By Fineline Cube China-based biopharmaceutical company BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML). The data highlights the potential of Brukinsa in combination with obinutuzumab for the treatment of patients with heavily pretreated relapsed or refractory (R/R) follicular lymphoma (FL).
Phase II ROSEWOOD Trial Results
An updated analysis from the Phase II ROSEWOOD trial, shared as an oral presentation at ICML, demonstrated that the combination of Brukinsa and obinutuzumab showed clinically meaningful activity and was generally well-tolerated in patients with R/R FL. The combination therapy achieved an overall response rate of 69.0% compared to 45.8% in the obinutuzumab arm alone (p = 0.0012), with a median follow-up of 20.2 months. The complete response rate for the combination was 39.3% versus 19.4% for obinutuzumab alone. The non-hematologic treatment-emergent adverse events of any grade that occurred more frequently in the combination group were petechiae (6.3% vs. 0%) and herpes zoster infection (6.3% vs. 0%), while pyrexia (13.3% vs. 19.7%) and infusion-related reaction (2.8% vs. 9.9%) were more frequent in patients receiving obinutuzumab alone.
Global Approvals and Regulatory Updates for Brukinsa
Brukinsa received its first approval in the United States in November 2019 for the treatment of mantle cell lymphoma (MCL) in previously treated adult patients. In China, the drug was approved in June 2020 for both MCL and for previously treated adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Regulatory approvals were updated in May 2023 to include newly diagnosed CLL or SLL and newly diagnosed Waldenström’s macroglobulinemia (WM). Brukinsa has been approved in the US, EU, UK, Brazil, Peru, Israel, Canada, Switzerland, Latin America, and more.
BeiGene Responds to AbbVie’s Patent Infringement Lawsuit
In response to a lawsuit brought by US-based AbbVie Inc.’s subsidiary Pharmacyclics, alleging that Brukinsa infringed upon a recently awarded patent for Imbruvica (ibrutinib), US Patent No. 11,672,803 (the ’803 Patent), BeiGene has underlined the originality and differentiation of Brukinsa. The company highlighted that in the ALPINE study in R/R CLL/SLL, Brukinsa achieved superior efficacy and safety, including a lower incidence of atrial fibrillation, in a head-to-head comparison with Imbruvica.-Fineline Info & Tech