BeOne Reports Promising Data Across Liver and Lung Cancers

SAN CARLOS, Calif. — October 24, 2026

BGB-B2033 Shows Durable Responses in Advanced Liver Cancer

BGB-B2033 is an investigational bispecific antibody designed to target glypican 3 (GPC3) on tumor cells and activate 4-1BB, a costimulatory receptor involved in T-cell activation. The approach is intended to concentrate immune activation in GPC3-expressing tumors while limiting systemic toxicity. The updated Phase 1 results presented at ESMO 2026 included 94 patients with advanced HCC. The population was heavily pretreated: 93.6% had previously received PD-(L)1 therapy, and 61.7% had received both PD-(L)1 therapy and a tyrosine kinase inhibitor (TKI). At the selected Phase 3 dose of 450 mg every three weeks, the confirmed ORR was 36.0%. The estimated six-month confirmed duration-of-response rate was 74.1%, suggesting that responses could be maintained in a proportion of patients. Responses were reported across clinically relevant patient subgroups. Across dose levels, Grade 3 or higher treatment-related adverse events occurred in 5.3% of patients, while treatment-related adverse events led to discontinuation in 2.1%. These safety findings are relevant in advanced HCC, where underlying liver disease can complicate treatment. However, the results come from an early-phase study and do not establish comparative efficacy against other therapies. BGB-B2033 received U.S. Food and Drug Administration (FDA) Fast Track Designation in December 2025 and Orphan Drug Designation from the FDA in March 2026 and the European Commission in October 2026 for HCC. BeOne plans to initiate global registrational trials in late-line HCC by the end of 2026 and is also considering development in earlier treatment settings. The company views GPC3-directed immune activation as a potential strategy for patients whose disease has progressed after immunotherapy, an area with continuing unmet medical need.

BGB-58067 and BG-C477 Advance BeOne’s Lung Cancer Pipeline

BeOne also presented initial clinical findings from two investigational medicines with distinct mechanisms for NSCLC. BGB-58067 is an oral, brain-penetrant inhibitor of protein arginine methyltransferase 5 (PRMT5), designed to exploit the vulnerability of cancers with methylthioadenosine phosphorylase (MTAP) deficiency. Initial Phase 1 findings from 182 patients across MTAP-deficient solid tumors included 83 patients with NSCLC. Among 75 efficacy-evaluable patients with MTAP-deficient NSCLC, the confirmed ORR was 25.3%, and the disease control rate (DCR) was 76.0%. In the EGFR wild-type subgroup, confirmed ORR was 38.5% and DCR was 82.1%. Median progression-free survival was 7.7 months in the overall NSCLC cohort and 8.1 months in the EGFR wild-type subgroup. The study also reported an intracranial ORR of 30.8% among patients with untreated, asymptomatic brain metastases, alongside a low rate of central nervous system progression in second-line-or-later NSCLC. At daily doses of 200–400 mg, Grade 3 or higher treatment-related adverse events occurred in 27.6% of 87 patients, and treatment-related adverse events led to discontinuation in 5.7%. Common treatment-related events included nausea, anemia and fatigue. Separately, BG-C477, BeOne’s internally developed CEA-targeting ADC, is designed to deliver a topoisomerase I inhibitor payload to tumor cells expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). Preliminary Phase 1 results available as of April 9, 2026, included 43 heavily pretreated patients with NSCLC, 25 of whom had high CEA expression. In the CEA-high subgroup, confirmed ORR was 56.0%, with a DCR of 88.0%; confirmed ORR across the overall NSCLC population was 34.9%. Median duration of response had not been reached in the CEA-high group at the data cutoff, and most responders remained on treatment. Grade 3 or higher treatment-emergent adverse events were predominantly hematologic, including anemia and neutropenia, each reported in 14.0% of the overall 43-patient population, and thrombocytopenia in 2.3%. Updated BG-C477 results were scheduled for presentation at ESMO on October 26, 2026. The program received FDA Fast Track Designation in October 2026. Both lung cancer programs are intended to advance toward later-stage development in 2027, subject to further clinical evaluation.

Phase 3 Breast Cancer Study Expands Development Strategy

Beyond liver and lung cancer, BeOne is advancing BGB-43395, an investigational selective cyclin-dependent kinase 4 (CDK4) inhibitor, in the global Phase 3 KANDELA-302 study. The trial is evaluating BGB-43395 plus letrozole against investigator-selected abemaciclib, palbociclib or ribociclib, each combined with letrozole, in patients with first-line hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) advanced or metastatic breast cancer. Enrollment began in May 2026, with participation planned across North and South America, Europe, Asia and Australia. The primary endpoint is progression-free survival assessed by blinded independent central review, while overall survival is the key secondary endpoint. BGB-43395 is designed to provide selective CDK4 inhibition, and the company is investigating whether this approach could offer a different tolerability profile compared with currently used CDK4/6 inhibitors. Such potential benefits have yet to be established in the Phase 3 setting. BeOne Chief Medical Officer for Solid Tumors Mark Lanasa, M.D., Ph.D., said the ESMO presentations reflect the company’s strategy of matching therapeutic modalities to the biology of individual cancers. The company is continuing to develop a broad oncology portfolio spanning hematologic malignancies and solid tumors, using internal research capabilities and collaborations. The combined findings across BGB-B2033, BGB-58067, BG-C477 and BGB-43395 demonstrate activity across several investigational programs, but the evidence varies by study phase, patient population and follow-up duration. Further trials will be needed to confirm efficacy, characterize safety and determine each medicine’s potential role in clinical practice.

Source: BeOne Medicines ,Press release