China-based CStone Pharmaceuticals (HKG: 2616) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sugemalimab, in combination with platinum-based chemotherapy, as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This follows an authorization by the European Commission in July of this year.
The approval is primarily supported by data from the GEMSTONE-302 trial, a multicenter, randomized, double-blind phase III study. The trial demonstrated that sugemalimab combined with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to a placebo combined with chemotherapy in treatment-naïve patients with metastatic NSCLC.
Sugemalimab, an anti-PD-L1 monoclonal antibody, was developed by CStone using the OmniRat transgenic animal platform licensed from US firm Ligand. In May of this year, CStone entered into a partnership with European firm Ewopharma for the commercialization of sugemalimab in Central & Eastern Europe and Switzerland.- Flcube.com
