CStone's Sugemalimab Approved for First-Line NSCLC Treatment in UK
Friday, November 01, 2024
CStone Pharmaceuticals has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab.
Sugemalimab is a unique anti-PD-L1 monoclonal antibody developed by CStone using its proprietary OmniRat® technology. It is designed to not only block the PD-1/PD-L1 interaction but also induce antibody-dependent cellular phagocytosis (ADCP), which may lead to enhanced efficacy and safety.
This drug, when combined with platinum-based chemotherapy, is now a first-line treatment option for adult patients with metastatic non-small cell lung cancer (NSCLC) who do not have EGFR-sensitive mutations or ALK, ROS1, or RET genomic alterations.
This is the second international approval for sugemalimab, following its recent authorisation by the European Commission.
The MHRA's approval is based on data from the GEMSTONE-302 trial, which showed that sugemalimab combined with chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared to placebo plus chemotherapy in previously untreated patients with metastatic NSCLC.
CStone is actively pursuing additional partnerships in various regions, including Western Europe, Latin America, the Middle East, Southeast Asia, and Canada.
The company is also working with the European Medicines Agency (EMA) and other regulatory agencies to seek approval for sugemalimab in other indications, such as Stage III NSCLC, first-line gastric cancer, and first-line esophageal squamous cell carcinoma.
Source: cstonepharma.com
