BeOne Medicines ((ONC)) announced an update on their ongoing clinical study.
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BeOne Medicines (ONC) is currently recruiting participants for a Phase 3 study titled A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator’s Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent BTK Inhibitors. The study aims to evaluate the efficacy and safety of BGB-16673 against standard treatment options in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with covalent Bruton tyrosine kinase inhibitors (cBTKi).
The study tests BGB-16673, an oral drug, against a combination of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab, which are administered intravenously. The goal is to determine if BGB-16673 offers a superior treatment option for these patients.
This interventional study is randomized and follows a parallel assignment model without masking, focusing primarily on treatment. Participants in Arm A receive BGB-16673 monotherapy, while those in Arm B receive the investigator’s choice of standard treatments. The study allows crossover to BGB-16673 for participants with confirmed disease progression.
The study began on May 6, 2025, with the latest update submitted on September 23, 2025. These dates are crucial as they mark the study’s progression and ongoing recruitment status, indicating active research and potential future results.
The outcome of this study could significantly impact BeOne Medicines’ stock performance and investor sentiment, especially if BGB-16673 proves more effective than existing treatments. This could position BeOne as a leader in CLL and SLL treatment, affecting competitors in the oncology market.
The study is ongoing, with further details available on the ClinicalTrials portal.