Also known as: Trodelvy
Sacituzumab govitecan-hziy is marketed as TRODELVY, a Trop-2-directed antibody-drug conjugate used in pretreated unresectable locally advanced or metastatic triple-negative breast cancer and HR-positive/HER2-negative metastatic breast cancer. It delivers the topoisomerase I inhibitor SN-38 to Trop-2-expressing tumor cells after internalization. U.S. initial approval was in 2020.
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.
The ASCENT-04 trial shows Trodelvy plus Keytruda extends progression-free survival by 3.4 months in PD-L1-positive metastatic triple-negative breast cancer. Meanwhile, the ToPCourT trial investigates trilaciclib combined with pembrolizumab and chemotherapy for advanced TNBC. These developments signal evolving treatment approaches for this aggressive breast cancer subtype.
New antibody-based approaches demonstrate clinical benefits across multiple cancer types, including improved survival in triple-negative breast cancer, enhanced tumor detection via PET imaging, and activity in relapsed mantle cell lymphoma.
The ASCENT-04 trial showed sacituzumab govitecan plus pembrolizumab improved progression-free survival in PD-L1-positive TNBC without increased toxicity. Meanwhile, experts debate whether ADCs function as targeted therapy or advanced chemotherapy, with sequencing questions remaining unresolved.
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.
IDEAYA Biosciences announced Q4 2025 financial results with $1.05 billion in cash reserves and confirmed 130 progression-free survival events in its Phase 2/3 OptimUM-02 trial of darovasertib for metastatic uveal melanoma, with topline results expected by late March 2026.
Edgewise Therapeutics and IDEAYA Biosciences released annual financial reports detailing clinical trial progress and strategic initiatives. Both companies are advancing multiple clinical-stage programs while managing significant operating expenses.
Antibody-drug conjugates targeting TROP2 with topoisomerase I inhibitor payloads are currently marketed in breast and lung cancer, with over 100 such ADCs now in clinical trials for various malignancies including gastrointestinal tumors.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07582887 |
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response |
RECRUITING | |
| NCT07504588 |
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07492914 |
Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma |
RECRUITING | PHASE2 |
| NCT07461454 |
YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT07393555 |
Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07368543 |
Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07339059 |
Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer |
RECRUITING | PHASE2 |
| NCT07328490 |
Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer |
WITHDRAWN | PHASE1/PHASE2 |
| NCT07178730 |
NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT07063212 |
A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC) |
RECRUITING | PHASE2 |
