Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
zanubrutinib maintenance until disease progression · 1 trial · 1 indication
Proportion of patients achieving undetectable minimal residual disease (uMRD, defined as MRD \<10-⁴, fewer than 1 CLL cell per 10,000 leukocytes)
| Arm | Type | Description |
|---|---|---|
| Low-risk group（Without del17p and/or TP53 mutation） | EXPERIMENTAL | 12 cycles of zanubrutinib monotherapy induction → 12 cycles of zanubrutinib combined with sonrotoclax → discontinuation of study drugs followed by regular follow-up |
| High-risk group(With del17p and/or TP53 mutation) | EXPERIMENTAL | 12 cycles of zanubrutinib followed by 12 cycles of zanubrutinib in combination with sonrotoclax, then zanubrutinib maintenance monotherapy until disease progression or intolerable toxicity occurs. |
| Name | Type | Description |
|---|---|---|
| 12 cycles of zanubrutinib followed by 12 cycles of zanubrutinib in combination with sonrotoclax | DRUG | 12 cycles of zanubrutinib monotherapy induction → 12 cycles of zanubrutinib combined with sonrotoclax → discontinuation of study drugs followed by regular follow-up Zanubrutinib Dosage The total daily oral dose is 320 mg. The dosing schedule is 160 mg (2 × 80 mg capsules) twice daily, Sonrotoclax Dose Escalation Schedule Cycle 13 Week 1 (C13W1): Days 1-3: 1 mg daily (1 × 1 mg tablet); Days 4-7: 2 mg daily (2 × 1 mg tablets) Cycle 13 Week 2 (C13W2): Days 1-3: 5 mg daily (1 × 5 mg tablet); Days 4-7: 10 mg daily (2 × 5 mg tablets) Cycle 13 Week 3 (C13W3): Days 1-3: 20 mg daily (1 × 20 mg tablet); Days 4-7: 40 mg daily (2 × 20 mg tablets) Cycle 13 Week 4 (C13W4): Days 1-3: 80 mg daily (1 × 80 mg tablet); Days 4-7: 160 mg daily (2 × 80 mg tablets) Cycle 14 Week 1 (C14W1) and all subsequent cycles: 320 mg daily (4 × 80 mg tablets) |
| zanubrutinib maintenance until disease progression | DRUG | Continuous zanubrutinib monotherapy until disease progression or intolerable toxicity occurs. |
Inclusion Criteria: 1. Aged ≥18 years, no restriction on gender. 2. Newly diagnosed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) consistent with the Chinese Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (2025 Edition). 3. ...
Zanubrutinib maintenance until disease progression is being studied for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is an investigational small molecule kinase inhibitor currently in Phase 2 clinical development, with an ongoing trial evaluating its use in patients with CLL/SLL.
Zanubrutinib maintenance until disease progression targets kinases, as it belongs to the -tinib class of kinase inhibitors. The drug is designed to inhibit kinase activity, which plays a role in the signaling pathways that drive the growth and survival of cancer cells in CLL and SLL.
Zanubrutinib maintenance until disease progression is being developed by BeOne Medicines Ltd., a company listed under the ticker ONC. The company is conducting a Phase 2 clinical trial of the drug in patients with CLL/SLL.
Zanubrutinib maintenance until disease progression is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is currently not yet recruiting participants.
Zanubrutinib maintenance until disease progression is being evaluated in one Phase 2 clinical trial with the identifier NCT07682415. The trial, titled 'Zanubrutinib Induction Followed by Delayed Fixed-Duration Combination With Sonrotoclax for CLL/SLL: Stop Trial 2.0', is a controlled study enrolling 60 patients in China.
Zanubrutinib maintenance until disease progression refers to a specific treatment regimen involving zanubrutinib administered as maintenance therapy until disease progression occurs. It is not a distinct drug but rather a description of how zanubrutinib is being used in the clinical trial setting for CLL/SLL.