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Date : 01/07/2025

Company Name : GSK plc

Headquarter : United Kingdom

𝐆𝐒𝐊’𝐬 𝐁𝟕-𝐇𝟑-𝐭𝐚𝐫𝐠𝐞𝐭𝐞𝐝 𝐚𝐧𝐭𝐢𝐛𝐨𝐝𝐲-𝐝𝐫𝐮𝐠 𝐜𝐨𝐧𝐣𝐮𝐠𝐚𝐭𝐞, 𝐆𝐒𝐊’𝟐𝟐𝟕, 𝐫𝐞𝐜𝐞𝐢𝐯𝐞𝐬 𝐔𝐒 𝐅𝐃𝐀 𝐁𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐃𝐞𝐬𝐢𝐠𝐧𝐚𝐭𝐢𝐨𝐧 𝐢𝐧 𝐥𝐚𝐭𝐞-𝐥𝐢𝐧𝐞 𝐫𝐞𝐥𝐚𝐩𝐬𝐞𝐝 𝐨𝐫 𝐫𝐞𝐟𝐫𝐚𝐜𝐭𝐨𝐫𝐲 𝐨𝐬𝐭𝐞𝐨𝐬𝐚𝐫𝐜𝐨𝐦𝐚

𝐆𝐒𝐊’𝐬 𝐁𝟕-𝐇𝟑-𝐭𝐚𝐫𝐠𝐞𝐭𝐞𝐝 𝐚𝐧𝐭𝐢𝐛𝐨𝐝𝐲-𝐝𝐫𝐮𝐠 𝐜𝐨𝐧𝐣𝐮𝐠𝐚𝐭𝐞, 𝐆𝐒𝐊’𝟐𝟐𝟕, 𝐫𝐞𝐜𝐞𝐢𝐯𝐞𝐬 𝐔𝐒 𝐅𝐃𝐀 𝐁𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐃𝐞𝐬𝐢𝐠𝐧𝐚𝐭𝐢𝐨𝐧 𝐢𝐧 𝐥𝐚𝐭𝐞-𝐥𝐢𝐧𝐞 𝐫𝐞𝐥𝐚𝐩𝐬𝐞𝐝 𝐨𝐫 𝐫𝐞𝐟𝐫𝐚𝐜𝐭𝐨𝐫𝐲 𝐨𝐬𝐭𝐞𝐨𝐬𝐚𝐫𝐜𝐨𝐦𝐚


- π‘…π‘’π‘”π‘’π‘™π‘Žπ‘‘π‘œπ‘Ÿπ‘¦ π‘‘π‘’π‘ π‘–π‘”π‘›π‘Žπ‘‘π‘–π‘œπ‘› π‘π‘Žπ‘ π‘’π‘‘ π‘œπ‘› π‘π‘Ÿπ‘œπ‘šπ‘–π‘ π‘–π‘›π‘” π‘’π‘Žπ‘Ÿπ‘™π‘¦ π‘‘π‘Žπ‘‘π‘Ž 𝑖𝑛 π‘‘β„Žπ‘–π‘  π‘Ÿπ‘Žπ‘Ÿπ‘’ π‘π‘œπ‘›π‘’ π‘π‘Žπ‘›π‘π‘’π‘Ÿ

- π΅π‘Ÿπ‘’π‘Žπ‘˜π‘‘β„Žπ‘Ÿπ‘œπ‘’π‘”β„Ž π‘‡β„Žπ‘’π‘Ÿπ‘Žπ‘π‘¦ π·π‘’π‘ π‘–π‘”π‘›π‘Žπ‘‘π‘–π‘œπ‘› π‘”π‘Ÿπ‘Žπ‘›π‘‘π‘’π‘‘ π‘‘π‘œ π‘‘π‘Ÿπ‘’π‘”π‘  π‘€π‘–π‘‘β„Ž π‘π‘œπ‘‘π‘’π‘›π‘‘π‘–π‘Žπ‘™ π‘‘π‘œ π‘ β„Žπ‘œπ‘€ π‘–π‘šπ‘π‘Ÿπ‘œπ‘£π‘’π‘šπ‘’π‘›π‘‘ π‘“π‘œπ‘Ÿ π‘ π‘’π‘Ÿπ‘–π‘œπ‘’π‘  π‘π‘œπ‘›π‘‘π‘–π‘‘π‘–π‘œπ‘›π‘ 

- π‘‡β„Žπ‘’π‘Ÿπ‘’ π‘Žπ‘Ÿπ‘’ π‘›π‘œ 𝐹𝐷𝐴-π‘Žπ‘π‘π‘Ÿπ‘œπ‘£π‘’π‘‘ π‘‘π‘Ÿπ‘’π‘Žπ‘‘π‘šπ‘’π‘›π‘‘π‘  π‘“π‘œπ‘Ÿ π‘π‘Žπ‘‘π‘–π‘’π‘›π‘‘π‘  π‘€π‘–π‘‘β„Ž π‘œπ‘ π‘‘π‘’π‘œπ‘ π‘Žπ‘Ÿπ‘π‘œπ‘šπ‘Ž π‘€β„Žπ‘œ β„Žπ‘Žπ‘£π‘’ π‘π‘Ÿπ‘œπ‘”π‘Ÿπ‘’π‘ π‘ π‘’π‘‘ π‘œπ‘› π‘‘π‘€π‘œ π‘π‘Ÿπ‘–π‘œπ‘Ÿ 𝑙𝑖𝑛𝑒𝑠 π‘œπ‘“ π‘‘β„Žπ‘’π‘Ÿπ‘Žπ‘π‘¦

GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), its 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 Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy.1 This is the third regulatory designation for GSK’227, following the European Medicines Agency’s decision to grant Priority Medicines (PRIME) designation and the FDA’s decision to grant Breakthrough Therapy Designation for relapsed or refractory extensive-stage small-cell lung cancer in August 2024 and December 2024, respectively.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: β€œThis latest regulatory designation for GSK’227 exemplifies the potential of our targeted ADC in patients with difficult to treat cancers. For patients with relapsed or refractory osteosarcoma, there is an urgent unmet medical need with no approved treatment options once the cancer returns a second time, and chemotherapy provides limited benefit in this setting.”

The US FDA’s Breakthrough Therapy Designation 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 GSK’227 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 of Clinical Oncology Annual Meeting.4 Last year, GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of GSK’227. GSK recently began a global phase I trial (NCT06551142) as a part of the development plan to support a registrational pathway for GSK’227.

Osteosarcoma mainly affects children and young adults and is the most common primary bone cancer, accounting for 20-40% of all bone cancers.5 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.6,7 Approximately 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.8 Following first-line chemotherapy, treatment options for patients with relapsed or refractory osteosarcoma are severely limited, with no clear standard of care available.9 After patients progress on two prior lines of treatment, options become even more limited, with no approved therapies.

About GSK’227
GSK’227, also known as HS-20093, is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor 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. GSK’s global phase I trial for GSK’227 began in August 2024.