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CORNERSTONE PHARMACEUTICALS (02616.HK): Clinical Data of Tri-Specific Antibody CS2009 Shows Strong Efficacy in Lung Cancer
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CORNERSTONE PHARMACEUTICALS-B (02616.HK) announced the latest clinical progress of its independently developed PD-1/VEGF/CTLA-4 tri-specific antibody CS2009. As of mid-March this year, the Phase I clinical trial has enrolled 113 patients with advanced solid tumors, with a median follow-up of approximately six months. The incidence of treatment-related adverse events of grade 3 or higher was 23%, and no severe toxicity commonly observed in CTLA-4 and PD-(L)1 combination therapies was noted. The incidence of VEGF-related adverse events of grade 3 or higher was low.

Preliminary efficacy data of CS2009 monotherapy for lung cancer in Phase I/II is positive. In first-line non-small cell lung cancer (NSCLC) patients with a PD-L1 tumor cell positive proportion score [TPS] of 50% or higher, the objective response rate (ORR) reached 90%, and the disease control rate (DCR) was 100%. In second-line and later-line NSCLC patients who had undergone immunotherapy (IO) and were negative for actionable genetic alterations (AGA), the ORR was 25%.

CORNERSTONE PHARMACEUTICALS plans to initiate the first batch of Phase III global multi-center clinical trials for CS2009 by the end of 2026, focusing on indications such as non-small cell lung cancer, colorectal cancer, and small cell lung cancer. More Phase I and II clinical research data is expected to be released at the American Society of Clinical Oncology Annual Meeting and the European Society for Medical Oncology Annual Meeting in 2026. (ec/u)
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