CStone Submits Application to the European Medicines Agency for New Indication of Sugemalimab in Stage III Non-Small Cell Lung Cancer

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[{"type":"text","content":"SUZHOU, China, March 23, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab. The application seeks approval for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy (CRT). This marks CStone's second regulatory submission for sugemalimab to the EMA, following its initial approval in Europe for metastatic squamous and non-squamous NSCLC in 2024. If this new indication is approved, sugemalimab would address a critical unmet need in stage III NSCLC, where only one PD-L1 antibody is currently approved in Europe. The drug's dual utility in stage III and IV NSCLC could solidify its role as a cornerstone immunotherapy in lung cancer.","length":1023,"tagName":"p"},{"type":"text","content":"The submission is supported by data from the GEMSTONE-301 Phase III trial, a multicenter, randomized, double-blind study evaluating sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC post-CRT. Results published in The Lancet Oncology demonstrated:","length":294,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"36% reduction in risk of disease progression or death, significantly improved progression-free survival (PFS).","length":110,"tagName":"p"}]},{"val":[{"type":"text","content":"56% reduction in risk of death, with a strong positive trend toward overall survival (OS) benefit.","length":98,"tagName":"p"}]},{"val":[{"type":"text","content":"Consistent clinical benefits across subgroups, regardless of prior CRT modality (concurrent or sequential).","length":107,"tagName":"p"}]},{"val":[{"type":"text","content":"Favorable safety profile, no new safety signals identified.","length":59,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":374,"olType":false},{"type":"text","content":"Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented: "Following sugemalimab's approval in Europe for stage IV NSCLC, we are working closely with EMA to expand its ind...

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