CStone Pharmaceuticals Monday has submitted a Type II variation application to the European Medicines Agency - EMA for sugemalimab, seeking approval for treating unresectable stage III non-small cell lung cancer - NSCLC in patients who have not progressed after platinum-based chemoradiotherapy.
If approved, sugemalimab would become an alternative in a space where only one PD-L1 antibody is currently authorized in Europe, potentially strengthening its position as a key immunotherapy for lung cancer.
The submission is backed by data from the GEMSTONE-301 Phase III trial, which showed a 36% reduction in disease progression or death, a 56% reduction in the risk of death, and a favorable safety profile. Sugemalimab is already approved in Europe for metastatic NSCLC.
Sugemalimab has multiple approvals in China, including for metastatic NSCLC, unresectable stage III NSCLC, extranodal NK/T-cell lymphoma, and certain gastrointestinal cancers. It has also received European and UK approvals for use with chemotherapy in metastatic NSCLC patients without specific genomic mutations.
For comments and feedback: editorial@rttnews.com