News & Events zu BeOne Medicines AG (ONC)ONCBeOne Medicines AG

BeOne Medicines Announces New Drug Data at ESMO 2026

BeOne Medicines announced new data from multiple differentiated investigational medicines across its priority solid tumor disease areas at the European Society for Medical Oncology, ESMO, Congress 2026. Potential first-in-class GPC34-1BB bispecific continues to demonstrate compelling and durable activity in heavily pretreated HCC - Updated Phase 1 results include: At the recommended Phase 3 dose of 450 mg every three weeks, the confirmed objective response rate was 36.0%, a result that exceeds efficacy observed with TKIs, which have shown an ORR of approximately 5% in late-line HCC; At the selected Phase 3 dose, the estimated six-month confirmed duration-of-response rate was 74.1%, with responses observed across all clinically relevant patient subgroups; Across dose levels, Grade 3 or higher treatment-related adverse events occurred in 5.3% of patients, and treatment-related adverse events led to discontinuation in only 2.1%. Initial first-in-human data from two differentiated assets advance BeOne's emerging NSCLC portfolio. Brain-penetrant PRMT5 inhibitor, BGB-58067, demonstrates systemic and intracranial activity in MTAP-deficient NSCLC - initial Phase 1 findings showed: Among 75 efficacy-evaluable patients with MTAP-deficient NSCLC, confirmed ORR was 25.3% and disease control rate was 76.0%. Median progression-free survival was 7.7 months in the overall NSCLC cohort and 8.1 months in the EGFR wild-type subgroup. CEA-targeting ADC BG-C477 achieves "encouraging" response rate in previously-treated CEAhigh NSCLC - preliminary Phase 1 monotherapy findings showed: Confirmed ORR was 56.0% in patients with CEAhigh NSCLC, with a disease control rate of 88.0%; confirmed ORR in the overall NSCLC population was 34.9%. Grade 3 or higher treatment-emergent adverse events were predominantly hematologic events.

BeOne Medicines Releases New Survival Results from HERIZON-GEA-01 Trial

BeOne Medicines announced new survival results from the planned second interim analysis and final formal analysis of the Phase 3 HERIZON-GEA-01 trial, further confirming the benefit of TEVIMBRA plus ZIIHERA and chemotherapy as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. The results will be presented today as a late-breaking abstract during a rapid oral session at the European Society for Medical Oncology Congress 2026 in Madrid, Spain. This new analysis was conducted after 35.3 months of follow-up, an additional 9.4 months since the first interim analysis. Formal overall survival comparisons were tested sequentially, first comparing ZIIHERA plus chemotherapy with trastuzumab plus chemotherapy and then comparing TEVIMBRA plus ZIIHERA and chemotherapy with ZIIHERA plus chemotherapy. Key findings include: TEVIMBRA plus ZIIHERA and chemotherapy demonstrated sustained long-term survival versus trastuzumab plus chemotherapy. Median OS was 27.0 months, with an OS hazard ratio of 0.65, improved from 0.72 at the first interim analysis. This regimen is the only treatment for patients with HER2+ GEA to show a median overall survival of more than two years. ZIIHERA plus chemotherapy significantly improved OS versus trastuzumab plus chemotherapy. Median OS was 22.9 months versus 19.6 months, respectively, meeting the remaining primary endpoint of the study. Adding TEVIMBRA to ZIIHERA plus chemotherapy was associated with a four-month longer median OS at 27.0 months compared with ZIIHERA plus chemotherapy with 22.9 months. The difference did not reach statistical significance in the context of an underpowered analysis. A consistent trend toward improved OS was observed irrespective of PD-L1 status. Long-term survival was highest with the TEVIMBRA-containing regimen. Estimated 36-month OS was 39.8% with TEVIMBRA plus ZIIHERA and chemotherapy, 31.5% with ZIIHERA plus chemotherapy and 22.9% with trastuzumab plus chemotherapy. TEVIMBRA plus ZIIHERA and chemotherapy significantly improved progression-free survival versus trastuzumab plus chemotherapy, with median PFS of 12.7 months versus 8.3 months. Median PFS with ZIIHERA plus chemotherapy was 12.4 months versus trastuzumab plus chemotherapy. The safety findings for both experimental arms were generally consistent with the first interim analysis, and with the known profiles of the component therapies. No new safety signals were identified, and diarrhea was the most common Grade greater than or equal to3 treatment-related adverse event. A mandatory anti-diarrheal prophylaxis was established during the first cycle, with most diarrhea events occurring early in the treatment.

BeOne Medicines Announces Agreement with U.S. Government to Expand Access to Cancer Medicines

BeOne Medicines announced a voluntary agreement with the U.S. Government to "expand access to innovative cancer medicines for American patients while strengthening our U.S manufacturing footprint and further expanding the capabilities needed to deliver medicines at scale." The company said: "The agreement builds on BeOne's longstanding commitment to patient access and investment in research and scientific innovation. This announcement reflects BeOne's participation in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model and the company's commitment to pricing future FDA-approved products in line with other key developed markets." John Oyler, Co-Founder, Chairman and CEO, BeOne Medicines, said: "At BeOne, we believe every patient should benefit from innovative cancer therapies. We appreciate the Trump Administration's commitment to advancing solutions that broaden access and scientific progress for American patients. This agreement reflects our purpose to reach more patients as we expand our U.S. investment in additional research, development, and manufacturing to deliver breakthrough cancer treatments worldwide."