HS-20093, B7-H3-TARGETED ANTIBODY-DRUG CONJUGATE, RECEIVES US FDA BREAKTHROUGH THERAPY DESIGNATION IN LATE-LINE RELAPSED OR REFRACTORY OSTEOSARCOMA
- HS-20093/GSK’227 receives FDA BTD in late-line relapsed or refractory osteosarcoma based on Hansoh’s promising early data.
- There are no FDA-approved treatments for patients with osteosarcoma who have progressed on two prior lines of therapy.
SHANGHAI, Jan 7, 2025, Hansoh Pharma (03692.HK) announced that its Partner GSK has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for GSK5764227 (GSK’227, also known as HS-20093), the B7-H3-targeted antibody-drug conjugate (“ADC”) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy.
The US FDA’s BTD is supported by data from the ARTEMIS-002 study. This is a phase II, open-label, randomised, multi-centre, clinical trial evaluating the efficacy and safety of HS-20093 in patients with relapsed or refractory osteosarcoma and other unresectable bone and soft tissue sarcomas, conducted by Hansoh Pharma. More than 60 patients were enrolled, including 42 patients with osteosarcoma. Results from ARTEMIS-002 were presented at the 2024 American Society for Clinical Oncology Annual Meeting.
Osteosarcoma mainly affects children and young adults and is the most common primary bone cancer, accounting for 20-40% of all bone cancers.1 It is a rare disease with an annual incidence of 3.3 patients per million in the US, representing less than 1% of all new cancer diagnoses.2,3Approximately 20-30% of patients who present with localised (non-metastatic) osteosarcoma and 80% of those who present with metastatic osteosarcoma experience relapsed or refractory disease.4 Following first-line chemotherapy, treatment options for patients with relapsed or refractory osteosarcoma are severely limited, with no clear standard of care available.5 After patients progress on two prior lines of treatment, options become even more limited, with no approved therapies.
About HS-20093
HS-20093, also known as GSK’227, is a novel investigational B7-H3-targeted ADC composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload. HS-20093 is being developed by Hansoh Pharma for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumours in multiple phase I, II and III clinical trials in China.
On December 20, 2023, Hansoh Pharma entered into a license agreement with GSK, granting GSK an exclusive global license (excluding Chinese mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize HS-20093. GSK’s global phase I trial for GSK’227 began in August 2024.
References
1.Valery PC, Laversanne M, Bray F. Bone cancer incidence by morphological subtype: a global assessment. Cancer Causes Control. 2015;26(8):1127-39.
2.Cole S, Gianferante DM, Zhu B, et al. Osteosarcoma: A surveillance, epidemiology, and end results program-based analysis from 1975 to 2017. Cancer. 2022;128(11):2107-18.
3.Mirabello L, Troisi RJ, Savage SA. International osteosarcoma incidence patterns in children and adolescents, middle ages and elderly persons. Int J Cancer. 2009;125(1):229-34.
4.Durfee RA, Mohammed M, Luu HH. Review of Osteosarcoma and Current Management. Rheumatol Ther. 2016 Dec;3(2):221-243. doi: 10.1007/s40744-016-0046-y. Epub 2016 Oct 19. PMID: 27761754; PMCID: PMC5127970.
5.National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology (NCCN Guidelines): bone cancer. August 20, 2024. Version 1.2025. Accessed 24 October 2024. //www.nccn.org/professionals/physician_gls/pdf/bone.pdf
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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