BeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal Cancer

BeOne Medicines reported results from its HERIZON-GEA-01 Phase 3 trial, showing median overall survival of 27.0 months for TEVIMBRA plus ZIIHERA and chemotherapy, with a hazard ratio of 0.65. ZIIHERA plus chemotherapy alone showed 22.9 months. The trial met a primary endpoint with a p-value of 0.0088. The study involved 914 patients across 30 countries, with no new safety signals identified.

BeOne Medicines presented data from its solid tumor pipeline at ESMO 2026, including updates on GPC3x4-1BB bispecific antibody, CEA targeting ADC, CDK4 inhibitor, and PRMT5 inhibitor. The company also shared evidence for TEVIMBRA in lung and gastrointestinal cancers, including a combination with ZIIHERA in HER2+ gastroesophageal adenocarcinoma. BeOne aims to advance these therapies toward pivotal development.

BeOne Medicines (ONC) announced FDA approval for TEVIMBRA in combination with ZIIHERA and chemotherapy for HER2-positive gastroesophageal adenocarcinoma. The approval is based on Phase 3 trial data showing a median survival of 26.4 months. The company reported Q2 2026 revenue of $1.7 billion, up 30% YoY, and raised full-year revenue guidance to $6.6B-$6.8B. However, a Phase 3 study for zanubrutinib-sonrotoclax combination did not meet its primary endpoint.

President Trump's administration signed drug-pricing agreements with nine mid-sized pharmaceutical companies, including Astellas Pharma, Teva, and UCB, to lower U.S. drug prices under the MFN proposal. Companies agreed to reduce prices and invest $19.6B in U.S. manufacturing, with some contributing APIs to a government reserve. The deals cover 89% of the branded drug market, expanding beyond initial Big Pharma focus.

BeOne Medicines (ONC) reported positive Phase III trial results for Ziihera, showing improved overall survival in HER2+ gastroesophageal cancer patients when combined with chemotherapy. The study met its primary endpoint, demonstrating statistical significance and clinical benefit over trastuzumab plus chemotherapy.

President Trump announced drug pricing agreements with nine pharmaceutical companies, including Alcon (ALC), BeOne (ONC), BridgeBio (BBIO), and Teva (TEVA). The deals require discounts on outpatient drugs for Medicaid and $19.6B in U.S. manufacturing investments. This expands the total to 26 companies, covering 90% of the U.S. market. The White House estimates $529B in savings over a decade.