芦康沙妥珠单抗(Sacituzumab tirumotecan) - 药物靶点：Top I x Trop-2_在研适应症：HR阳性/HER2阴性乳腺癌，EGFR突变的非小细胞肺癌，EGFR阳性非鳞状非小细胞肺癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Sac-TMT、TROP-2-targeted antibody-drug conjugate、A-264

+ [7]

靶点

Top I x Trop-2

作用方式

抑制剂

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)、Trop-2抑制剂(肿瘤相关钙信号传感器2抑制剂)

治疗领域

肿瘤呼吸系统疾病皮肤和肌肉骨骼疾病+ [6]

在研适应症

HR阳性/HER2阴性乳腺癌EGFR突变的非小细胞肺癌EGFR阳性非鳞状非小细胞肺癌+ [70]

非在研适应症

微卫星稳定型子宫内膜癌复发性食管鳞状细胞癌

原研机构

四川科伦药业股份有限公司

在研机构

KLUS Pharma, Inc.

Merck Sharp & Dohme LLC

四川科伦博泰生物医药股份有限公司

+ [2]

非在研机构-

权益机构

四川科伦博泰生物医药股份有限公司

Merck Sharp & Dohme Corp.

Merck & Co., Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

中国 (2024-11-22),

三阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、附条件批准 (中国)、突破性疗法 (中国)、优先审评 (中国)

登录后查看时间轴

结构/序列

使用我们的ADC技术数据为新药研发加速。

登录

或

查看完整样例数据

Sequence Code 27958L

来源: *****

Sequence Code 319372635H

来源: *****

关联

141

项与芦康沙妥珠单抗相关的临床试验

NCT07511023

/ Not yet recruiting临床2期IIT

Phase 2 Trial Of Sacituzumab Tirumotecan For Treatment Of Refractory Metastatic Or Unresectable Squamous Cell Carcinoma Of The Anus/Rectum

To look at the effectiveness of sacituzumab tirumotecan (MK-2870) in treating participants with treatment-refractory unresectable and/or metastatic anal/rectal cancer.

开始日期2026-09-25

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT07639086

/ Not yet recruiting临床2期IIT

Sacituzumab Tirumotecan in Patients With Neuroendocrine Prostate Cancer After Progression on Prior Chemotherapy

This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.

开始日期2026-08-31

申办/合作机构

Virginia Commonwealth University

[+1]

NCT07701681

/ Not yet recruiting临床2期IIT

A Single-Arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) Combined With Tagitanlimab (KL-A167) as Second-Line Therapy for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma

This is a single-arm, multi-center phase II study to evaluate the efficacy and safety of sacituzumab tirumotecan (Sac-TMT/SKB264) combined with tagitanlimab (KL-A167) as 2nd line therapy for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) or gastric/gastroesophageal junction adenocarcinoma (G/GEJA). A total of 75 participants are planned to be enrolled with 10 in the safety lead-in phase and 33 ESCC and 42 G/GEJA in expansion phase, seperately.

开始日期2026-08-31

申办/合作机构

中山大学

100 项与芦康沙妥珠单抗相关的临床结果

登录后查看更多信息

100 项与芦康沙妥珠单抗相关的转化医学

登录后查看更多信息

100 项与芦康沙妥珠单抗相关的专利（医药）

登录后查看更多信息

35

项与芦康沙妥珠单抗相关的文献（医药）

2026-05-01·LANCET

Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial

Article

作者: Wang, Haiyong ; Fan, Yun ; Yao, Yu ; Wei, Youneng ; Su, Cuiyun ; Zhou, Caicun ; Jin, Xiaoping ; Xiong, Anwen ; Yang, Yunpeng ; Zhang, Lemeng ; Yu, Yan ; Du, Xiaobo ; Qing, Yan ; Pu, Xingxiang ; Ge, Junyou ; Che, Guowei ; Chen, Bolin ; Yu, Qitao ; Liu, Zhentian ; Fang, Yong ; Li, Xingya ; Cui, Jiuwei ; Zhou, Ming ; Chen, Peng ; Wang, Hui ; Huang, Zhangzhou ; Jiang, Guanming ; Zhong, Hua ; Yi, Tienan ; Luo, Hui ; Liu, Chunling ; Yao, Wenxiu ; Zheng, Wei ; Wang, Qiming ; He, Lang ; Song, Xia

BACKGROUND:

Sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2-targeting antibody-drug conjugate, combined with programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitors, has shown promising antitumour activity as first-line therapy for non-small-cell lung cancer (NSCLC) in early-phase studies. Our aim was to evaluate the efficacy and safety of sac-TMT plus pembrolizumab as first-line treatment for patients with PD-L1-positive advanced NSCLC without targetable genomic alterations.

METHODS:

In this randomised, open-label, phase 3 trial (OptiTROP-Lung05) conducted across 68 hospitals in China, eligible patients had locally advanced or metastatic NSCLC without targetable genomic alterations and a PD-L1 tumour proportion score (TPS) of 1% or greater. Patients were randomly assigned (1:1) to receive sac-TMT (4 mg/kg on days 1, 15, and 29) plus pembrolizumab (400 mg fixed dose on day 1), or pembrolizumab alone, administered intravenously every 6 weeks. The primary endpoint was progression-free survival, as assessed by blinded independent central review in the intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT06448312). Recruitment is complete, with the trial ongoing and the final analysis to be reported later.

FINDINGS:

Between June 7, 2024, and March 27, 2025, 741 patients were screened and 413 eligible patients were randomly assigned to receive sac-TMT plus pembrolizumab (n=208) or pembrolizumab alone (n=205). At the prespecified interim analysis, conducted after a median follow-up of 10·5 months (IQR 8·7-12·5), median progression-free survival was significantly longer with sac-TMT plus pembrolizumab than with pembrolizumab alone (not reached vs 5·7 months; stratified hazard ratio [HR] 0·35 [95% CI 0·26-0·47]; p<0·0001). The progression-free survival benefit was broadly consistent across subgroups, including patients with PD-L1 TPS of 1-49% (HR 0·28 [95% CI 0·19-0·41]) and those with PD-L1 TPS of 50% or greater (HR 0·47 [0·29-0·77]). Grade 3 or higher treatment-emergent adverse events occurred in 115 (55%) of 208 patients in the sac-TMT plus pembrolizumab group and 64 (31%) of 204 patients in the pembrolizumab group.

INTERPRETATION:

Among patients with PD-L1-positive advanced NSCLC without targetable genomic alterations, first-line treatment with sac-TMT plus pembrolizumab significantly prolonged progression-free survival compared with pembrolizumab alone. Therefore, sac-TMT plus pembrolizumab has the potential to redefine first-line treatment for patients with PD-L1-positive advanced NSCLC without targetable genomic alterations.

FUNDING:

Sichuan Kelun-Biotech Biopharmaceutical.

2026-03-23·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[Expert consensus on the clinical application of TROP2-targeted antibody-drug conjugates in non-small cell lung cancer (2026 edition)].

Review

Antibody-drug conjugates (ADCs) have demonstrated groundbreaking progress in the treatment of non-small cell lung cancer (NSCLC). Trophoblast cell surface antigen 2 (TROP2) has emerged as a pivotal therapeutic target, and TROP2-directed ADCs, including Sacituzumab Tirumotecan, Datopotamab Deruxtecan, and Sacituzumab Govitecan have shown substantial antitumor activity and survival benefits in clinical studies. To further standardize the clinical use and safety management of TROP2 ADCs, this expert consensus systematically reviews current evidence regarding their efficacy and safety in NSCLC. Particular emphasis is placed on strategies for the prevention and management of treatment-related adverse events such as mucositis, myelosuppression, and gastrointestinal toxicities, aiming to provide guidance for the rational and safe application of TROP2 ADCs in NSCLC.

2026-03-01·ANNALS OF ONCOLOGY

Sacituzumab tirumotecan in participants with advanced or metastatic urothelial carcinoma and disease progression after chemotherapy and immune checkpoint inhibitors

Article

作者: Ge, Y ; Liu, T ; Wang, X ; Zhang, S ; Yuan, F ; Seneviratne, L ; Li, Y ; Li, X ; Wang, S ; Jiang, K ; Chen, X ; Zhang, M ; Ge, J ; Blumenthal, G ; Liu, Y ; Zhou, F ; Ye, D ; Akala, O ; Jiang, S ; Chen, M ; Zhang, X ; Shi, Y ; Yu, G ; Zhu, Y

BACKGROUND:

Trophoblast cell-surface antigen 2 (TROP2) is overexpressed in advanced or metastatic urothelial cancer (UC), representing a promising therapeutic target. Sacituzumab tirumotecan (sac-TMT) is a TROP2-directed antibody-drug conjugate with a unique, bifunctional linker that maximizes payload delivery to tumor cells. We present preliminary results for sac-TMT monotherapy from cohort 9 of the phase 1/2 2870-001/KL264-01 study in participants with advanced or metastatic UC.

PARTICIPANTS AND METHODS:

Eligible participants with locally advanced or metastatic UC and disease progression on one or more prior line of platinum-based chemotherapy and anti-programmed cell death protein 1/programmed cell death-ligand 1 therapy received sac-TMT 5 mg/kg intravenously every 2 weeks until disease progression, unacceptable toxicity, or participant/physician decision. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST version 1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

By data cut-off (17 February 2025), 49 participants were treated with sac-TMT; 37 (76%) had received two or more prior lines of therapy. Median follow-up for this analysis was 18.8 months. The confirmed ORR was 31% [95% confidence interval (CI), 18% to 45%] and the disease control rate was 71% (95% CI 57% to 83%). Median DOR was not reached [range 2.1-22.2+ (+ indicates censored data for the longest DOR, suggesting that patients may have achieved longer remission duration) months], and the 12-month probability of sustained response was 53%. Median PFS and OS were 5.5 months (95% CI 3.6-7.2 months) and 12.1 months (95% CI, 9.9-15.3 months), with 18-month rates of 26% and 33%, respectively. Grade 3/4 treatment-related adverse events (AEs) occurred in 31 participants (63%), and the most common (≥5%) were anemia (41%), decreased neutrophil count (35%), decreased white blood cell count (20%), stomatitis (12%), and decreased platelet count (8%). There were no grade 5 treatment-related AEs or febrile neutropenia events.

CONCLUSIONS:

Sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pretreated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population.

3,629

项与芦康沙妥珠单抗相关的新闻（医药）

9 小时之前

·生物世界

Nature：结直肠癌的致命弱点和治疗新靶点——TROP2

撰文丨王聪编辑丨王多鱼排版丨水成文结直肠癌（CRC）是全球癌症相关死亡的第二大原因，其高致死率主要归因于诊断时已存在播散性肿瘤细胞以及系统性治疗效果不佳。约 90% 的结直肠癌病例属于微卫星稳定型，其标准治疗方案为细胞抑制剂联合疗法。然而，细胞可塑性似乎是导致治疗耐药的关键因素。此外，靶向血管内皮生长因子受体或表皮生长因子受体可提高临床疗效。这些联合治疗方案早在十多年前就已获批，但晚期结直肠癌患者的五年总生存率仅为 12%，凸显了晚期结直肠癌患者仍亟需更有效的治疗选择。 2026 年 7 月 1 日，德国海德堡干细胞技术与实验医学研究所的研究人员在国际顶尖学术期刊 Nature 上发表了题为：TROP2 targeting reveals therapy-driven cell state dynamics in colorectal cancer 的研究论文。该研究确定了结直肠癌细胞的一个关键标志物——TROP2，其标记了与转移和治疗耐药相关的低 WNT 信号、胎儿样肿瘤细胞状态，进一步证明了 TROP2 靶向的 ADC 药物能够特异性地攻击这些引发转移和治疗耐药的结直肠癌细胞，并且与标准疗法联合使用时，可显著提高治疗效果。这些发现表明，TROP2 是结直肠癌的治疗脆弱点，并强调了靶向肿瘤细胞状态对于改善晚期癌症治疗效果和克服耐药的重要性。近年来，抗体药物偶联物（ADC）作为一种靶向治疗策略，在多种癌症类型中引起了广泛关注。TROP2 是一种跨膜糖蛋白，由 TACSTD2 基因编码，在多种癌细胞中高表达，而在大多数成年组织中则不表达。TROP2 抗原的发现激发了针对该靶点开发 ADC 药物的浓厚兴趣，目前，已有两款 TROP2 靶向的 ADC 药物获批上市——戈沙妥珠单抗（Sacituzumab govitecan）和芦康沙妥珠单抗（Sacituzumab tirumotecan），用于治疗转移性乳腺癌等癌症。这些成功案例，推动了大量 TROP2 靶向的 ADC 药物进入临床开发阶段，涵盖从 I 期到 III 期的多项研究，涉及多种癌症类型。在这项新研究中，研究团队鉴定出跨膜糖蛋白 TROP2 是预后不良结直肠癌（CRC）的生物标志物，其与低 WNT 信号（WNTlow）、胎儿样肿瘤细胞状态相关，而该状态与转移和治疗耐药密切相关。功能分析表明，TROP2+ 细胞表现出依赖于微环境的干细胞样能力，并具备启动转移性生长的潜能。鉴于这些有害的肿瘤状态汇聚于细胞表面抗原 TROP2，研究团队探索了利用临床相关的 TROP2 靶向的 ADC 药物对该细胞群体进行治疗性干预。时间分辨分析揭示了高 WNT 信号 LGR5+（WNThigh LGR5+）状态与低 WNT 信号 TROP2+（WNTlow TROP2+）胎儿样状态之间肿瘤细胞状态组成的治疗相关动态变化。常规化疗可诱导表达 TROP2 的细胞的产生，而 TROP2 靶向的 ADC 则选择性靶向这些细胞群体并重塑肿瘤细胞状态景观。利用这种可塑性，将 TROP2 靶向的 ADC 药物与化疗联合使用，在患者来源模型中增强了抗肿瘤疗效。综上所述，这些研究结果将 TROP2 确定为结直肠癌的治疗脆弱点，并强调了靶向肿瘤细胞状态对于改善晚期癌症治疗效果和克服耐药的重要性。论文链接： https://www.nature.com/articles/s41586-026-10705-2 设置星标，不错过精彩推文开放转载欢迎转发到朋友圈和微信群微信加群为促进前沿研究的传播和交流，我们组建了多个专业交流群，长按下方二维码，即可添加小编微信进群，由于申请人数较多，添加微信时请备注：学校/专业/姓名，如果是PI/教授，还请注明。点在看，传递你的品味

9 小时之前

·Firstwordpharma

Kelun's Merck & Co.-partnered ADC scores late-stage win in front-line PD-L1-negative NSCLC

Kelun-Biotech reported Tuesday that its antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab) cleared yet another late-stage study in front-line non–small-cell lung cancer (NSCLC), specifically in patients with locally advanced or metastatic disease.Merck has held ex-China rights to Kelun's TROP2-targeting ADC since 2022; the drug has four approved indications in China — where it is marketed as Jia Tai Lai — spanning triple-negative breast cancer, EGFR mutant-positive NSCLC and HR+/HER2- breast cancer. For more on Merck and Kelun's partnership, see — Vital Signs: Merck & Co. ups the ante for its big bet on sac-TMT.The Phase III OptiTROP-Lung06 trial enrolled 432 patients with a PD-L1 tumour proportion score <1%, who were randomised to receive either sac-TMT plus Keytruda or Keytruda plus pemetrexed and platinum-based chemotherapy.Top-line results showed the trial met its primary endpoint of blinded independent central review (BICR)-assessed progression-free survival (PFS) at a pre-specified interim analysis, with the sac-TMT plus Keytruda regimen demonstrating a statistically significant and clinically meaningful improvement over Keytruda plus chemotherapy, alongside a positive trend on overall survival.Meanwhile, the combination's safety profile was consistent with previous studies, with no new signals identified. Kelun plans to discuss the findings with China's Center for Drug Evaluation.The latest findings follow sac-TMT plus Keytruda's success in the Phase III OptiTROP-Lung05 study, wherein the combination showed a PFS advantage over Keytruda alone in treatment-naïve patients with PD-L1-positive NSCLC. Additional data presented at this year's American Society of Clinical Oncology (ASCO) meeting showed that after a median follow-up of 10.5 months, the ADC-immunotherapy duo slashed the risk of disease progression or death by 65% versus Keytruda monotherapy."The positive results of… OptiTROP-Lung05 and OptiTROP-Lung06 studies confirm the strong synergetic effect of sac-TMT combined with [Keytruda], supporting the potential of this combination regimen to benefit the broad first-line NSCLC population," said Kelun CEO Michael GE.Sac-TMT is currently being evaluated in ten registrational lung cancer studies, including five in China and five globally. The ADC also recently succeeded in a late-stage endometrial cancer study — one of Merck's 17 Phase III global trials in its TroFuse programme.

临床3期ASCO会议临床结果抗体药物偶联物免疫疗法

9 小时之前

·Biotech前瞻

PFS优于免疫化疗丨芦康沙妥珠单抗拿下PD-L1阴性肺癌一线Ⅲ期

引言 2026年7月15日，科伦博泰宣布，TROP2 ADC芦康沙妥珠单抗（sac-TMT，SKB264/MK-2870）联合帕博利珠单抗，一线治疗PD-L1阴性局部晚期或转移性非鳞状非小细胞肺癌的Ⅲ期OptiTROP-Lung06研究，在预设期中分析中达到无进展生存期主要终点。根据公司披露，试验组相较帕博利珠单抗联合培美曲塞及铂类化疗显著延长PFS，OS出现积极趋势，未发现新的安全性信号。这是全球首个在驱动基因阴性、PD-L1 TPS＜1%非鳞状NSCLC一线治疗中，ADC联合免疫治疗对比免疫联合化疗达到主要终点的Ⅲ期研究。这项结果的重要性主要来自对照方案。OptiTROP-Lung06直接挑战KEYNOTE-189建立的一线标准，试图以TROP2 ADC替代培美曲塞和铂类，重新构建PD-L1阴性非鳞状NSCLC的一线治疗方案。一、直接挑战KEYNOTE-189 对于没有可用靶向药物的晚期非鳞状NSCLC，帕博利珠单抗联合培美曲塞和铂类化疗是目前应用最广泛的一线方案之一。在PD-L1 TPS＜1%患者中，免疫联合化疗仍能改善生存。KEYNOTE-189和KEYNOTE-407的汇总分析显示，相较化疗，免疫联合化疗的OS和PFS风险比分别为0.64和0.66，但五年OS率仍只有12.5%。这也是PD-L1阴性患者继续寻找新方案的临床基础。 PD-L1 TPS＜1%并不等于完全缺乏免疫反应。PD-L1只是特定标本和时间点上的肿瘤细胞膜表达指标，受取材部位、肿瘤异质性和检测平台影响。但从群体层面看，这类患者对PD-1单药的响应概率较低，通常需要化疗提供快速减瘤并增强免疫反应。 OptiTROP-Lung06计划入组约432例患者，研究所定义的驱动基因阴性包括无EGFR敏感突变、ALK融合及其他已有对应靶向治疗的基因改变。患者随机接受sac-TMT联合帕博利珠单抗，或帕博利珠单抗联合培美曲塞及顺铂或卡铂，主要终点为盲态独立中心评审的PFS。目前可以确认的是，sac-TMT联合帕博利珠单抗在PFS上优于标准免疫化疗。公告尚未披露PFS HR、中位PFS、ORR、OS成熟度及具体不良事件，因此还不能判断OS是否显著改善，也不能得出安全性优于化疗的结论。二、从Ⅱ期信号到两项Ⅲ期阳性，一线证据逐步建立 sac-TMT联合免疫治疗的开发始于Ⅱ期OptiTROP-Lung01。该研究评估sac-TMT联合PD-L1单抗塔戈利单抗一线治疗晚期NSCLC，每三周和每两周给药队列的确认ORR分别为40.0%和66.7%，中位PFS分别为15.4个月和尚未达到。尽管两个队列并非随机比较，但结果支持后续采用更密集的给药方式进入Ⅲ期。随后开展的OptiTROP-Lung05纳入413例PD-L1 TPS≥1%、无可靶向基因改变的晚期NSCLC患者，比较sac-TMT联合帕博利珠单抗与帕博利珠单抗单药。中位随访10.5个月时，联合组中位PFS尚未达到，对照组为5.7个月，疾病进展或死亡风险降低65%（HR=0.35）；两组ORR分别为70.2%和42.0%，12个月PFS率分别为62.4%和29.0%。PFS获益同时出现在PD-L1 TPS 1%—49%、TPS≥50%以及鳞状和非鳞状亚组。联合组≥3级治疗期间不良事件发生率为55.3%，高于帕博利珠单抗组的31.4%。主要≥3级不良事件包括中性粒细胞减少、贫血和口腔炎，说明疗效提升伴随可观察的血液学和黏膜毒性。 OptiTROP-Lung05证明sac-TMT可以增强免疫单药疗效，OptiTROP-Lung06则进一步证明其PFS可以超过免疫联合化疗。两项Ⅲ期结果已经覆盖PD-L1阳性NSCLC和PD-L1阴性非鳞状NSCLC，但尚未覆盖PD-L1阴性鳞癌，因此不能表述为完成一线NSCLC全人群覆盖。三、替代的是传统化疗，并非取消细胞毒治疗 OptiTROP-Lung06不宜被称为严格意义上的Chemo-free研究。 sac-TMT虽然去除了培美曲塞和铂类，但仍携带贝洛替康衍生的拓扑异构酶Ⅰ抑制剂KL610023。其核心变化是利用抗体重新分配细胞毒载荷的体内暴露。 sac-TMT由人源化抗TROP2抗体、双功能连接子和KL610023组成，平均药物抗体比约为7.4。连接子与抗体形成不可逆连接，并在溶酶体酸性环境中释放载荷。KL610023进入肿瘤细胞后诱导DNA损伤、细胞周期阻滞和凋亡，同时依靠膜通透性产生旁观者效应，对邻近TROP2低表达细胞形成杀伤。 ADC与免疫治疗的联合具有药理学依据。ADC减少肿瘤负荷，并可能通过免疫原性细胞死亡、肿瘤抗原释放和抗原呈递增强免疫反应；PD-1阻断则维持T细胞活性。但OptiTROP-Lung06尚未披露免疫细胞浸润、T细胞克隆扩增或PD-L1动态变化等转化数据，因此“激活PD-L1阴性免疫微环境”目前仍属于机制推测。两项Ⅲ期研究均未设置TROP2表达门槛，有利于扩大适用人群，也留下了生物标志物问题。后续需要明确不同TROP2表达水平、脑转移、肝转移及STK11/KEAP1等共突变人群能否获得一致获益。四、同类产品相继受挫，sac-TMT的阳性并非TROP2类别效应 TROP2 ADC在肺癌中的临床结果已经出现明显分化。吉利德的戈沙妥珠单抗在经治NSCLC的EVOKE-01研究中未达到OS主要终点。2026年6月，其联合帕博利珠单抗一线治疗PD-L1 TPS≥50%转移性NSCLC的Ⅲ期EVOKE-03研究又被终止：PFS仅数值改善，未达到统计学显著性，最终获得OS阳性的可能性较低。第一三共/阿斯利康的德达博妥单抗在TROPION-Lung01研究中达到PFS终点，但整体人群OS为12.9个月和11.8个月，HR为0.94，同样未达到统计学显著性。目前，TROPION-Lung07正在评估德达博妥单抗联合帕博利珠单抗、伴或不伴铂类化疗，对比免疫联合化疗，用于PD-L1＜50%的非鳞状NSCLC一线治疗，是与OptiTROP-Lung06最接近的全球竞争性研究。这些结果说明，同为TROP2 ADC和拓扑异构酶Ⅰ载荷，临床表现仍可能存在较大差异。抗体表位、连接子稳定性、载荷结构、DAR、给药频率及毒性管理共同决定产品的治疗窗口。 OptiTROP-Lung05和Lung06连续达到主要终点，增加了sac-TMT分子差异化成立的可能性，但在缺少ADC头对头研究的情况下，仍不能通过跨试验数据直接判定产品优劣。五、中国进入商业化扩展期，全球注册仍存在关键空白截至2026年7月，sac-TMT已在中国获批4项适应证，分别用于经多线治疗的局部晚期或转移性三阴性乳腺癌、EGFR-TKI及含铂化疗后进展的EGFR突变非鳞状NSCLC、EGFR-TKI治疗后进展的EGFR突变非鳞状NSCLC，以及既往接受过内分泌治疗且在晚期阶段接受过至少一线化疗的HR+/HER2−不可切除或转移性乳腺癌。其中，最早获批的三阴性乳腺癌和经EGFR-TKI及含铂化疗后进展的NSCLC两项适应证，已纳入2025年国家医保药品目录。公司已在中国启动9项注册性研究，并获得6项突破性疗法认定。基于OptiTROP-Lung05，sac-TMT联合帕博利珠单抗治疗PD-L1 TPS≥1% NSCLC的新增适应症申请已经获CDE受理并进入优先审评。OptiTROP-Lung06则可能进一步扩大其在中国一线肺癌市场的覆盖范围。科伦博泰保留sac-TMT大中华区权益，默沙东拥有大中华区以外的开发和商业化权利。目前默沙东已启动17项全球Ⅲ期研究，覆盖肺癌、乳腺癌、胃癌及妇科肿瘤，其中肺癌包括五项全球多中心Ⅲ期研究。但默沙东尚未启动一项与OptiTROP-Lung06完全对应的PD-L1低表达或阴性非鳞状NSCLC一线全球注册研究。sac-TMT目前也尚未在美国或欧洲获批。OptiTROP-Lung06可以为全球开发决策提供依据，但中国研究阳性并不等同于全球注册路径已经打通。结语 OptiTROP-Lung06已经证明，在PD-L1阴性、驱动基因阴性的非鳞状NSCLC中，sac-TMT联合帕博利珠单抗能够在PFS上超过帕博利珠单抗联合培美曲塞及铂类化疗。这项结果支持TROP2 ADC替代传统化疗骨架的可行性，也提高了sac-TMT在一线肺癌和默沙东全球ADC管线中的战略价值。下一步需要关注的不是“是否达到主要终点”，而是PFS改善幅度、OS成熟结果、与免疫化疗相比的安全性和生活质量，以及不同TROP2表达和高风险分子亚组的获益一致性。如果完整数据同时支持疗效、长期安全性和患者获益，sac-TMT联合帕博利珠单抗有望在中国形成新的非鳞状NSCLC一线选择，并推动默沙东补充相应的全球注册布局。

100 项与芦康沙妥珠单抗相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	中国	四川科伦博泰生物医药股份有限公司	2026-02-02
EGFR突变的非小细胞肺癌	中国	四川科伦博泰生物医药股份有限公司	2025-09-30
EGFR阳性非鳞状非小细胞肺癌	中国	四川科伦博泰生物医药股份有限公司	2025-03-04
三阴性乳腺癌	中国	四川科伦博泰生物医药股份有限公司	2024-11-22

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
局部晚期非小细胞肺癌	申请上市	中国	四川科伦博泰生物医药股份有限公司	2026-05-09
转移性非小细胞肺癌	申请上市	中国	四川科伦博泰生物医药股份有限公司	2026-05-09
PD-L1阳性非小细胞肺癌	申请上市	中国	四川科伦博泰生物医药股份有限公司	2026-05-09
膀胱癌	临床3期	美国	默沙东研发（中国）有限公司	2026-04-23
膀胱癌	临床3期	美国	Merck Sharp & Dohme LLC	2026-04-23
膀胱癌	临床3期	中国	Merck Sharp & Dohme LLC	2026-04-23
膀胱癌	临床3期	日本	Merck Sharp & Dohme LLC	2026-04-23
膀胱癌	临床3期	日本	默沙东研发（中国）有限公司	2026-04-23
膀胱癌	临床3期	阿根廷	默沙东研发（中国）有限公司	2026-04-23
膀胱癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2026-04-23

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT07216703 (TroFuse-036, ASCO2026)	临床3期	PD-L1阳性宫颈癌一线 \| 维持 PD-L1-positive	1,723	sacituzumab tirumotecan + pembrolizumab + bevacizumab (Part 1 Safety Run-in)	繭壓壓簾鹽遞膚鏇製廠(廠繭窪齋鹹窪夢繭衊蓋) = 鑰遞窪鏇簾繭構範鹹醖衊蓋鏇膚築網願壓鬱鑰 (鑰醖顧鹽鬱餘網憲餘網, 30.6 ~ NR) 更多	积极	2026-05-29
				sacituzumab tirumotecan + pembrolizumab ± bevacizumab	繭壓壓簾鹽遞膚鏇製廠(廠繭窪齋鹹窪夢繭衊蓋) = 鹹憲襯鹽襯夢積糧簾醖衊蓋鏇膚築網願壓鬱鑰 (鑰醖顧鹽鬱餘網憲餘網, 27.7 ~ NR) 更多
NCT06448312 (OptiTROP-Lung05, ASCO2026)	临床3期	PD-L1阳性非小细胞肺癌一线 PD-L1-positive	413	Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab	齋顧鹹壓糧觸醖構鹹齋(簾願鑰構遞顧遞繭構壓) = 顧願憲壓餘衊簾鹹夢簾糧憲壓鏇鑰窪艱艱遞範 (願簾積憲窪鏇遞窪簾築 ) 更多	积极	2026-05-29
				Pembrolizumab	齋顧鹹壓糧觸醖構鹹齋(簾願鑰構遞顧遞繭構壓) = 膚願醖壓廠遞獵齋鏇壓糧憲壓鏇鑰窪艱艱遞範 (願簾積憲窪鏇遞窪簾築 ) 更多
NCT06448312 (OptiTROP-Lung05, Pubmed \| Lancet)	临床3期	PD-L1阳性非小细胞肺癌一线 PD-L1-positive	413	Sacituzumab tirumotecan plus pembrolizumab	願蓋壓製鬱鹽襯範壓鹹(顧蓋鑰網範鹽簾醖範遞) = 積鑰艱鹹壓窪衊觸製鬱醖遞壓鑰蓋簾鏇餘築網 (夢觸廠築艱醖糧築廠製 ) 更多	积极	2026-05-01
				Pembrolizumab	繭選糧繭製獵壓觸壓獵(夢範繭淵壓鹽願顧齋鬱) = 構繭積鑰齋簾簾夢衊網遞獵遞鬱壓鑰廠蓋顧窪 (廠淵憲糧襯遞廠夢淵窪 )
NCT05631262 (OptiTROP-Lung03, ESMO_ELCC2026 \| PRNewswire) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	137	Sacituzumab Tirumotecan	衊膚鏇廠鬱鹹觸齋繭築(網襯鏇範壓夢壓膚蓋選) = 獵襯壓遞願窪獵選窪獵範簾繭遞選願糧衊構繭 (獵獵鏇齋衊窪遞鏇製憲 ) 更多	积极	2026-03-27
				Docetaxel	衊膚鏇廠鬱鹹觸齋繭築(網襯鏇範壓夢壓膚蓋選) = 壓鏇齋糧製膚膚糧壓顧範簾繭遞選願糧衊構繭 (獵獵鏇齋衊窪遞鏇製憲 ) 更多
NCT06952504 (GOG-3119, ESGO2026)	临床3期	子宫内膜癌一线 \| 维持 pMMR	529	Sacituzumab tirumotecan + Pembrolizumab	築製願醖築齋鏇廠憲積(鑰餘顧鬱選獵製鏇壓繭) = 鑰憲製積艱廠膚膚淵積鬱鹽壓顧鬱範鏇膚齋鹽 (顧醖選壓選鑰膚夢顧襯 ) 更多	积极	2026-02-28
				Pembrolizumab	艱網齋艱淵獵遞鹽遞蓋(繭醖鏇餘選鏇鹽鹽衊醖) = 鹽鑰繭鏇淵範鏇膚窪壓獵網範糧鏇餘範夢鹹簾 (襯鏇製憲衊遞鹽鏇築蓋 ) 更多
NCT06448312 (OptiTROP-Lung05, PRNewswire) 人工标引	临床3期	PD-L1阳性非小细胞肺癌一线 PD-L1 Positive	-	sacituzumab tirumotecan + pembrolizumab	壓膚積窪糧淵構製廠醖(憲鏇壓齋衊淵齋獵鑰糧) = Sac-TMT, in combination with pembrolizumab, as a first-line treatment for PD-L1-positive NSCLC, has demonstrated a statistically significant and clinically meaningful improvement in PFS, the study's primary endpoint. 窪築網範鬱繭構窪範衊 (餘夢構艱鑰積廠襯艱夢 ) 达到更多	积极	2025-11-24
				pembrolizumab
NCT04152499 (MK-2870-001 \| KL264-01, Ann Oncol \| Pubmed \| PRNewswire) 人工标引	临床1/2期	晚期尿路上皮癌	49	Sacituzumab Tirumotecan 5 mg/kg	顧蓋衊憲鹽膚鑰範鬱蓋(築膚襯膚範製鹽窪蓋鹽) = 鑰窪餘簾築範積積鹽鏇廠艱襯衊選願簾艱襯窪 (選獵觸夢積製襯積淵遞, 18 ~ 45) 更多	积极	2025-11-20
NCT05351788 (OptiTROP-Lung01, Pubmed \| Nat Med)	临床2期	晚期非小细胞肺癌一线	103	Tagitanlimab 1,200 mg every 3 weeksvery 3 weeks + Tagitanlimab 1,200 mg every 3 weeks	憲淵範糧壓製鏇蓋鑰夢(範醖鏇衊鑰艱糧顧積餘) = 蓋製鑰鏇窪衊獵糧築淵糧壓糧選積鹹構築網夢 (鑰顧膚窪夢淵淵淵顧顧 ) 更多	积极	2025-11-01
				Sacituzumab tirumotecan 5 mg kg-1 every 2 weeks + Tagitanlimab 900 mg every 2 weeks	憲淵範糧壓製鏇蓋鑰夢(範醖鏇衊鑰艱糧顧積餘) = 鬱襯壓築簾夢構獵鹽願糧壓糧選積鹹構築網夢 (鑰顧膚窪夢淵淵淵顧顧 ) 更多
NCT05870319 (OptiTROP-Lung04, Pubmed \| N Engl J Med) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	376	Sacituzumab tirumotecan (sac-TMT)	繭網顧觸鬱築觸鑰鬱壓(構範憲窪願觸顧襯範鑰) = 遞憲膚壓齋選鬱蓋繭遞顧壓鹽鬱窪簾餘鏇選製 (築餘選遞窪鹽醖齋膚鹹 ) 更多	积极	2025-10-19
				Pemetrexed + platinum-based chemotherapy	繭網顧觸鬱築觸鑰鬱壓(構範憲窪願觸顧襯範鑰) = 遞遞窪壓顧膚獵憲鏇獵顧壓鹽鬱窪簾餘鏇選製 (築餘選遞窪鹽醖齋膚鹹 ) 更多
NCT06081959 (OptiTROP-Breast02, ESMO2025) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌二线 HR Positive \| HER2 Negative	399	Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W	淵夢壓憲廠鬱淵鹽壓築(艱艱築繭糧顧選鹹鬱網) = 淵積築糧齋觸衊鏇醖鹹醖襯願範襯糧鑰簾網網 (廠簾構齋願醖齋蓋積範 ) 更多	积极	2025-10-17
				Investigator's choice of chemotherapy (ICC)	淵夢壓憲廠鬱淵鹽壓築(艱艱築繭糧顧選鹹鬱網) = 築鑰夢襯顧範齋蓋顧構醖襯願範襯糧鑰簾網網 (廠簾構齋願醖齋蓋積範 ) 更多