{"id":48641,"date":"2026-10-24T10:15:00","date_gmt":"2026-10-24T10:15:00","guid":{"rendered":"http:\/\/www.prnasia.com\/story\/archive\/5079685_AE79685_0"},"modified":"2026-10-24T10:15:00","modified_gmt":"2026-10-24T10:15:00","slug":"phase-ii-results-of-sacituzumab-tirumotecan-sac-tmt-plus-pembrolizumab-in-advanced-urothelial-carcinoma-presented-at-2026-esmo","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=48641","title":{"rendered":"Phase II Results of Sacituzumab Tirumotecan (sac-TMT) plus Pembrolizumab in Advanced Urothelial Carcinoma Presented at 2026 ESMO"},"content":{"rendered":"<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mmx.prnasia.com\/media\/MS1883382\/20260715041831EDT_image_1.jpg?id=OA3037743&amp;p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\">CHENGDU, China<\/span>, <span class=\"legendSpanClass\">Oct. 24, 2026<\/span> \/PRNewswire\/ &#8212; Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (&#8220;Kelun-Biotech&#8221; or the &#8220;Company&#8221;, 6990.HK) announced that at the 2026 European Society for Medical Oncology (ESMO) Congress held in Madrid, updated results from the Phase II MK-2870-002\/SKB264-II-06 study of sacituzumab tirumotecan (sac-TMT, also known as SKB264\/MK-2870)(\u4f73\u6cf0\u83b1<sup>\u00ae<\/sup>) plus MSD&#8217;s<sup>[1]<\/sup> anti-programmed cell death protein 1 (PD-1) monoclonal antibody pembrolizumab (KEYTRUDA<sup>\u00ae<\/sup><sup>[2]<\/sup>) in locally advanced or metastatic urothelial carcinoma (la\/mUC) were presented as a rapid oral report by Professor Xiaojie Bian from Fudan University Shanghai Cancer Center (4739RO; Rapid oral | Genitourinary Tumours, Renal and Urothelial).<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p> <a href=\"https:\/\/mmx.prnasia.com\/media\/MS2019512\/20261023043036EDT_image_1.jpg?id=OA3037741&amp;p=medium600\" target=\"_blank\"><img decoding=\"async\" src=\"https:\/\/mmx.prnasia.com\/media\/MS2019512\/20261023043036EDT_image_1.jpg?id=OA3037741&amp;p=medium600\" title alt><\/a><br \/><span><\/span><\/p>\n<\/p><\/div>\n<p>This is an international, multicenter, open-label, multi-cohort Phase II basket trial. Cohort B enrolled a total of 40 patients with la\/mUC who had not previously received systemic therapy and were cisplatin-ineligible; patients received sac-TMT 4 mg\/kg or 5 mg\/kg in combination with pembrolizumab.<\/p>\n<p>As of January 26, 2026, with a median follow-up of 22.8 months, the efficacy data showed:<\/p>\n<ul type=\"disc\">\n<li>Confirmed objective response rate (ORR) was 68%, and confirmed disease control rate (DCR) was 88%; median duration of response (DOR) was 19.4 months; responses were observed irrespective of trophoblast cell-surface antigen 2 (TROP2) and programmed cell death ligand 1 (PD-L1) expression.<\/li>\n<li>Median progression-free survival (PFS) was 11.2 months (95% CI: 5.8-not reached (NR)); median overall survival (OS) was NR (95% CI: 17.2-NR).<\/li>\n<\/ul>\n<p>In terms of safety, 63% of patients experienced grade \u22653 treatment-related adverse events (TRAEs), most commonly anemia, decreased neutrophil count and stomatitis. Only a small number of patients developed ocular surface toxicity (all were grade \u22642), and no patients experienced interstitial lung disease\/pneumonitis. The incidence of TRAEs leading to permanent discontinuation of sac-TMT was 8%, and no fatal TRAEs occurred.<\/p>\n<p>The study showed that sac-TMT plus pembrolizumab demonstrated promising antitumor activity in cisplatin-ineligible patients with previously untreated la\/mUC, regardless of TROP2 and PD-L1 expression levels. The combination regimen had a manageable safety profile, consistent with the known safety profiles of each monotherapy. These data support the initiation of global Phase III TroFuse-055 study (NCT07829783).<\/p>\n<p>Professor Xiaojie Bian from Fudan University Shanghai Cancer Center said: &#8220;Sac-TMT, a TROP2-targeting ADC, combined with pembrolizumab as an ADC+IO regimen, has demonstrated encouraging efficacy in first-line cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma, with a favorable safety profile for long-term dosing. We look forward to further exploration in subsequent studies.&#8221;<\/p>\n<p><b><u>About sac-TMT(<\/u><\/b><b><u>\u4f73\u6cf0\u83b1<\/u><\/b><b><u><sup>\u00ae<\/sup><\/u><\/b><b><u>)<\/u><\/b><\/p>\n<p>Sac-TMT, a core product of the Company, is a novel TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload (KL610023) in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023 induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.<\/p>\n<p>In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck &amp; Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).<\/p>\n<p>To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)\/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+\/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China&#8217;s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations by the NMPA.<\/p>\n<p>Sac-TMT is the world&#8217;s first TROP2 ADC drug approved for marketing in lung cancer. Two new indication applications have been accepted for review by the NMPA: 1) sac-TMT in combination with pembrolizumab as first\u2011line treatment for locally advanced or metastatic NSCLC who have PD-L1 tumor proportion score (TPS) \u22651% and are EGFR-negative and ALK-negative; 2) sac\u2011TMT as first\u2011line treatment for patients with recurrent or metastatic TNBC who have a PD\u2011L1 combined positive score (CPS) &lt;10 or have recurred after prior PD\u20111\/PD\u2011L1 inhibitor therapy in the early stage, both of the above two applications have been included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 18 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.<\/p>\n<p><b><u>About Kelun-Biotech<\/u><\/b><\/p>\n<p>Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&amp;D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of the world.&nbsp;Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 2 projects with 3 indications are in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world&#8217;s leading proprietary ADC and novel DC platforms, OptiDC\u2122, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit: <a href=\"https:\/\/en.kelun-biotech.com\/\" target=\"_blank\" rel=\"nofollow\">https:\/\/en.kelun-biotech.com\/<\/a>.&nbsp;<\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody readability=\"7\">\n<tr readability=\"9\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"9\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup>[1]<\/sup> MSD is the tradename of Merck &amp; Co., Inc, Rahway, NJ, USA.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"12\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"11\">\n<p class=\"prnml4\"><span class=\"prnews_span\"><sup>[2]<\/sup> KEYTRUDA<sup>\u00ae <\/sup>(pembrolizumab) is a registered trademark of Merck Sharp &amp; Dohme LLC (MSD), a subsidiary of Merck &amp; Co., Inc., Rahway, NJ, USA.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder2\">\n<p> <a href=\"https:\/\/mmx.prnasia.com\/media\/MS2019513\/20261023043036EDT_image_2.jpg?id=OA3037742&amp;p=medium600\" target=\"_blank\"><img decoding=\"async\" src=\"https:\/\/mmx.prnasia.com\/media\/MS2019513\/20261023043036EDT_image_2.jpg?id=OA3037742&amp;p=medium600\" title alt><\/a><br \/><span><\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CHENGDU, China, Oct. 24, 2026 \/PRNewswire\/ &#8212; Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (&#8220;Kelun-Biotech&#8221; or the &#8220;Company&#8221;, 6990.HK) announced that at the 2026 European Society for Medical Oncology (ESMO) Congress held in Madrid, updated results from the Phase II MK-2870-002\/SKB264-II-06 study of sacituzumab tirumotecan (sac-TMT, also known as SKB264\/MK-2870)(\u4f73\u6cf0\u83b1\u00ae) plus MSD&#8217;s[1] anti-programmed cell death protein 1 [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":48642,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-48641","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Phase II Results of Sacituzumab Tirumotecan (sac-TMT) plus Pembrolizumab in Advanced Urothelial Carcinoma Presented at 2026 ESMO - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=48641\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Phase II Results of Sacituzumab Tirumotecan (sac-TMT) plus Pembrolizumab in Advanced Urothelial Carcinoma Presented at 2026 ESMO - My Blog\" \/>\n<meta property=\"og:description\" content=\"CHENGDU, China, Oct. 24, 2026 \/PRNewswire\/ &#8212; Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (&#8220;Kelun-Biotech&#8221; or the &#8220;Company&#8221;, 6990.HK) announced that at the 2026 European Society for Medical Oncology (ESMO) Congress held in Madrid, updated results from the Phase II MK-2870-002\/SKB264-II-06 study of sacituzumab tirumotecan (sac-TMT, also known as SKB264\/MK-2870)(\u4f73\u6cf0\u83b1\u00ae) plus MSD&#8217;s[1] anti-programmed cell death protein 1 [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/transmediavictoria.net.au\/?p=48641\" \/>\n<meta property=\"og:site_name\" content=\"My Blog\" \/>\n<meta property=\"article:published_time\" content=\"2026-10-24T10:15:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mmx.prnasia.com\/media\/MS1883382\/20260715041831EDT_image_1.jpg?id=OA3037743&amp;p=medium600\" \/>\n<meta name=\"author\" content=\"admin_tony\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin_tony\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=48641#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=48641\"},\"author\":{\"name\":\"admin_tony\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"headline\":\"Phase II Results of Sacituzumab Tirumotecan (sac-TMT) plus Pembrolizumab in Advanced Urothelial Carcinoma Presented at 2026 ESMO\",\"datePublished\":\"2026-10-24T10:15:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=48641\"},\"wordCount\":1124,\"image\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=48641#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/transmediavictoria.net.au\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/phase-ii-results-of-sacituzumab-tirumotecan-sac-tmt-plus-pembrolizumab-in-advanced-urothelial-carcinoma-presented-at-2026-esmo.jpg\",\"articleSection\":[\"Business News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=48641\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=48641\",\"name\":\"Phase II Results of Sacituzumab Tirumotecan (sac-TMT) plus Pembrolizumab in Advanced Urothelial Carcinoma Presented at 2026 ESMO - 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