In short
Sacituzumab Govitecan is being studied in many clinical trials for different cancers. These studies look at how well it works, how safe it is, and which patients may benefit most, including people with breast cancer, bladder cancer, lung cancer, thyroid cancer, endometrial cancer, and other solid tumors.
Key points
- Sacituzumab Govitecan is being studied in a wide range of cancers, especially breast cancer, bladder cancer, lung cancer, urothelial cancer, thyroid cancer, endometrial cancer, and other solid tumors. The trials include Phase 1, Phase 2, and Phase 3 studies, with many larger Phase 3 trials comparing it with standard treatment. Some studies focus on advanced or metastatic disease, while others look at earlier settings such as neoadjuvant or perioperative treatment before or around surgery. The main goals are to see whether it improves response rates, survival, disease control, and complete response after treatment. Several trials also study special combinations with other medicines and include patients who cannot receive cisplatin-based chemotherapy or who have already had prior treatment. Safety and tolerability are also important parts of the research.
Trial overview
The trial data show that Sacituzumab Govitecan is being tested in many interventional studies, meaning patients receive a study treatment so researchers can measure the results. The trials range from Phase 1 to Phase 3 and include both completed and authorised studies.
Most studies focus on advanced, metastatic, or high-risk cancers, but some also study treatment before surgery or after surgery in earlier disease. Many trials compare Sacituzumab Govitecan with standard care or combine it with other treatments such as pembrolizumab, zimberelimab, domvanalimab, bevacizumab, or platinum chemotherapy.
Breast cancer studies
Breast cancer is the largest group of studies in the source data. Trials include triple-negative breast cancer, HR+/HER2-negative breast cancer, HER2-low triple-negative breast cancer, and early breast cancer with a high risk of relapse.
Several Phase 3 trials compare Sacituzumab Govitecan with treatment of physician’s choice, often using progression-free survival or invasive disease-free survival as the main outcome. Examples include studies in HR+/HER2− metastatic breast cancer after endocrine therapy, PD-L1 positive metastatic triple-negative breast cancer, and patients with residual invasive disease after surgery and neoadjuvant therapy.
Some breast cancer trials test combinations rather than Sacituzumab Govitecan alone. For example, one study tests Sacituzumab Govitecan plus pembrolizumab in low-risk early triple-negative breast cancer, while another tests alternating combinations with trastuzumab deruxtecan in HER2-low triple-negative breast cancer.
Other studies look at treatment tolerance and side effects in a practical way. The PRIMED study measures diarrhea and neutropenia, and the SATROPIN study looks at diarrhea during the first two treatment cycles in advanced TNBC or HR(+)/HER2(–) breast cancer.
Bladder and urothelial cancer studies
Several trials study muscle-invasive bladder cancer and urothelial cancer, including patients who cannot receive cisplatin-based chemotherapy or who refuse cystectomy, which is bladder removal surgery. These studies often explore bladder-preserving approaches, meaning treatment is aimed at keeping the bladder in place when possible.
In bladder cancer, the main outcomes include pathological complete response, clinical complete response, and disease-free or event-free survival. The preSAVE, SURE-02, and perioperative immunotherapy studies all focus on patients with muscle-invasive bladder cancer who are unfit for or unwilling to receive cisplatin-based treatment.
Urothelial cancer studies also compare Sacituzumab Govitecan with treatment of physician’s choice in locally advanced or metastatic disease. One Phase 3 study uses overall survival as the main endpoint, while a Phase 2 study measures objective response rate and progression-free survival across different cohorts.
There is also a Phase 2 study in non-muscle invasive bladder cancer that tests Sacituzumab Govitecan with sasanlimab and measures complete response of high-grade disease at 3 months.
Lung cancer studies
Lung cancer trials cover both non-small cell lung cancer and extensive-stage small cell lung cancer. The studies include people with active brain metastases, resectable disease after surgery, advanced disease, and first-line treatment settings.
In one Phase 2 study, Sacituzumab Govitecan is combined with bevacizumab for brain metastases from non-small cell lung cancer, and the main endpoint is brain objective response rate using RANO-BM criteria. Another Phase 2 study looks at neoadjuvant treatment before surgery in resectable non-small cell lung cancer and measures pathological complete response.
Phase 3 trials compare Sacituzumab Govitecan with docetaxel or with treatment of physician’s choice in advanced or metastatic non-small cell lung cancer. A Phase 3 study in extensive-stage small cell lung cancer compares Sacituzumab Govitecan with standard care and measures objective response rate and overall survival.
Other cancer studies
Beyond breast, bladder, and lung cancer, the source data include studies in metastatic solid tumors, metastatic esophagogastric adenocarcinoma, thyroid cancer, and endometrial cancer. These studies show that researchers are testing Sacituzumab Govitecan across different tumor types, not just one cancer.
A Phase 2 study in metastatic solid tumors measures objective response rate, and a Phase 3 long-term safety study follows patients who are already benefiting from treatment. The Phase 1/2 esophagogastric study measures overall response rate in metastatic disease.
In thyroid cancer, the study includes two groups: advanced radioactive-iodine refractory differentiated thyroid carcinoma and advanced anaplastic thyroid carcinoma. In endometrial cancer, the Phase 3 study compares Sacituzumab Govitecan with treatment of physician’s choice and measures progression-free survival, overall survival, objective response rate, and physical function.
Key endpoints and patient groups
The most common endpoint is objective response rate, which shows how many patients had tumor shrinkage by standard imaging rules. Other common endpoints are progression-free survival, overall survival, disease-free survival, event-free survival, and pathological complete response.
Many trials use RECIST 1.1, a standard method for measuring tumor change on scans, and some use BICR, where outside reviewers check the scans without knowing which treatment was given. Some studies also use special cancer-specific measures such as RANO-BM for brain metastases and CelTIL score in breast cancer biomarker research.
Patient groups vary widely, but common patterns are clear. Many studies include adults with metastatic or locally advanced disease, while others focus on people after surgery, people with high relapse risk, or people who cannot receive cisplatin-based chemotherapy.
Safety and biomarker studies
Some trials are not only about tumor shrinkage but also about safety and tolerability. For example, the long-term safety study in metastatic solid tumors measures adverse events, serious adverse events, and laboratory abnormalities.
The biomarker study in metastatic breast cancer looks at change in CelTIL score between baseline and early treatment samples. This score combines tumor cellularity and tumor-infiltrating lymphocytes, which are immune cells found inside the tumor, and it is used here as a surrogate of treatment response after one dose.
Other studies also measure treatment tolerance, such as diarrhea and neutropenia, to better understand how patients handle Sacituzumab Govitecan in real trial settings.