GlaxoSmithKline: Promising Advances in Oncology

The British pharmaceutical company GlaxoSmithKline (GSK) has received the coveted PRIME designation from the European Medicines Agency (EMA) for its B7-H3 targeted antibody-drug conjugate GSK'227. This recognition opens up new possibilities for the treatment of recurrent extensive-stage small cell lung cancer (ES-SCLC). Previously, the US FDA granted the drug breakthrough therapy status in August 2024. The EMA's decision is based on promising clinical results from the ARTEMIS-001 study. This ongoing Phase I study examines the safety, tolerability, and initial anti-tumor efficacy of GSK'227 in over 200 patients. The drug is being tested on individuals with locally advanced or metastatic solid tumors, including recurrent ES-SCLC. Hesham Abdullah, global head and Senior Vice President of GSK Oncology Research and Development, emphasized that the PRIME designation represents a significant step in advancing the development of GSK'227. This highlights the central role of the drug in the company's comprehensive ADC program. To support the regulatory path to therapy, GSK has already initiated a global Phase I study. GSK acquired the exclusive global rights to further develop and market the drug, except in certain Asian markets, from Hansoh at the beginning of 2024. GSK'227, also known as HS-20093, is a fully human anti-B7-H3 monoclonal antibody linked to a topoisomerase inhibitor. In addition to the ARTEMIS-001 study, it is currently being investigated in other clinical studies in China for the treatment of various solid tumors, such as lung cancer, sarcomas, and head and neck cancer. Finally, the company also announced progress in the field of vaccines. In November 2024, GSK received approval from the Japanese Ministry of Health to expand the indication of its RSV vaccine Arexvy for vulnerable individuals aged 50 to 59.