BeOne Medicines Advances Three Solid Tumor Programs with Promising ASCO 2026 Data
核心洞察
BeOne Medicines (搜索) presented encouraging clinical data for three differentiated oncology assets at ASCO 2026, spanning breast, gynecologic, and gastrointestinal cancers.
The CDK4 (搜索) inhibitor BGB-43395 demonstrated response rates of 63-68% in first-line HR+/HER2- metastatic breast cancer (搜索) with favorable safety profile, supporting advancement to Phase 3 trials.
The B7-H4 (搜索) ADC BG-C9074 showed 45.5% confirmed response rates in ovarian cancer (搜索) and the GPC3x4-1BB bispecific BGB-B2033 achieved 28.9% response rates in heavily pretreated hepatocellular carcinoma (搜索) patients.
BeOne Medicines (搜索) presented compelling clinical data for three distinct solid tumor programs at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating significant progress across its oncology pipeline. The data span breast, gynecologic, and gastrointestinal cancers, with each program advancing rapidly toward pivotal development phases.
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne Medicines (搜索), characterized 2026 as "an inflection year for BeOne's solid tumor portfolio, marked by the encouraging data we are presenting at ASCO combined with upcoming readouts at other major congresses."
CDK4 Inhibitor Shows Strong Efficacy in Breast Cancer
BeOne's highly selective CDK4 (搜索) inhibitor, BGB-43395, demonstrated promising anti-tumor activity in first-line HR+/HER2- metastatic breast cancer (搜索) when combined with letrozole. The compound showed a differentiated safety profile characterized by infrequent low-grade hematologic toxicities and manageable gastrointestinal events.
Key efficacy results included confirmed overall response rates (ORR) of 68.4% (95% CI: 43.4-87.4) for the 240 mg dose and 63.2% (95% CI: 38.4-83.7) for the 400 mg dose, both in combination with letrozole. Unconfirmed ORR reached 73.7% (95% CI: 48.8-90.9) for both dose levels.
The safety profile supported the molecule's high selectivity for CDK4 (搜索), with Grade ≥3 neutropenia reported in only 5.3% of patients at the 240 mg dose level and 0% at 400 mg. Gastrointestinal treatment-related adverse events were mitigated when administered with food, all of which were Grade 1. Median study follow-up ranged from 10.8 to 12.5 months across dose groups.
These findings have prompted BeOne to initiate KANDELA-302 (NCT07492641), a global, randomized Phase 3 clinical trial with BGB-43395 in combination with letrozole in first-line HR+/HER2- metastatic breast cancer (搜索), with patient enrollment beginning this month.
B7-H4 ADC Demonstrates Activity Across Tumor Types
The B7-H4 (搜索)-targeting antibody-drug conjugate (ADC) BG-C9074 showed encouraging efficacy signals in Phase 1 dose-escalation and safety-expansion cohorts. At doses under consideration for future development, the compound achieved confirmed ORR of 45.5% and unconfirmed ORR of 54.5% in ovarian cancer (搜索), with 40.0% response rates in triple-negative breast cancer (搜索). Median study follow-up was 6.6 months (range, 0.3-20.8 months).
Notably, anti-tumor activity was demonstrated in ovarian cancer (搜索) regardless of B7-H4 (搜索) expression level. Treatment was generally well tolerated with low discontinuation rates below 5%. Grade ≥3 treatment-related adverse events occurred in 31.5% of patients, with no Grade ≥3 nausea at 6 mg/kg adjusted ideal body weight (AIBW) and only 1.2% at 8 mg/kg AIBW.
The AIBW-based dosing approach used in the ongoing Phase 1 study effectively reduced pharmacokinetic variability compared with total body weight dosing. These results support continued advancement of BG-C9074, with development efforts focused on early-line ovarian cancer (搜索) and additional B7-H4 (搜索)-expressing tumor types.
First-in-Class Bispecific Shows Promise in Liver Cancer
BGB-B2033, a GPC3x4-1BB bispecific antibody, delivered the first clinical data highlighting its potential as a first-in-class treatment for advanced solid tumors, particularly heavily pretreated hepatocellular carcinoma (搜索) (HCC). The molecule was rationally designed to target GPC3 (搜索)-expressing tumors, addressing a significant unmet need in HCC, which represents the sixth most prevalent cancer and third leading cause of cancer death worldwide, with five-year survival rates of only approximately 20%.
At doses ≥300 mg, BGB-B2033 achieved confirmed ORR of 28.9% and unconfirmed ORR of 31.6%, with median study follow-up of 4.8 months (range, 0.3-15.5 months). The treatment was generally well tolerated across all dose levels (1-1000 mg every three weeks) with no significant dose-dependent increase in treatment-emergent adverse events.
Safety data from 61 patients showed that 68.9% experienced treatment-emergent adverse events, with 47.5% being treatment-related. Only 8.2% of patients experienced Grade ≥3 treatment-related adverse events, and treatment discontinuation due to adverse events occurred in just 3.3% of patients. Treatment-related adverse events occurring in more than 5% of patients were limited to increases in alanine aminotransferase and aspartate aminotransferase, both occurring at Grade ≥3 in only 1.6% of patients.
Regulatory Recognition and Future Development
BGB-B2033 has received significant regulatory recognition, with the FDA granting Fast Track Designation in December 2025 for HCC treatment, followed by Orphan Drug Designation in March 2026. BeOne has announced the initiation of a potentially registration-enabling pivotal study in late-line HCC and planned expansion into earlier lines of therapy and additional tumor types.
The company's strategy of "pairing the right biology with the right modality" appears to be validating across multiple programs, supporting advancement of several assets into pivotal trials throughout 2026. BeOne's global oncology platform spans hematology and solid tumors, with internal capabilities and collaborations expediting development of its diverse therapeutic pipeline.