GSK'227 Receives EMA PRIME Designation

GSK plc announced that the European Medicines Agency (EMA) has granted its B7-H3-targeted antibody-drug conjugate, GSK5764227 (GSK'227), Priority Medicines (PRIME) Designation for treating patients with relapsed extensive-stage small-cell lung cancer (ES-SCLC). This designation highlights the potential of GSK'227 to offer significant therapeutic benefits for patients. This marks the second major regulatory recognition for GSK'227, following the U.S. FDA’s Breakthrough Therapy Designation in August 2024. 

Hesham Abdullah, Senior Vice President, Global Head of Oncology, R&D, GSK, said in a statement, "This PRIME Designation is an important step forward as we seek to accelerate the development of GSK'227 in extensive-stage small-cell lung cancer and other tumour types with limited treatments. Our investigational B7-H3-targeted ADC is a key component of our broader ADC programme."

The PRIME Designation is based on preliminary clinical data from the ARTEMIS-001 study, an ongoing phase I trial involving over 200 patients. The study evaluates the safety, tolerability, and preliminary anti-tumour activity of GSK'227 in various solid tumours, including relapsed ES-SCLC. The trial results were presented at the 2024 World Conference on Lung Cancer. GSK has recently started a global phase I trial to support regulatory approval for GSK'227 further.

Small-cell lung cancer (SCLC) is a significant cause of cancer-related deaths worldwide, with ES-SCLC representing the most advanced and aggressive form of the disease. It accounts for 60-85% of all SCLC cases, with poor outcomes for patients who are platinum-resistant or refractory, often resulting in survival rates of less than six months. Earlier this year, GSK acquired global rights from Hansoh Pharma to develop and commercialise GSK'227, excluding certain regions.