Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Phosphatidylinositol 3-kinase-δ inhibitor
HMPL-689 · 2 trials · 3 indications
Defined as the proportion of patients with CR or PR
Incidence of dose limited toxicities and associated dose of HMPL-689
Overall response rate (ORR) is defined as the proportion of patients who have a CR or PR
| Arm | Type | Description |
|---|---|---|
| Relapsed/Refractory MZL and FL | EXPERIMENTAL | Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma |
| Six arm including in dose expansion stage by following: | EXPERIMENTAL | * Arm A: patients with MZL (subtype including nodal, extra-nodal and splenic) who received ≥ 1 previous line of systematic treatment and at least one line included CD20-directed regimen * Arm B: patients with CLL/SLL who received ≥ 1 previous line of systematic treatment and at least one of which included purine-based regimen or CD20-directed regimen * Arm C: patients with FL (grade 1, 2, and 3a) who received ≥ 2 previous line of systematic treatment and at least one line included CD20-directed regimen * Arm D: patients with MCL who received ≥ 2 previous line of systematic treatment and at least one line included CD20-directed regimen * Arm E: patients with DLBCL (including GCB and non-GCB, Richter' transformation) who received ≥ 2 previous line of systematic treatment and at least one line included CD20-directed regimen * Arm F: patients with PTCL who received ≥ 2 previous line of systematic treatment |
| Name | Type | Description |
|---|---|---|
| HMPL-689 | DRUG | All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles. |
Inclusion Criteria: 1. Age ≥18 years; 2. Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2; 4. At least one measurable lesion by computerised tomography (CT) / magnetic resonance imaging (MRI) (t...
HMPL-689 is an investigational small molecule being studied for the treatment of lymphomas, including marginal zone lymphoma and follicular lymphoma. It is being developed for patients with relapsed or refractory disease. HMPL-689 has not been approved for any indication and remains in clinical development.
HMPL-689 targets PI3K, a class of enzyme targets. PI3K, or phosphoinositide 3-kinase, is a lipid kinase involved in cell signaling pathways that regulate growth and survival in lymphoma cells. By inhibiting PI3K, HMPL-689 is designed to interfere with those signaling pathways in B-cell malignancies.
HMPL-689 is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is running the clinical development program for the drug in lymphoma indications, including marginal zone lymphoma and follicular lymphoma, with trials conducted in China.
HMPL-689 is in Phase 1 development. A Phase 1 study in patients with lymphomas has been completed, and a Phase 2 study in marginal zone lymphoma and follicular lymphoma has also been completed. HMPL-689 is investigational and has not been approved by the FDA or any regulatory authority.
HMPL-689 has been evaluated in two completed clinical trials. NCT03128164 was a Phase 1 study in patients with lymphomas who had failed standard of care or had no standard of care available, enrolling 200 patients. NCT04849351 was a Phase 2 study in relapsed or refractory marginal zone lymphoma and follicular lymphoma, enrolling 178 patients in China.
HMPL-689 is being studied in lymphomas, with specific development in marginal zone lymphoma and follicular lymphoma. The Phase 2 trial NCT04849351 enrolled patients with relapsed or refractory marginal zone lymphoma and follicular lymphoma, while the Phase 1 trial NCT03128164 enrolled patients with lymphomas more broadly.