The company has completed the patient enrollment in the P-II registration trial evaluating the efficacy & safety of amdizalisib as monotx. in 108 patients with r/r FL or MZL in ~35 sites in China
The 1EPs of the trial is ORR & the 2EPs incl. CRR, PFS, time to response, and DoR. The results are expected in H2’23
If the results from the P-II trial are positive, the company plans for marketing authorization of amdizalisib for r/r FL in China. Amdizalisib (HMPL-689) is a novel, selective, and potent oral inhibitor targeting the isoform PI3Kδ & is being studied in the P-II study in combination with tazemetostat (a methyltransferase inhibitor of EZH2) for r/r lymphoma
Ref: Globenewswire | Image: HUTCHMED
Related News:- Hutchmed’s Amdizalisib (HMPL-689) Receives Breakthrough Therapy Designation for the Treatment of R/R Follicular Lymphoma in China
