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GSK plc (LSE/NYSE:GSK) announced Tuesday that its investigational B7-H3-targeted antibody-drug conjugate, GSK5764227 (GSK’227), has received Orphan Drug Designation from the European Medicines Agency for the treatment of pulmonary neuroendocrine carcinoma, which includes small-cell lung cancer.
According to the company’s statement, the designation was granted based on early clinical data from the phase I ARTEMIS-001 trial, which showed durable responses in patients with extensive stage small-cell lung cancer treated with GSK’227. The company noted that small-cell lung cancer is an aggressive form of disease with limited treatment options and poor outcomes. GSK cited external data estimating that about 250,000 people globally are diagnosed with small-cell lung cancer each year, with approximately 200,000 annual deaths.
GSK’227 is described as a B7-H3-targeted antibody-drug conjugate, consisting of a fully human monoclonal antibody linked to a topoisomerase inhibitor payload. GSK holds exclusive worldwide rights to develop and commercialize GSK’227, except for mainland China, Hong Kong, Macau, and Taiwan, where rights remain with Hansoh Pharma. The company began a global phase III trial for GSK’227 in relapsed extensive stage small-cell lung cancer in August 2025.
This marks the fourth regulatory designation for GSK’227. The compound previously received EMA Priority Medicines (PRIME) designation and two US Food and Drug Administration Breakthrough Therapy Designations for relapsed or refractory extensive stage small-cell lung cancer and relapsed or refractory osteosarcoma.
The information in this article is based on a press release statement filed with the US Securities and Exchange Commission.
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