Summary by Moomoo AI
GSK announced on December 16, 2024, that its B7-H3-targeted antibody-drug conjugate (GSK'227) has received Priority Medicines (PRIME) Designation from the European Medicines Agency for treating relapsed extensive-stage small-cell lung cancer (ES-SCLC). This follows the FDA's Breakthrough Therapy Designation granted in August 2024, supporting medicines with potential major therapeutic advantages.The designation is based on preliminary clinical data from the ARTEMIS-001 study, an ongoing phase I trial involving over 200 patients with advanced solid tumours. GSK recently initiated a global phase I trial to support GSK'227's registrational pathway, following its acquisition of exclusive worldwide rights (excluding Greater China) from Hansoh.ES-SCLC represents 60-85% of all SCLC cases at diagnosis, with particularly poor outcomes for platinum-resistant patients showing median survival under six months. In Europe alone, 2022 saw approximately 484,554 new lung cancer cases and 375,784 deaths, with SCLC accounting for 10-15% of all lung cancer cases.
