CStone's sugemalimab gets positive CHMP opinion for lung cancer treatment

CStone Pharmaceuticals announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for sugemalimab. This recommendation is for its approval as a monotherapy for adults with unresectable stage III non-small cell lung cancer (NSCLC) exhibiting PD-L1 expression on at least 1% of tumor cells, without sensitizing EGFR mutations, ALK, or ROS1 genomic aberrations, and whose disease has not progressed after platinum-based chemoradiotherapy (CRT).

This marks sugemalimab’s second positive opinion and recommendation from CHMP. The recommendation is based on compelling results from the GEMSTONE-301 study, a Phase III clinical trial that demonstrated dual benefits in progression-free survival and overall survival for stage III NSCLC patients. If approved, sugemalimab will be the second PD-(L)1 antibody available in Europe for this indication.

The National Medical Products Administration (NMPA) of China has already approved sugemalimab for five indications, including in combination with chemotherapy for metastatic squamous and non-squamous NSCLC, and for unresectable stage III NSCLC following chemoradiotherapy. CStone aims to expedite commercialization across European markets with its partners.