BeOne Medicines reported a confirmed objective response rate of 36% for its experimental liver cancer treatment BGB-B2033 in updated Phase 1 results presented at the ESMO Congress 2026 in Madrid, the annual congress of the European Society for Medical Oncology and one of oncology’s leading venues for clinical data readouts. The company also presented early findings from studies of treatments for lung and breast cancer.

BeOne Medicines AG (NASDAQ: ONC) shares fell 1.21% to $377.63, a decline of $4.64, despite the new clinical data.

BGB-B2033 Shows 36% Response Rate in Liver Cancer Study

The updated Phase 1 results evaluated BGB-B2033 in patients with advanced hepatocellular carcinoma, the most common form of primary liver cancer, where approved options are limited once the disease progresses after immunotherapy. At the selected Phase 3 dose, the treatment produced a confirmed objective response rate of 36%. The result was above the approximately 5% response rates associated with certain late-line tyrosine kinase inhibitors.

The study included 94 patients. Of those participants, 93.6% had previously received PD-(L)1 immunotherapy, while 61.7% had received both immunotherapy and a tyrosine kinase inhibitor. At the selected dose, researchers estimated a six-month confirmed response durability rate of 74.1%.

Safety results included severe treatment-related adverse events in 5.3% of patients. Across all tested dose levels, 2.1% of participants discontinued treatment because of treatment-related complications. BeOne plans to begin global registrational trials before the end of 2026.

The FDA previously granted BGB-B2033 Fast Track and Orphan Drugations for liver cancer. Fast Track is intended to speed the development and review of therapies for serious conditions, while Orphan Drug status supports drugs developed for rare diseases.

Early Lung Cancer Findings Include Intracranial Responses

BeOne also presented initial findings for BGB-58067, an experimental PRMT5 inhibitor being developed for MTAP-deficient cancers, a genetic alteration that occurs across many tumor types. Among 75 evaluable lung cancer patients, the treatment produced a confirmed response rate of 25.3% and a disease control rate of 76%.

The response rate was 38.5% among patients with EGFR wild-type lung cancer. Across the broader non-small cell lung cancer cohort, median progression-free survival was 7.7 months. Researchers also recorded a 30.8% intracranial response rate among patients with untreated, asymptomatic brain metastases. Intracranial activity is a closely watched measure in lung cancer, where brain metastases are a frequent site of disease spread and many systemic therapies have limited reach in the brain.

Separately, BeOne reported results for BG-C477, an internally developed antibody-drug conjugate targeting CEA-expressing tumors. Among 25 patients with high CEA expression, the treatment generated a confirmed response rate of 56% and a disease control rate of 88%. The company plans additional clinical development during 2027.

Phase 3 Breast Cancer Trial Underway

BeOne is also advancing BGB-43395, an experimental selective CDK4 inhibitor. The company began enrolling patients in the global Phase 3 KANDELA-302 trial in May 2026.

The study is evaluating patients with HR-positive, HER2-negative advanced or metastatic breast cancer receiving first-line treatment, a setting in which CDK4/6 inhibitors combined with endocrine therapy are the established standard of care. Researchers will compare BGB-43395 combined with letrozole against three established CDK4/6 inhibitors, also combined with letrozole: abemaciclib, palbociclib, and ribociclib, giving the trial a head-to-head design against current practice.

Progression-free survival is the trial’s primary endpoint, while overall survival is a key secondary endpoint. The studies reported at ESMO add several development milestones to BeOne’s solid-tumor portfolio, which the company is expanding beyond its established blood cancer operations. Larger trials will be required to confirm the early treatment results.

Source: Blockonomi