BeOne Medicines reported durable responses with tacabrutideg and deep MRD-negative remissions with the BRUKINSA-sonrotoclax combination across multiple B-cell malignancies at EHA 2026.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
At EHA 2026, BeOne Medicines presented updated data that further strengthen the clinical potential of its hematology portfolio, with the investigational BTK degrader tacabrutideg (BGB-16673) and the all-oral combination of BRUKINSA® (zanubrutinib) and BEQALZI™ (sonrotoclax) delivering durable responses across multiple B-cell malignancies.
The findings highlight two key treatment goals increasingly shaping the field: overcoming resistance in heavily pretreated patients and achieving deeper remissions that may support treatment-free approaches.
“Targeted protein degradation represents the next major advance beyond BTK inhibition in B-cell malignancies,” said Dr. Amit Agarwal, Chief Medical Officer of Hematology at BeOne Medicines. He noted that tacabrutideg has generated durable responses in heavily pretreated patients while also demonstrating encouraging activity in earlier treatment settings.
Durable Responses in High-Risk CLL
Updated results from the Phase 1/2 CaDAnCe-101 study (NCT05006716) showed that tacabrutideg continued to deliver meaningful and durable clinical benefit in relapsed/refractory CLL/SLL. Among 67 patients, the BTK degrader achieved an ORR of 85.1%, a median duration of response of 20.7 months, and a 24-month PFS rate of 53.8%, with responses occurring in a median of 2.8 months. The study included patients with high-risk disease characteristics, including del(17p)/TP53 mutations, unmutated IGHV, complex karyotype, and BTK resistance mutations. Investigators also reported rapid and sustained improvement in cytopenias among responding patients, with no treatment-related deaths observed.
The agent also demonstrated encouraging efficacy in relapsed/refractory Waldenström macroglobulinemia, achieving a major response rate of 76.3%, including a very good partial response rate of 30.2%. At 15 months, 70.4% of patients remained progression-free.
Earlier-Line Treatment Potential
Beyond the relapsed/refractory setting, the first evaluation of tacabrutideg in BTK inhibitor–naïve patients suggested potential earlier-line utility. Among 22 evaluable patients with CLL/SLL, the therapy achieved an ORR of 86.4%, with no disease progression reported at six months and no reported opportunistic infections, major hemorrhage, or febrile neutropenia.
Deep MRD-Negative Remissions
While tacabrutideg aims to address resistance, the zanubrutinib-sonrotoclax combination continues to push the boundaries of response depth. In treatment-naïve CLL, updated data from the Phase 1/1b BGB-11417-101 study (NCT04277637) showed a 100% ORR, a complete response rate of 59.5%, and a best uMRD4 rate of 98.8%. Deep remissions were also observed in patients with TP53 mutations or del(17p), with a best uMRD4 rate of 92.9%. No patient who achieved uMRD4 reverted to MRD positivity, and investigators reported a median time to uMRD4 of 4.5 months. No disease progression was observed after 34.1 months of follow-up.
Durable Activity Across B-Cell Malignancies
The combination produced similarly strong outcomes in relapsed/refractory CLL, delivering a 100% ORR, an 85% best uMRD4 rate, and a 36-month PFS rate of 95.5%, with no reversion to MRD positivity among patients who achieved uMRD4. In relapsed/refractory mantle cell lymphoma, the regimen achieved an ORR of 82%, including complete responses in 59% of patients.
The latest EHA data position tacabrutideg and the zanubrutinib-sonrotoclax combination as complementary approaches with the potential to reshape treatment paradigms. With more than 1,200 patients treated globally, tacabrutideg has received FDA Fast Track and EMA PRIME designations and is being evaluated in three randomized Phase 3 trials, including a head-to-head study against pirtobrutinib. Meanwhile, sonrotoclax has been evaluated in more than 2,500 patients worldwide, and zanubrutinib has treated over 290,000 patients across multiple B-cell malignancies.
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About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.