Sacituzumab tirumotecan

CHENGDU, China, May 29, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) announced today that at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, the results of the Phase III clinical study OptiTROP-Lung05, evaluating the company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱®) in combination with pembrolizumab (KEYTRUDA®[1], MSD's anti-programmed cell death protein 1 (PD-1) antibody) as first-line treatment for Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS)≥1% non-small cell lung cancer (NSCLC), was presented as an oral presentation by Professor Caicun Zhou from Shanghai East Hospital, Tongji University (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell). (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) (PRNewsfoto/Kelun-Biotech) Sac-TMT is designed with a unique, bifunctional linker and differentiated belotecan-derivative payload. The linker is conjugated via cysteine, which maximizes payload delivery to tumor cells both through its irreversible connection with the high-affinity and targeting anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a moderately toxic novel topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. In the OptiTROP-Lung05 study, a total of 413 patients were randomized (1:1) to receive either sac-TMT in combination with pembrolizumab or pembrolizumab monotherapy. As of the data cutoff date (September 29, 2025), with a median follow‑up of 10.5 months, the study demonstrated that: Progression-free survival (PFS) showed statistically significant and clinically meaningful benefit in sac-TMT plus pembrolizumab compared with pembrolizumab alone. The median PFS assessed by blinded independent central review (BICR) was not reached (NR) vs 5.7 months (HR=0.35; 95% CI: 0.26-0.47; p<0.0001). The 12-month PFS rate was 62.4% vs 29.0%. Consistent benefit across prespecified subgroups: In patients with PD‑L1 TPS ≥50% and TPS 1–49%, the PFS HRs were 0.47 (95% CI: 0.29–0.77) and 0.28 (95% CI: 0.19–0.41), respectively. In patients with non‑squamous and squamous NSCLC, the PFS HRs were 0.28 (95% CI: 0.18–0.43) and 0.44 (95% CI: 0.29–0.66), respectively. Overall survival (OS) was not yet mature but showed a positive trend: median OS was NR vs 14.5 months (HR = 0.55; 95% CI: 0.36–0.85). The 12‑month OS rate was 80.4% vs 68.9%. The combination group showed improvements over pembrolizumab monotherapy group in objective response rate (ORR) (70.2% vs 42.0%), deep response rate (49.0% vs 25.9%), and 12-month duration of response rate (77.7% vs 59.4%). The incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was higher in the combination group, primarily driven by the expected hematologic adverse events of sac-TMT. Incidence of discontinuation of pembrolizumab due to TEAEs was similar in both groups. No sac-TMT-related deaths occurred. Adverse events of special interest (AEOSIs) were consistent with the known safety profiles of each individual agent, and no new safety signals were identified. The interim analysis results show that sac-TMT plus pembrolizumab significantly prolonged PFS and reduced the risk of disease progression or death compared with pembrolizumab alone, with consistent PFS benefits observed across all prespecified subgroups (including PD‑L1 expression levels and histological subtypes). A positive trend in OS was also observed. Furthermore, the overall safety profile of sac-TMT in combination with pembrolizumab was manageable, consistent with the established safety profiles of sac-TMT alone or pembrolizumab alone. Notably, the findings of OptiTROP-Lung05 have been simultaneously published in The Lancet（Impact Factor=88.5）, indicating that its clinical and academic value has received dual recognition from a leading international academic conference and an authoritative journal. Professor Caicun Zhou, the national leading principal investigator from Shanghai East Hospital, Tongji University, said: "The positive results of the OptiTROP‑Lung05 study are encouraging. The study not only supports the application of sac‑TMT in an earlier-line setting for lung cancer, but also provides evidence of the 'ADC+IO' synergistic strategy being evaluated in the first-line setting for PD‑L1‑positive advanced NSCLC, potentially bringing a new option to a broad population of patients with lung cancer." About sac-TMT( 佳泰莱 ® ) Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as 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 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, as a topoisomerase I inhibitor, 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. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & 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). 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) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) epidermal growth factor receptor (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'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 (BTDs) by the National Medical Products Administration (NMPA). Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA®) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 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. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&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 world. 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, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, 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 . SOURCE Kelun-Biotech 21% more press release views with Request a Demo

2026年5月30日，四川科伦博泰生物医药股份有限公司(下称“科伦博泰”或“公司” 6990.HK)宣布，在美国芝加哥举行的2026年美国临床肿瘤学会(ASCO)年会上，同济大学附属东方医院周彩存教授以口头报告形式公布了靶向人滋养细胞表面抗原2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT，亦称SKB264/MK-2870)(佳泰莱®)联合帕博利珠单抗(可瑞达®1，默沙东的抗程序性细胞死亡蛋白-1(PD-1)单抗)一线治疗程序性细胞死亡配体1(PD-L1)肿瘤细胞阳性比例分数(TPS)≥1%非小细胞肺癌(NSCLC)的III期OptiTROP-Lung05研究结果(摘要编号#8506，肺癌-转移性非小细胞)。 芦康沙妥珠单抗(sac-TMT)采用独特双功能连接子以及基于贝洛替康衍生物的差异化有效载荷设计。其连接子通过半胱氨酸偶联，一方面与具有高亲和力及靶向效应的TROP2单抗沙妥珠单抗结合，另一方面在溶酶体中可从中等毒性新型拓扑异构酶I抑制剂有效载荷pH敏感裂解，最大限度将有效载荷递送至肿瘤细胞，药物抗体比(DAR)达到7.4。 在OptiTROP-Lung05研究中，共有413例患者被随机(1:1)分配接受芦康沙妥珠单抗(sac-TMT)联合帕博利珠单抗或帕博利珠单抗单药治疗。 于数据截止时间(2025年9月29日)，中位随访10.5个月，研究数据显示： 芦康沙妥珠单抗(sac-TMT)联合帕博利珠单抗组的无进展生存期(PFS)相较于帕博利珠单抗单药组显示出统计学意义和临床意义的显著改善。由盲态独立中心评审(BICR)评估的中位PFS为尚未达到(NR) vs 5.7个月(HR=0.35; 95% CI: 0.26-0.47; p<0.0001)，12个月PFS率为62.4% vs 29.0%。 预设各亚组获益一致：在PD-L1 TPS≥50%及TPS 1-49%患者中，PFS HR分别为0.47 (95% CI: 0.29-0.77)和0.28 (95% CI: 0.19-0.41)；在非鳞状和鳞状NSCLC患者中，PFS HR分别为0.28 (95% CI: 0.18-0.43)和0.44 (95% CI: 0.29-0.66)。 总生存期(OS)尚未成熟但显示积极获益趋势：中位OS分别为NR vs 14.5个月(HR=0.55；95% CI: 0.36-0.85)；12个月OS率为80.4% vs 68.9%。 联合治疗组较帕博利珠单抗单药组提高了客观缓解率(ORR)(70.2% vs 42.0%)、深度缓解率(49.0% vs 25.9%) 及12个月持续缓解率(77.7% vs 59.4%)。 联合治疗组≥3级治疗期间不良事件(TEAEs)发生率更高，主要是由芦康沙妥珠单抗预期发生的血液学不良事件所致；两组因TEAE导致帕博利珠单抗永久停药的发生率相似，未发生芦康沙妥珠单抗相关的死亡；特别关注的不良事件(AEOSIs)与各试验药物已知的不良反应谱一致，未发现新的安全性信号。 期中分析结果表明，相较于帕博利珠单抗单药，芦康沙妥珠单抗(sac-TMT)联合帕博利珠单抗可显著延长PFS并降低疾病进展或死亡风险，且预设的各亚组中(包括PD-L1表达水平、组织学类型)均表现出一致的PFS获益；同时已观察到OS的获益趋势。联合治疗组整体安全性可控，且与芦康沙妥珠单抗(sac-TMT)单药或帕博利珠单抗单药已建立的安全性特征一致。 值得关注的是，OptiTROP‑Lung05研究成果已同步刊登国际顶刊《柳叶刀》（The Lancet, 影响因子IF=88.5），说明其临床价值与学术价值获得了国际一流学会及权威期刊的双重认可。 全国牵头主要研究者、同济大学附属东方医院周彩存教授表示：OptiTROP-Lung05研究取得的积极结果令人振奋。不仅为芦康沙妥珠单抗在肺癌治疗中的‘应用前移’提供了循证证据，更率先验证了‘ADC+IO’协同策略在PD-L1阳性晚期NSCLC一线治疗中的可行性，有望为广大肺癌患者带来全新的生存希望。 关于芦康沙妥珠单抗（sac-TMT，佳泰莱®) 作为公司的核心产品，芦康沙妥珠单抗(sac-TMT)是一款公司拥有自主知识产权的新型TROP2 ADC，针对NSCLC、乳腺癌(BC)、胃癌(GC)、妇科肿瘤及泌尿生殖系统肿瘤等晚期实体瘤。芦康沙妥珠单抗(sac-TMT)采用独特双功能连接子开发而成。该连接子一方面通过与抗TROP2单抗沙妥珠单抗形成不可逆结合，另一方面在溶酶体中可从贝洛替康衍生物拓扑异构酶I抑制剂有效载荷pH敏感裂解，从而最大限度将有效载荷递送至肿瘤细胞，药物抗体比(DAR)达到7.4。芦康沙妥珠单抗(sac-TMT)通过重组抗TROP2人源化单克隆抗体特异性识别肿瘤细胞表面的TROP2，其后被肿瘤细胞内吞并于细胞内释放有效载荷KL610023。KL610023作为拓扑异构酶I抑制剂，可诱导肿瘤细胞DNA损伤，进而导致细胞周期阻滞及细胞凋亡。此外，其亦于肿瘤微环境中释放KL610023。鉴于KL610023具有细胞膜渗透性，其可实现旁观者效应，即杀死邻近的肿瘤细胞。 于2022年5月，公司授予默沙东(美国新泽西州罗威市默克公司的商号)在大中华区(包括中国内地、香港、澳门及台湾)以外的所有地区开发、使用、制造及商业化芦康沙妥珠单抗(sac-TMT)的独家权利。 截至目前，芦康沙妥珠单抗(sac-TMT)的4项适应症已于中国获批上市，分别用于：1)既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性三阴性乳腺癌(TNBC)；2)经表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKI)和含铂化疗治疗后进展的表皮生长因子受体(EGFR)基因突变阳性的局部晚期或转移性非鳞状NSCLC；3)经EGFR-TKI治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状NSCLC；4)既往接受过内分泌治疗且在晚期疾病阶段接受过至少一线化疗的不可切除或转移性的激素受体阳性(HR+)且人类表皮生长因子受体2阴性(HER2-) (免疫组织化学(IHC) 0、IHC 1+或IHC 2+/原位杂交(ISH)-) BC；其中前2项适应症已经被纳入医保范围，将为更多乳腺癌和非小细胞肺癌患者带来临床获益。此外，芦康沙妥珠单抗(sac-TMT)已获国家药品监督管理局(NMPA)授予6项突破性疗法认定(BTD)。 芦康沙妥珠单抗(sac-TMT)是全球首个在肺癌适应症获批上市的TROP2 ADC药物。芦康沙妥珠单抗(sac-TMT)用于联合帕博利珠单抗(可瑞达®)一线治疗PD-L1肿瘤比例分数(TPS)≥1%的EGFR基因突变阴性和间变性淋巴瘤激酶(ALK)阴性的局部晚期或转移性NSCLC的新增适应症上市申请已获NMPA受理，并被纳入优先审评审批程序。目前，科伦博泰已在中国开展9项注册性临床研究。默沙东已启动17项正在进行的芦康沙妥珠单抗(sac-TMT)作为单药疗法或联合帕博利珠单抗或其他抗癌药物用于多种类型癌症的全球性III期临床研究(这些研究由默沙东申办并主导)。 关于科伦博泰 四川科伦博泰生物医药股份有限公司(简称“科伦博泰生物”，股票代码：6990.HK)是科伦药业控股子公司，专注于创新生物技术药物及小分子药物的研发、生产、商业化及国际合作。公司围绕全球和中国未满足的临床需求，重点布局肿瘤、自身免疫和代谢等重大疾病领域，建设国际化药物研发与产业化平台，致力于成为在创新药物领域国际领先的企业。公司目前拥有30余个重点创新药项目，其中4个项目8个适应症已获批上市，1个项目处于NDA阶段，10余个项目正处于临床阶段。公司成功构建了享誉国际的专有ADC及新型偶联药物平台OptiDCTM，已有2个ADC项目5个适应症获批上市，多个ADC或新型偶联药物产品处于临床或临床前研究阶段。更多信息请访问官网https://kelun-biotech.com/。 [1]可瑞达®(帕博利珠单抗)为美国新泽西州罗威市默克公司的附属公司Merck Sharp & Dohme LLC (默沙东)的注册商标 说明：本文仅用于披露截止发文之日科伦博泰最新进展，仅供医疗卫生专业人士交流，并非产品推广广告，亦不构成投资建议 媒体联系: klbio_pr@kelun.com