen, followed thereafter by once daily dosing for the first seven days of each subsequent 28-day cycle, an intermittent dosing (ID) regimen. The ID regimen was introduced to potentially allow Treg repopulation and to mitigate immune-mediated adverse events of special interest (AESI) without loss of disease control.\n<\/p>\n

\nEnrollment 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).\n<\/p>\n

\nThe 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 \u22655 cm, and 68 patients (56%) were POD24 (progression of disease within 24 months of prior chemoimmunotherapy).\n<\/p>\n

\nThe primary efficacy endpoint is ORR as assessed by an 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 primary efficacy population (PEP) received their first dose of zandelisib. Data from the enrolling MZL cohort is not reported.\n<\/p>\n

\nEfficacy<\/b>\n<\/p>\n

\nThe primary endpoint of ORR of zandelisib as a single agent in the PEP was 70.3% (N=64) as assessed by IRC; the complete response rate was 35.2% (N=32). Responses across sub-groups at high risk were all >63%:\n<\/p>\n