GSK’s B7-H3 Antibody-Drug Conjugate Gains FDA Breakthrough Therapy Designation for Small-Cell Lung Cancer
The US Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to GSK5764227 an investigational antibody-drug conjugate (ADC) from GSK plc (LSE/NYSE: GSK). This designation is intended to accelerate the development and review of drugs that show potential to improve treatment for serious health conditions, particularly where early clinical evidence indicates significant benefits over existing therapies.
Patients with extensive-stage small-cell lung cancer (ES-SCLC) often face limited treatment options and poor outcomes after chemotherapy. Small-cell lung cancer accounts for around 15% of all lung cancers, with 70% of these cases being classified as extensive-stage, indicating that the disease has spread throughout the lungs or to other areas of the body.
The prognosis for ES-SCLC remains bleak, with a five-year survival rate of about 3%. Following initial treatment, most patients relapse, and the current standard of care offers a median overall survival of only five to six months.
The FDA's Breakthrough Therapy Designation is supported by data from the ongoing ARTEMIS-001 Phase 1 trial, which involves more than 200 patients and assesses the safety, tolerability, and preliminary anti-tumour activity of GSK’227 in patients with relapsed or refractory ES-SCLC and other advanced solid tumours.
GSK5764227, referred to as HS-20093, is an innovative investigational antibody-drug conjugate (ADC) designed to target the B7-H3 protein. It is a fully humanized monoclonal antibody targeting B7-H3, conjugated with a topoisomerase inhibitor (TOPOi) payload. Currently, HS-20093 is being for treating lung cancer, sarcoma, head and neck cancers, and other solid tumours in various Phase I and II trials.
