European Commission Approves Sugemalimab as First-Line Treatment for Metastatic NSCLC

The European Commission (EC) has approved sugemalimab (Cejemly) in combination with platinum-based chemotherapy as a first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitizing EGFR mutations or ALK, ROS1, or RET genomic tumor aberrations, according to an announcement from CStone Pharmaceuticals.

The approval makes sugemalimab “the first anti–PD-L1 monoclonal antibody [mAb] approved in Europe in combination with chemotherapy as first-line treatment for both squamous and nonsquamous NSCLC, making CStone the first innovative biopharmaceutical company to successfully bring a [Chinese] domestic anti–PD-L1 mAb to the international market,” officials said in the announcement.

The EC approval is primarily based on the results from GEMSTONE-302, a multicenter, randomized, double-blind phase 3 study that showed sugemalimab plus chemotherapy significantly prolonged progression-free survival and overall survival compared with placebo combined with chemotherapy in treatment-naïve patients with metastatic NSCLC, according to the announcement.

Results from GEMSTONE-302 have been published in The Lancet Oncology and Nature Cancer. Long-term treatment and survival data from the study will be presented in a poster session at the 2024 European Society for Medical Oncology Annual Meeting in September.

CStone officials said that the company is “actively preparing” to submit multiple Marketing Authorization Applications for additional indications, including stage III NSCLC.

Source: PR Newswire