SAN CARLOS, Calif. — BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track Designation for BGB-B2033, its GPC3x4-1BB bispecific antibody for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment.
“The FDA awards Fast Track Designation to therapies that show potential to address an unmet medical need in serious or life-threatening conditions. The FDA’s decision reflects the encouraging profile of BGB-B2033 in advanced hepatocellular carcinoma, where patients continue to face limited treatment options,” said Julie Lepin, Senior Vice President and Chief Regulatory Affairs Officer at BeOne.
BeOne is currently conducting a global, multi-center Phase 1 clinical trial (NCT06427941) to explore the safety and anti-tumor activity of BGB-B2033, both alone and in combination with PD-1 inhibitor TEVIMBRA® (tislelizumab).
About Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC) is the sixth most common cancer worldwide and the fourth leading cause of cancer-related death.1 HCC accounts for 80% of all primary liver cancers, with the number of new cases expected to double between 2022 and 2050.2 The rising burden of HCC is primarily attributed to the high prevalence of the hepatitis B and hepatitis C viruses (HBV/HBC) and lifestyle factors such as obesity, tobacco, and alcohol consumption.3 With approximately 80% of patients diagnosed in advanced stages and five-year survival rates for this patient population lower than 20%, new treatment options are needed beyond currently available systemic therapy.4
About BGB-B2033
BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in HCC5, and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.6 The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity.
About BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of nearly 12,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.
| References |
| 1 Samant H, Amiri HS, Zibari GB. Addressing the worldwide hepatocellular carcinoma: epidemiology, prevention and management. J Gastrointest Oncol. 2021 Jul;12(Suppl 2):S361-S373. doi: 10.21037/jgo.2020.02.08. PMID: 34422400; PMCID: PMC8343080. |
|
2 Chan, Stephen Lam et al The Lancet Commission on addressing the global hepatocellular carcinoma burden: comprehensive strategies from prevention to treatment. . The Lancet, Volume 406, Issue 10504, 731 – 778 |
|
3 Kim DY. Changing etiology and epidemiology of hepatocellular carcinoma: Asia and worldwide. Journal of Liver Cancer 2024;24(1):62-70. DOI: https://doi.org/10.17998/jlc.2024.03.13 |
|
4 Li D, Sedano S, Allen R, Gong J, Cho M, Sharma S. Current Treatment Landscape for Advanced Hepatocellular Carcinoma: Patient Outcomes and the Impact on Quality of Life. Cancers (Basel). 2019 Jun 18;11(6):841. doi: 10.3390/cancers11060841. PMID: 31216701; PMCID: PMC6627588. |
|
5 Fanching Lin et al. Novel GPC3-targeting radiopharmaceutical therapy for hepatocellular carcinoma. J Clin Oncol 42, 525-525(2024).DOI:10.1200/JCO.2024.42.3_suppl.525 |
|
6 Kim DY et al. 4-1BB Delineates Distinct Activation Status of Exhausted Tumor-Infiltrating CD8+ T Cells in Hepatocellular Carcinoma. Hepatology, VOL. 71, NO. 3, 2020. https://onlinelibrary.wiley.com/doi/pdf/10.1002/hep.30881 |
Investor Contact
Liza Heapes
+1 857-302-5663
[email protected]
Media Contact
Kyle Blankenship
+1 667-351-5176
[email protected]