GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to GSK5764227 (GSK’227), an investigational B7-H3-targeted antibody-drug conjugate (ADC) being studied for the treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy. This designation is intended to accelerate the development and review of drugs that show promise in treating serious conditions and have the potential to offer substantial improvements over existing therapies.
Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, commented, “Extensive-stage small-cell lung cancer is highly aggressive, with a poor prognosis and a significant need for new treatments. The Breakthrough Therapy Designation supports our goal to fast-track GSK’227 for these patients, as part of our broader ADC program focused on pioneering new treatment options with the potential for transformative impact.”
Lung cancer is one of the most prevalent cancers globally, with small-cell lung cancer (SCLC) accounting for about 15% of cases in the US. Among SCLC patients, 70% have extensive-stage disease, meaning the cancer has spread to other parts of the body or throughout one or both lungs. ES-SCLC is notably aggressive and challenging to treat, with limited options available. The 5-year survival rate for ES-SCLC is around 3%, and most patients experience relapse after initial treatment. The median overall survival with current standard treatments for relapsed ES-SCLC is 5-6 months.
Earlier this year, GSK secured exclusive worldwide rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance the clinical development and commercialization of GSK’227. The FDA’s Breakthrough Therapy Designation is supported by data from the ongoing ARTEMIS-001 Phase 1 trial, which involves over 200 patients and evaluates the safety, tolerability, and preliminary anti-tumor activity of GSK’227 in locally advanced or metastatic solid tumors, including relapsed or refractory ES-SCLC. Results from this trial will be presented at the 2024 World Conference on Lung Cancer, scheduled for September 7-10 in San Diego, California. GSK plans to initiate global Phase 1/2 trials in the second half of 2024 to support regulatory approval for GSK’227.
