GSK’s B7-H3-targeted antibody-drug conjugate, GSK5764227 (GSK’227), received Breakthrough Therapy Designation from the US FDA for treating relapsed or refractory osteosarcoma in adults who have progressed on at least two prior therapies

GSK’227 previously received regulatory designations from both the European Medicines Agency (PRIME designation) and the US FDA for relapsed or refractory extensive-stage small-cell lung cancer

The FDA’s decision for Breakthrough Therapy Designation is supported by data from the ARTEMIS-002 Phase 2 clinical trial, which enrolled over 60 patients, including 42 with osteosarcoma, and demonstrated promising results

GSK acquired exclusive worldwide rights (excluding specific regions in China) from Hansoh Pharma to advance the clinical development and commercialization of GSK’227 and recently initiated a global Phase 1 trial to support its regulatory pathway

Currently, there are no FDA-approved treatments for osteosarcoma patients who have failed two previous therapies.