GSK plc has revealed that the European Medicines Agency (EMA) has awarded Priority Medicines (PRIME) status to GSK5764227 (GSK’227), a B7-H3-aimed antibody-drug conjugate (ADC) undergoing trials for patients with recurrent extensive-stage small-cell lung cancer (ES-SCLC). The PRIME Designation facilitates the progression of pharmaceutical solutions with the potential to offer significant therapeutic benefits.
This recognition follows another regulatory milestone for GSK’227, with the US FDA bestowing Breakthrough Therapy Designation in August 2024.
Hesham Abdullah, senior vice president and global head of oncology R&D at GSK, commented: “Receiving the PRIME Designation marks a crucial advancement as we endeаvour to expedite the development of GSK’227 in both extensive-stage small-cell lung cancer and other types of tumоrs with few available treatments. Our investigational ADC that targets B7-H3 is vital to our expansive ADC program.”
The PRIME Designation from the EMA is bolstered by early clinical data from the ARTEMIS-001 study, a phase I open-label, multi-center trial with over 200 participants. It assesses safety, tolerability, and preliminary anti-tumour response in locally advanced or metastatic solid tumours, including recurrent ES-SCLC. This study, led by Hansoh Pharma, had its findings on safety and efficacy presented at the 2024 World Conference on Lung Cancer. GSK has recently commenced a global phase I trial to support GSK’227’s approval path.
Lung cancer remains a predominant cause of cancer-related morbidity and mortality worldwide. In 2022, Europe saw approximately 484,554 new instances and 375,784 deaths due to lung cancer. Small-cell lung cancer (SCLC) accounts for 10-15% of all lung cancer cases and ranks highly in lethality. ES-SCLC cases, comprising 60% to 85% of all SCLC diagnoses, are characterized by tumours spreading beyond the lungs. For patients resistant to or untreated by platinum, the prognosis is dismal, with median survival less than six months.
Earlier this year, GSK secured exclusive international rights (besides mainland China, Hong Kong, Macau, and Taiwan) from Hansoh to advance the clinical development and commercialization of GSK’227.
Also referred to as HS-20093, GSK’227 represents a novel exploratory ADC that targets B7-H3, comprising a fully human anti-B7-H3 monoclonal antibody bound to a topoisomerase inhibitor (TOPOi) payload. Developed by Hansoh Pharma, HS-20093 is targeted for lung cancer, sarcoma, head and neck cancers, and other solid tumours across multiple phase I, II, and III trials in China. GSK’s own global phase I trial for GSK’227 began in August 2024.
GSK views oncology as a rising therapeutic domain, committed to enhancing patient survival. The current focus includes hematologic malignancies, gynecologic cancers, and other solid tumours, utilizing advancements in immuno-oncology and tumour cell-targeted therapies.