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.
Eli Lilly's Retevmo met the primary endpoint in a Phase III lung cancer trial, Merck discontinued its TROP2 ADC MK-6837, and a Tango/Revolution combination showed benefit in pancreatic cancer.
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 |
|---|---|---|---|
| NCT07738341 |
GB268 Monotherapy or Combination Therapy for Locally Advanced/Metastatic Breast Cancer (Phase Ib/Ⅱ) |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07720258 |
Sacituzumab Tirumotecan (MK-2870) in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-Based Combination Therapy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07718854 |
Sacituzumab Tirumotecan +/- Pembrolizumab in I/O Exposed Metastatic or Recurrent Ovarian Clear Cell Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07703228 |
Second-Line Sacituzumab Tirumotecan Plus Anlotinib for Advanced Driver Gene-Negative Non-Squamous NSCLC |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07702305 |
Safety and Efficacy of Intrathecal Sacituzumab Tirumotecan for Leptomeningeal Metastasis in EGFR-TKI-Resistant Non-Small Cell Lung Cancer |
NOT_YET_RECRUITING | PHASE1 |
| NCT07662863 |
Sacituzumab Tirumotecan vs MMAE-ADCs in Advanced Urothelial Carcinoma (FUSCC-SPARE-UC-01) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07639086 |
Sacituzumab Tirumotecan in Pts w/ NEPC After Progression on Prior Chemotherapy |
NOT_YET_RECRUITING | PHASE2 |
| 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 |
