ONC News & Events

BeOne Medicines announced the presentation of a large Phase 3 dataset in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, CLL/SLL, aged 80 and older, showing sustained benefit with Brukinsa after nearly 6.5 years of follow-up, reinforcing its role as the foundational BTK inhibitor. Brukinsa is the only BTK inhibitor to demonstrate superior efficacy vs. ibrutinib in a Phase 3 trial. These data, one of the largest datasets of older patients with treatment-naive CLL, will be presented at the 2026 European Hematology Association, EHA, Congress in Stockholm, Sweden. Key highlights: Sequoia subgroup analysis showed that age did not limit benefit in patients with CLL treated with Brukinsa; 78-month Sequoia data reinforce Brukinsa as the "foundational BTK inhibitor" in CLL; Real-world efficacy and safety data consistently underscore "foundational Brukinsa as the best-in-class BTKi" for TN CLL

BeOne Medicines announced data from the HERIZON-GEA-01 trial, published in The New England Journal of Medicine and to be presented at the ASCO Annual Meeting on June 1 in Chicago, which evaluated Ziihera - zanidatamab - plus chemotherapy, with and without Tevimbra - tislelizumab -, compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma, or GEA. The regimen of tislelizumab added to zanidatamab plus chemotherapy demonstrated meaningfully improved outcomes for patients with HER2-positive GEA. Findings show that this regimen resulted in a survival benefit, even in patients with PD-L1 less than1%. A statistically significant and clinically meaningful improvement in OS with Ziihera plus Tevimbra and chemotherapy reached a median OS of 26.4 months. Progression-free survival showed a statistically significant and clinically meaningful improvement in both Ziihera-containing arms with a median PFS of 12.4 months. Median duration of response was 20.7 months with Ziihera and Tevimbra plus chemotherapy. The safety findings for the Ziihera plus Tevimbra and chemotherapy arm were generally consistent with known effects and no new safety signals were identified. The FDA has accepted a supplemental Biologics License Applications for Tevimbra and has granted it priority review. China's National Medical Products Administration has accepted sBLAs for Ziihera and Tevimbra for the first-line treatment of advanced/metastatic HER2+ GEA. BeOne holds the rights to Ziihera in Asia, Australia, and New Zealand, and intends to work with authorities in these markets to expedite regulatory submissions.