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Kelun-Biotech Announces Phase III Trial of Sac-TMT in Combination with KEYTRUDA® (pembrolizumab) as First-Line Treatment for PD-L1-Positive NSCLC Met Primary Endpoint
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) announced today that the Independent Data Monitoring Committee (IDMC) concluded that the Phase III clinical study (OptiTROP-Lung05) of the company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870), in combination with MSD's anti-PD-1 therapy KEYTRUDA®[1] (pembrolizumab), as a first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC), has demonstrated a statistically sign
About this update from Sichuan Kelun-biotech Biopharmaceutical Co., Ltd. Class H
[{"type":"text","content":"CHENGDU, China, Nov. 24, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) announced today that the Independent Data Monitoring Committee (IDMC) concluded that the Phase III clinical study (OptiTROP-Lung05) of the company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870), in combination with MSD's anti-PD-1 therapy KEYTRUDA®[1] (pembrolizumab), as a first-line treatment for PD-L1-positive advanced non-small cell lung cancer (NSCLC), has demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the study's primary endpoint. A positive trend in overall survival was also observed. This is the first Phase III clinical trial of ADC combined with immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC.","length":907,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/四川科倫博泰生物醫藥股份有限公司)","displaySize":"","headline":null,"caption":"(PRNewsfoto/四川科倫博泰生物醫藥股份有限公司)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":116,"url":"https://media.zenfs.com/en/prnewswire.com/5455aad5e4ea0b08ff580f6c7e429747"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/vx69Ffpvj_nbbyPMBYckiw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIwNDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/5455aad5e4ea0b08ff580f6c7e429747","width":400,"height":116}},"href":"https://mma.prnewswire.com/media/2650617/logo_kelun_Biotech_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"OptiTROP-Lung05 is a randomized, open-label, multicenter Phase III clinical study evaluating the efficacy and safety profile of sac-TMT in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment of patients with PD-L1-positive locally advanced or metastatic NSCLC with PD-L1 TPS ≥ 1%. At a pre-specified interim analysis, the sac-TMT combination therapy demonstrated a statistically significant and clinically meaningful improvement in PFS. Based on the results from the interim analysis, the Company plans to communicate with the Center for Drug Evaluation (CDE) of th...
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