Cecilia Brown

DocwireNews

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 &ldquo;the first anti&ndash;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&ndash;PD-L1 mAb to the international market,&rdquo; 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-na&iuml;ve 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 &ldquo;actively preparing&rdquo; to submit multiple Marketing Authorization Applications for additional indications, including stage III NSCLC.Source: <a href="https://www.prnewswire.com/news-releases/cstone-announces-european-commission-approval-of-sugemalimab-cejemly-as-first-line-treatment-for-non-small-cell-lung-cancer-302207524.html">PR Newswire</a>

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

Non-Small Cell Lung Cancer

The European Commission (EC) has approved sugemalimab (Cejemly) in combination with platinum-based chemotherapy as a first-line treatment of adults with metastatic NSCLC.

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