LONDON - GSK plc (LSE/NYSE: GSK) has announced that its investigational drug, GSK'227, received the Priority Medicines (PRIME) Designation from the European Medicines Agency (EMA) for the treatment of relapsed extensive-stage small-cell lung cancer (ES-SCLC). The PRIME Designation is given to drugs that show potential to benefit patients with unmet medical needs significantly. This follows the US Food and Drug Administration's Breakthrough Therapy Designation for GSK'227 in August 2024.
The decision by the EMA is based on preliminary clinical data from the ARTEMIS-001 study, an ongoing phase I trial evaluating the safety, tolerability, and anti-tumour activity in over 200 patients with advanced or metastatic solid tumours, including ES-SCLC. The results of this study were presented earlier in the year at the 2024 World Conference on Lung Cancer. GSK has started a global phase I trial to support a registration pathway for the drug.
Lung cancer remains a significant health issue globally, with an estimated 484,554 new cases and 375,784 deaths in Europe in 2022 alone. ES-SCLC, which makes up 60% to 85% of all SCLC cases at diagnosis, is particularly aggressive, with a median overall survival of less than six months for patients resistant or refractory to platinum-based chemotherapy.
GSK'227, also known as HS-20093, is a novel B7-H3-targeted antibody-drug conjugate (ADC) that combines a fully human anti-B7-H3 monoclonal antibody with a topoisomerase inhibitor payload. The drug is being developed by Hansoh Pharma for various cancers, including lung cancer, sarcoma, head and neck cancers, and other solid tumours.
GSK's focus in oncology is on haematologic malignancies, gynaecologic cancers, and solid tumours, with an emphasis on immuno-oncology and tumour-cell targeting therapies. Earlier this year, GSK secured exclusive worldwide rights to progress the clinical development and commercialization of GSK'227, excluding mainland China, Hong Kong, Macau, and Taiwan.
The information about GSK'227's PRIME Designation is based on a press release statement from GSK plc.
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