# Sacituzumab tirumotecan

Source: https://onco.cc/drugs/sacituzumab-tirumotecan/  
OnCo record `sacituzumab-tirumotecan` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Sacituzumab tirumotecan is Kelun-Biotech's TROP2 ADC, approved in China in 2024 for pretreated triple-negative breast cancer and then EGFR-mutant lung cancer. Merck holds rights outside Greater China and runs the TroFuse programme of more than ten phase 3 trials across breast, lung, endometrial and cervical cancer; in the US it holds a priority voucher but no approval yet.

## Summary

Kelun-Biotech's sac-TMT was approved by China's NMPA in 2024 for pretreated TNBC (the first TROP2 ADC approval in China) and later for EGFR-mutant NSCLC. Merck holds ex-Greater-China rights and runs the TroFuse programme of >10 phase 3 trials, including first-line TNBC (positive on primary endpoint per 2026 reports), HR+ breast, NSCLC, endometrial, and cervical cancer, many combined with pembrolizumab. FDA Breakthrough Therapy designation (EGFR-mutant NSCLC, 2024) and a Commissioner's National Priority Voucher (July 2026).

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Code: sac-TMT, MK-2870, SKB264
- Modality: ADC
- Mechanism: Anti-TROP2 IgG1 with a stable, irreversibly-conjugated linker and a belotecan-derived TOP1 payload with reported lower efflux-pump susceptibility.
- Payload: T030 (belotecan-derived TOP1 inhibitor), DAR ~7.4
- Linker: Sulfonyl pyrimidine (CL2A-like), pH-sensitive and enzyme-cleavable
- Approvals: China 2024: Pretreated advanced TNBC; later EGFR-mutant NSCLC after TKI
- Dosing: IV infusion; 5 mg/kg every 2 weeks (China label, TNBC); phase 3 trials use 4 mg/kg every 2 weeks in combination regimens

## Sources

- Frontiers review (2026): https://www.frontiersin.org/journals/oncology-reviews/articles/10.3389/or.2026.1781533/full

## Connected records

- cancers: [Advanced or recurrent endometrial cancer](https://onco.cc/cancers/advanced-recurrent-endometrial-cancer/), [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Cervical cancer](https://onco.cc/cancers/cervical/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Endometrial cancer with no specific molecular profile](https://onco.cc/cancers/endometrial-nsmp/), [HER2-low and HER2-ultralow metastatic breast cancer](https://onco.cc/cancers/her2-low-metastatic-breast-cancer/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [p53-abnormal endometrial cancer, including uterine serous carcinoma](https://onco.cc/cancers/endometrial-p53-abnormal/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/), [Recurrent or metastatic cervical cancer](https://onco.cc/cancers/recurrent-metastatic-cervical-cancer/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/), [TROP2 PET](https://onco.cc/technologies/trop2-pet/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/), [Sichuan Kelun-Biotech](https://onco.cc/companies/kelun-biotech/)
- terms: [Breakthrough Therapy / Priority Review / Priority Voucher](https://onco.cc/terms/breakthrough-designation/), [Hydrophilic next-generation linkers (TMALIN, Dolaflexin, sulfonyl-pyrimidine, PEG-containing)](https://onco.cc/terms/hydrophilic-next-gen/), [T030 (belotecan derivative)](https://onco.cc/terms/t030/), [Topoisomerase-I inhibitor payloads](https://onco.cc/terms/topoisomerase-i-payloads/)
- trials: [A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)](https://onco.cc/trials/nct07286149/), [A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)](https://onco.cc/trials/nct06428409/), [A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Canc](https://onco.cc/trials/nct07216703/), [A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)](https://onco.cc/trials/nct06637423/), [A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)](https://onco.cc/trials/nct06966700/), [A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)](https://onco.cc/trials/nct07318558/), [A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)](https://onco.cc/trials/nct07419295/), [A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.](https://onco.cc/trials/nct07729033/), [A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients](https://onco.cc/trials/nct05870319/), [A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Ca](https://onco.cc/trials/nct07054242/), [A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)](https://onco.cc/trials/nct06483334/), [A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)](https://onco.cc/trials/nct06312176/), [A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)](https://onco.cc/trials/nct06841354/), [A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-](https://onco.cc/trials/nct05816252/), [A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advan](https://onco.cc/trials/nct06670196/), [A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative P](https://onco.cc/trials/nct06711900/), [A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer](https://onco.cc/trials/nct06448312/), [A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Sm](https://onco.cc/trials/nct06312137/), [A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participan](https://onco.cc/trials/nct06952504/), [A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With](https://onco.cc/trials/nct06459180/), [A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)](https://onco.cc/trials/nct05319730/), [A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)](https://onco.cc/trials/nct06356311/), [A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Pl](https://onco.cc/trials/nct06824467/), [Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis](https://onco.cc/trials/nct07545213/), [Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma](https://onco.cc/trials/nct07105852/), [HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer](https://onco.cc/trials/nct06849492/), [KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)](https://onco.cc/trials/nct07252739/), [Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer](https://onco.cc/trials/nct07371208/), [Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)](https://onco.cc/trials/nct06788912/), [Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-287](https://onco.cc/trials/nct06422143/), [Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)](https://onco.cc/trials/nct04152499/), [Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Facto](https://onco.cc/trials/nct07329322/), [Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases](https://onco.cc/trials/nct07623577/), [Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC](https://onco.cc/trials/nct07244874/), [Sac-TMT for Active TNBC Brain Metastases](https://onco.cc/trials/nct07458113/), [Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations](https://onco.cc/trials/nct07628504/), [Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With P](https://onco.cc/trials/nct06170788/), [Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)](https://onco.cc/trials/nct06132958/), [Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)](https://onco.cc/trials/nct06393374/), [Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With](https://onco.cc/trials/nct06074588/), [Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, A](https://onco.cc/trials/nct06305754/), [Sacituzumab Tirumotecan for Pancreatic Cancer](https://onco.cc/trials/nct07561463/), [Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)](https://onco.cc/trials/nct07501169/), [Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC](https://onco.cc/trials/nct07007780/), [Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma](https://onco.cc/trials/nct07324629/), [Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer](https://onco.cc/trials/nct07701122/), [Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer](https://onco.cc/trials/nct07139470/), [Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer](https://onco.cc/trials/nct07153965/), [Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases](https://onco.cc/trials/nct07343479/), [SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.](https://onco.cc/trials/nct05351788/), [Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)](https://onco.cc/trials/nct06469944/), [Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)](https://onco.cc/trials/nct06445972/), [Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)](https://onco.cc/trials/nct06780111/), [Toripalimab Plus Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable NSCLC](https://onco.cc/trials/nct07819578/)
- institutions: [Cancer Hospital, Chinese Academy of Medical Sciences](https://onco.cc/institutions/cams-cancer-hospital/)
- pairings: [TROP2 PET → TROP2 ADC selection](https://onco.cc/pairings/trop2-pet-to-adc/)
- roadmaps: [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/), [TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET](https://onco.cc/roadmaps/trop2-adc-roadmap/)
- ideas: [Efflux-agnostic therapy for mesenchymal TNBC](https://onco.cc/ideas/idea-efflux-agnostic/), [TROP2 PET to choose and sequence TROP2 ADCs](https://onco.cc/ideas/idea-trop2-pet-selection/)
- people: [Binghe Xu](https://onco.cc/people/xu-binghe/), [Xichun Hu](https://onco.cc/people/hu-xichun/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/)
- pathways: [Drug efflux pumps (ABC transporters)](https://onco.cc/pathways/drug-efflux-pumps/)
- biomarkers: [TROP2 expression](https://onco.cc/biomarkers/trop2-expression/)

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