GSK’s B7-H3-Targeted ADC Receives FDA Breakthrough Therapy for Osteosarcoma Treatment
Tuesday, January 07, 2025
GSK has announced that its investigational antibody-drug conjugate (ADC), GSK5764227 (GSK’227), has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA).
Osteosarcoma, a rare form of primary bone cancer, primarily affects children and young adults. It accounts for 20–40% of all bone cancers and has an annual incidence of approximately 3.3 cases per million in the United States.
Most patients with localised osteosarcoma and the majority of those with metastatic disease experience recurrence. Treatment options following initial chemotherapy are extremely limited, and no standard of care exists for those with relapsed or refractory disease after two lines of treatment.
GSK’227, also known as HS-20093, is an experimental B7-H3-targeted ADC that combines a monoclonal antibody with a topoisomerase inhibitor payload.
It is being developed for various solid tumours, including sarcoma, lung, and head and neck cancers, through multiple clinical trials in China. GSK is conducting global studies to support its broader development and approval.
This designation covers its use in adult patients with relapsed or refractory osteosarcoma who have not responded to at least two previous lines of treatment.
The Breakthrough Therapy Designation is designed to accelerate the development and review of therapies for serious conditions where initial clinical evidence indicates a substantial improvement over existing treatments.
GSK’227 has already received regulatory recognition from the European Medicines Agency, which granted it Priority Medicines (PRIME) designation, and from the FDA for another indication in small-cell lung cancer in 2024.
The FDA’s decision is supported by findings from the ARTEMIS-002 trial, a phase II open-label, randomised, multi-centre study evaluating the ADC’s safety and effectiveness in treating relapsed or refractory osteosarcoma and other sarcomas.
Conducted by Hansoh Pharma, the trial involved over 60 patients, including 42 with osteosarcoma. Data from this study were shared at the 2024 American Society of Clinical Oncology Annual Meeting.
GSK secured global rights (excluding certain regions in Asia) to further develop and commercialise GSK’227 following an agreement with Hansoh Pharma in 2023.
The company has since initiated a global phase I trial as part of the clinical development plan to advance towards regulatory approval.
Source: gsk.com
