MEI Pharma, Kyowa Kirin Reveal Data From Zandelisib Trial In Follicular Lymphoma

MEI Pharma Inc MEIP and Kyowa Kirin Co Ltd have announced data from the pivotal Phase 2 TIDAL study of zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies.

• Data demonstrated a 70.3% objective response rate (ORR) as determined by Independent Review Committee (IRC) assessment in the primary efficacy population (n=91). 
• In addition, 35.2% of patients achieved a complete response. 
• The data are currently insufficiently mature to accurately estimate the duration of response (DOR). 
• The incidence of severe/serious adverse Events of Special Interest were: 1.7% liver enzymes elevation, 1.7% colitis, 5% diarrhea, 2.5% mucositis, 0.8% pneumonitis, and 3.3% rash. 
• The discontinuation rate due to any drug-related adverse event in the group was 9.9%.
• A complete report of the TIDAL data as of the data cutoff date will be submitted for presentation at upcoming scientific congresses in 2022.
• Zandelisib is an investigational selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor in clinical development to treat B-cell malignancies.
• Price Action: MEIP shares are up 14.10% at $2.79 during the market session on the last check Tuesday.