Sacituzumab tirumotecan (also known as sac-TMT, SKB264, and MK-2870) is a human TROP2-directed antibody-drug conjugate developed for advanced solid tumors. Company disclosures indicate four approved and marketed indications in China and ongoing global Phase 3 studies outside Greater China. The payload is a belotecan-derivative topoisomerase I inhibitor released after TROP2-mediated internalization.
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
MSD said sacituzumab tirumotecan improved overall survival and progression-free survival in the Phase III TroFuse-005 trial in endometrial cancer. The study also met its objective response rate endpoint.
Blackstone closed its sixth dedicated life sciences fund at a $6.3 billion hard cap, the largest private fund raised for the sector. The vehicle is nearly 40% larger than its 2020 predecessor and targets late-stage drug assets.
The antibody-drug conjugate sacituzumab tirumotecan demonstrated significant survival benefits in pretreated EGFR-mutated NSCLC, with median overall survival of 20.0 months versus 13.5 months for docetaxel. The treatment also showed superior progression-free survival and objective response rates with a favorable safety profile compared to chemotherapy.
Sacituzumab tirumotecan demonstrated a median overall survival of 20.0 months versus 13.5 months with docetaxel in pretreated EGFR-mutated NSCLC patients. The phase 2 OptiTROP-Lung03 study showed a hazard ratio of 0.63 for overall survival benefit with the TROP2-directed antibody-drug conjugate.
Kelun-Biotech reported 2025 revenue of RMB2.06 billion with four products now marketed in China. The company's TROP2 ADC received multiple regulatory approvals for breast and lung cancer indications. A Phase 3 trial combining the ADC with pembrolizumab met its primary endpoint in first-line NSCLC treatment.
Merck announced multiple data presentations at the 2026 ASCO GU Cancers Symposium, including results from trials evaluating pembrolizumab combinations in muscle-invasive bladder cancer and renal cell carcinoma.
Merck is diversifying its oncology pipeline beyond Keytruda as the blockbuster approaches patent cliffs, focusing on immune modulating therapies, antibody-drug conjugates, and tumor intrinsic treatments through strategic acquisitions and partnerships.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07561463 |
Sacituzumab Tirumotecan for Pancreatic Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07548060 |
A Phase II Study of Sacituzumab Tirumotecan in Combination With Furmonertinib in Patients With Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy |
RECRUITING | PHASE2 |
| NCT07521670 |
Sacituzumab Tirumotecan in Recurrent/Metastatic Adenoid Cystic Carcinoma and Papillary Thyroid Carcinoma (STRAP) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07511023 |
Phase 2 Trial Of Sacituzumab Tirumotecan For Treatment Of Refractory Metastatic Or Unresectable Squamous Cell Carcinoma Of The Anus/Rectum |
NOT_YET_RECRUITING | PHASE2 |
| NCT07458113 |
Sac-TMT for Active TNBC Brain Metastases |
NOT_YET_RECRUITING | PHASE2 |
| NCT07438626 |
Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07419295 |
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) |
RECRUITING | PHASE3 |
| NCT07388875 |
Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC |
NOT_YET_RECRUITING | PHASE2 |
| NCT07343453 |
A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Second-Line and Subsequent Treatments for Advanced Thymic Epithelial Tumors |
NOT_YET_RECRUITING | PHASE2 |
| NCT07329322 |
Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer |
RECRUITING | PHASE2 |
