HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that new and updated clinical data related to two novel investigational therapies for hematological malignancies, HMPL-306 and amdizalisib, will be presented at the European Hematology Association (EHA) Annual Meeting and the 17th International Conference on Malignant Lymphoma (ICML).
HMPL-306: A Dual IDH1/2 Inhibitor
The data from HMPL-306, a first-in-human, dose-escalation study, involves patients with relapsed/refractory myeloid hematological malignancies harboring IDH1 and/or IDH2 mutations. Based on pharmacodynamic (PD), pharmacokinetic (PK), and preliminary clinical findings, a recommended Phase II dose has been nominated for the dose expansion phase of the study. HMPL-306 is a dual IDH1/2 inhibitor that targets specific mutations in hematological malignancies.
Amdizalisib (HMPL-689): A Selective PI3Kδ Inhibitor
Amdizalisib is a novel, selective, and potent oral inhibitor targeting the PI3Kδ isoform. Favorable PK properties, including good oral absorption, moderate tissue distribution, and low clearance in preclinical studies, suggest a low risk of drug accumulation and drug-to-drug interaction. Due to its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile. HutchMed revealed updated results from a Phase Ib study for amdizalisib in patients with various subtypes of non-Hodgkin’s lymphoma (NHL). The update includes more mature data from the FL cohorts, with a median follow-up duration of 22.1 months, and the presentation of PFS and DoR from the MZL cohort for the first time, at a median follow-up duration of 20.3 months.
Safety and Efficacy Data
Safety data were reported from 153 patients with a median exposure duration of 8.7 months. The most common treatment-emergent adverse events (TEAEs) of Grade ≥3 (≥5%) were pneumonia (15.7%), neutrophil count decreased (12.4%), lipase increased (7.8%), and rash (5.9%). The treatment discontinuation rate due to adverse events was 11.8%.-Fineline Info & Tech
