HS-20093 (GSK'227) Receives FDA and EMA Designations for Osteosarcoma and SCLC
核心洞察
HS-20093/GSK'227 (搜索), a B7-H3 (搜索)-targeted ADC, has been granted FDA Breakthrough Therapy Designation for relapsed or refractory osteosarcoma (搜索) after two prior lines of therapy.
The EMA has granted PRIME designation to HS-20093/GSK'227 (搜索) for relapsed extensive-stage small-cell lung cancer (搜索) (ES-SCLC) based on ARTEMIS-001 study data.
Osteosarcoma (搜索), a rare bone cancer primarily affecting children and young adults, lacks FDA-approved treatments after progression on two prior lines of therapy.
Hansoh Pharma (搜索) and GSK's B7-H3 (搜索)-targeted antibody-drug conjugate (ADC), HS-20093 (GSK'227 (搜索)), has received both FDA Breakthrough Therapy Designation (BTD) and EMA PRIME designation for distinct cancer indications. The FDA granted BTD for relapsed or refractory osteosarcoma (搜索), while the EMA granted PRIME designation for relapsed extensive-stage small-cell lung cancer (搜索) (ES-SCLC).
The FDA's decision was based on data from the ARTEMIS-002 study, a Phase II open-label, randomized, multi-center clinical trial evaluating the efficacy and safety of HS-20093 in patients with relapsed or refractory osteosarcoma (搜索) and other unresectable bone and soft tissue sarcomas. The study enrolled over 60 patients, including 42 with osteosarcoma, and the results were presented at the 2024 American Society for Clinical Oncology Annual Meeting.
Unmet Need in Osteosarcoma
Osteosarcoma (搜索) is the most common primary bone cancer, primarily affecting children and young adults. It accounts for 20-40% of all bone cancers, with an annual incidence of 3.3 patients per million in the US. Approximately 20-30% of patients with localized osteosarcoma and 80% with metastatic osteosarcoma experience relapse or refractory disease. Treatment options are severely limited after first-line chemotherapy, with no clear standard of care. Notably, there are no FDA-approved treatments for patients who have progressed on two prior lines of therapy.
EMA PRIME Designation for SCLC
The EMA's PRIME (Priority Medicines) designation for GSK5764227 (HS-20093) in relapsed ES-SCLC is supported by preliminary clinical data from the ARTEMIS-001 study. This ongoing Phase I open-label, multi-center trial is evaluating the safety, tolerability, and preliminary anti-tumor activity in over 200 patients with locally advanced or metastatic solid tumors, including relapsed or refractory ES-SCLC. Efficacy and safety results from this trial were presented at the 2024 World Conference on Lung Cancer.
About HS-20093
HS-20093 is a novel investigational ADC comprising a fully human anti-B7-H3 (搜索) monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload. Hansoh Pharma (搜索) is developing HS-20093 for the treatment of lung cancer, sarcoma, head and neck cancers, and other solid tumors in multiple Phase I, II, and III clinical trials in China. In December 2023, Hansoh Pharma granted GSK an exclusive global license (excluding Mainland China, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize HS-20093. GSK's global Phase I trial for GSK'227 (搜索) began in August 2024.