UK-based pharmaceutical company GSK has received the European Medicines Agency (EMA) Priority Medicines (PRIME) Designation for GSK5764227 (GSK’227).
GSK’227 is a B7-H3-targeted antibody-drug conjugate (ADC) comprising a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload.
Also known as HS-20093, the investigational ADC is currently being evaluated for the treatment of patients with relapsed extensive-stage small-cell lung cancer (ES-SCLC).
Earlier this year, GSK acquired global rights to GSK’227 from Chinese biopharmaceutical company Hansoh Pharma, except in mainland China, Hong Kong, Macau, and Taiwan.
Hansoh is developing the drug for lung cancer, sarcoma, head and neck cancers and other cancers in multiple studies in China.
EMA granted the PRIME Designation based on preliminary clinical data from the ARTEMIS-001, an ongoing open-label, multi-centre Phase 1 study of more than 200 patients.
Conducted by Hansoh, the study evaluated the safety, tolerability, and preliminary anti-tumour activity in locally advanced or metastatic solid tumours, including ES-SCLC.
It is the second regulatory designation for GSK’227, after the US Food and Drug Administration (FDA) Breakthrough Therapy Designation in August this year.
GSK R&D global head oncology senior vice president Hesham Abdullah said: “This PRIME Designation is an important step forward as we seek to accelerate the development of GSK’227 in extensive-stage small-cell lung cancer and other tumour types with limited treatments.
“Our investigational B7-H3-targeted ADC is a key component of our broader ADC programme.”
In a separate development, GSK has secured the US FDA Breakthrough Therapy Designation for Jemperli (dostarlimab) to treat a type of rectal cancer.
Jemperli is indicated for patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer.
FDA granted the Breakthrough Therapy Designation based on data from the ongoing Phase 2 study at Memorial Sloan Kettering Cancer Centre, in collaboration with GSK.
In addition, the British drugmaker secured a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) an expanded approval of Jemperli plus chemotherapy (carboplatin and paclitaxel).
Jemperli plus chemotherapy will be indicated for first-line treatment of all adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
The indication includes patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, who represent 70-75% of patients with endometrial cancer, said GSK.
