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<\/a><\/a>\nData from three differentiated BeOne pipeline assets will be presented, including:<\/p>
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- \nCDK4 inhibitor (BGB-43395)<\/b> (poster presentation): First disclosure of anti-tumor activity in first-line (1L) HR+\/HER2- metastatic breast cancer.<\/li>\n
- \nB7-H4 ADC (BG\u2011C9074)<\/b> (rapid oral presentation): Phase 1 dose-escalation and safety expansion data in advanced solid tumors.<\/li>\n
- \nGPC3x4-1BB (BGB-B2033)<\/b> bispecific antibody<\/b> (rapid oral presentation): First clinical data in advanced solid tumors, including hepatocellular carcinoma (HCC), the most common type of liver cancer.<\/li>\n<\/ul>
\nMark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said: <\/b>\u201c2026 is an inflection year for BeOne\u2019s solid tumor portfolio, marked by the encouraging data we are presenting at ASCO combined with upcoming readouts at other major congresses. These programs validate our strategy of pairing the right biology with the right modality, and support advancing several assets in different indications into pivotal trials in 2026.\u201d<\/p>
\nSelective CDK4 inhibitor shows promising efficacy and differentiated safety in first-line breast cancer (Poster Presentation: 180; June 1, 2026, 1:30 PM-4:30 PM CDT)<\/b>
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- \nThe 240 mg dose of BGB-43395 plus letrozole resulted in a confirmed overall response rate (ORR) of 68.4% (95% CI: 43.4\u201387.4) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9).<\/li>\n
- \nThe 400 mg dose plus letrozole resulted in a confirmed ORR of 63.2% (95% CI: 38.4\u201383.7) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9).<\/li>\n
- \nLow levels of hematologic treatment-related adverse events (TRAEs) with Grade \u22653 neutropenia reported in 5.3% of patients at the 240 mg dose level and 0% at 400 mg, as well as low frequency of fatigue and asthenia; supports profile and validates the molecule\u2019s high selectivity for CDK4.<\/li>\n
- \nGI TRAEs were mitigated when administered with food, all of which were Grade 1.<\/li>\n
- \nMedian study follow-up was 12.5 (range, 3.1-15.2) months, 12.4 (range, 8.0-15.0) months, and 10.8 (range, 3.2-12.9) months for the 240 mg, 400 mg, and 600 mg dose groups, respectively.<\/li>\n<\/ul>
\nThese compelling safety and efficacy findings support the rationale to initiate a global, randomized Phase 3 clinical trial with BGB-43395 in combination with letrozole in 1L HR+\/HER2- metastatic breast cancer. The trial, KANDELA-302 (NCT07492641<\/a>), will begin enrolling patients this month.<\/p>
\nB7-H4 ADC demonstrates encouraging efficacy supporting advancement in ovarian cancer (Rapid Oral Abstract: 3013; June 2, 2026, 9:45-11:15 AM CDT)<\/b>
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- \nAt doses under consideration for future development, confirmed ORR of 45.5% and unconfirmed ORR of 54.5% in ovarian cancer (OC), and 40.0% in triple-negative breast cancer, with median study follow-up of 6.6 (range, 0.3-20.8) months.<\/li>\n
- \nAnti-tumor activity demonstrated in OC regardless of B7-H4 expression level.<\/li>\n
- \nTreatment was generally well tolerated with low rates of discontinuation at <5%; 31.5% of patients experienced Grade \u22653 TRAEs, with no Grade \u22653 nausea at 6 mg\/kg adjusted ideal body weight (AIBW) and 1.2% at 8 mg\/kg AIBW. Grade \u22653 neutropenia rates were 14.8% at 6 mg\/kg AIBW and 34.6% at 8 mg\/kg AIBW.<\/li>\n
- \nAIBW-based dosing used in the ongoing phase 1 study of BG-C9074 effectively reduced pharmacokinetic variability compared with total body weight dosing, as presented in a separate abstract (Poster 166) at ASCO.<\/li>\n<\/ul>
\nThese results support continued advancement of the BG\u2011C9074 development program, with efforts focused on early\u2011line OC and additional B7\u2011H4-expressing tumor types.<\/p>
\nPotential first-in-class GPC3x4-1BB bispecific demonstrates unprecedented anti-tumor activity in heavily pre-treated HCC patients (Rapid Oral Abstract: 3016; June 2, 2026, 9:45-11:15 AM CDT)<\/b>
\nHighlights include:<\/p>
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- \nAt doses \u2265300 mg, confirmed ORR was 28.9% and unconfirmed ORR was 31.6%, with median study follow-up of 4.8 (range, 0.3-15.5) months.<\/li>\n
- \nTreatment was generally well tolerated across all dose levels (1-1000 mg every three weeks [Q3W], N = 61) with no significant dose-dependent increase in rates of treatment-emergent adverse events (TEAEs):\n
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- \n68.9% (42) of patients experienced TEAEs; of these:\n
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- \n47.5% (29) were treatment related<\/li>\n
- \n8.2% (5) of patients experienced Grade \u22653 TRAEs<\/li>\n
- \n4.9% (3) were treatment-related serious adverse events<\/li>\n<\/ul><\/li>\n
- \nTEAE leading to treatment discontinuation occurred in 3.3% (2) of patients<\/li>\n
- \nDose limiting toxicity occurred in 1.6% (1) of patients<\/li>\n<\/ul><\/li>\n
- \nTRAEs that occurred in >5% of patients were limited to increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST), both occurring at Grade \u22653 in only 1.6% of patients.<\/li>\n<\/ul>
- \n68.9% (42) of patients experienced TEAEs; of these:\n
- \nB7-H4 ADC (BG\u2011C9074)<\/b> (rapid oral presentation): Phase 1 dose-escalation and safety expansion data in advanced solid tumors.<\/li>\n