GSK Granted Breakthrough Therapy Designation by FDA for New Lung Cancer Treatment
Wednesday, August 21, 2024
GSK announced today that the US Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to GSK5764227 (GSK'227), an investigational antibody-drug conjugate (ADC) targeting B7-H3.
GSK5764227, also known as HS-20093, is an investigational ADC targeting B7-H3. It consists of a fully humanised anti-B7-H3 monoclonal antibody linked to a topoisomerase inhibitor (TOPOi) payload.
HS-20093 is being developed by Hansoh Pharma for treating lung cancer, sarcoma, head and neck cancers, and other solid tumours in various Phase 1 and 2 trials in China. GSK’s global Phase 1 trials for GSK5764227 are scheduled to begin in the second half of 2024.
ES-SCLC is a challenging cancer to treat, with a 5-year survival rate of approximately 3%. Most patients relapse following initial treatment, and the current standard-of-care for relapsed ES-SCLC offers a median overall survival of just 5-6 months.
Lung cancer remains one of the most prevalent cancers globally. In the United States, around 15% of lung cancer cases are classified as small-cell lung cancer (SCLC), with 70% of these being at an extensive stage where the cancer has spread to other parts of the body.
This treatment is being explored for patients with extensive-stage small-cell lung cancer (ES-SCLC) who have experienced disease progression after platinum-based chemotherapy.
Breakthrough Therapy Designation is intended to speed up the development and review of medicines that show potential in treating serious conditions, especially where early clinical data suggests a significant improvement over existing treatments.
Extensive-stage small-cell lung cancer is a particularly aggressive disease with a poor prognosis, making the need for new treatments urgent. This designation aligns with our goal of accelerating the development of GSK'227 as part of our broader programme focused on creating new treatment options with the potential to transform patient outcomes.
Earlier this year, GSK acquired exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance the clinical development and commercialisation of GSK'227.
The FDA's Breakthrough Therapy Designation is based on data from the ongoing ARTEMIS-001 Phase 1 trial conducted by Hansoh Pharma, which is assessing the safety, tolerability, and preliminary anti-tumour activity of GSK'227 in over 200 patients with locally advanced or metastatic solid tumours, including relapsed or refractory ES-SCLC.
Findings from this study will be presented at the 2024 World Conference on Lung Cancer in September in San Diego, California. GSK plans to commence global Phase 1/2 trials in the second half of 2024 to support the potential registration of GSK'227.
Source:gsk.com
