Table of contents

• Trial overview
• Breast cancer studies
• Bladder and urothelial cancer studies
• Lung cancer studies
• Other cancer studies
• Key endpoints and patient groups
• Safety and biomarker studies

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.^[1] The trials range from Phase 1 to Phase 3 and include both completed and authorised studies.^[1]

Most studies focus on advanced, metastatic, or high-risk cancers, but some also study treatment before surgery or after surgery in earlier disease.^[1] Many trials compare Sacituzumab Govitecan with standard care or combine it with other treatments such as pembrolizumab, zimberelimab, domvanalimab, bevacizumab, or platinum chemotherapy.^[1]

Breast cancer studies

Breast cancer is the largest group of studies in the source data.^[1] 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.^[1]

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.^[1] 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.^[1]

Some breast cancer trials test combinations rather than Sacituzumab Govitecan alone.^[1] 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.^[1]

Other studies look at treatment tolerance and side effects in a practical way.^[1] 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.^[1]

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.^[1] These studies often explore bladder-preserving approaches, meaning treatment is aimed at keeping the bladder in place when possible.^[1]

In bladder cancer, the main outcomes include pathological complete response, clinical complete response, and disease-free or event-free survival.^[1] 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.^[1]

Urothelial cancer studies also compare Sacituzumab Govitecan with treatment of physician’s choice in locally advanced or metastatic disease.^[1] 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.^[1]

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.^[1]

Lung cancer studies

Lung cancer trials cover both non-small cell lung cancer and extensive-stage small cell lung cancer.^[1] The studies include people with active brain metastases, resectable disease after surgery, advanced disease, and first-line treatment settings.^[1]

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.^[1] Another Phase 2 study looks at neoadjuvant treatment before surgery in resectable non-small cell lung cancer and measures pathological complete response.^[1]

Phase 3 trials compare Sacituzumab Govitecan with docetaxel or with treatment of physician’s choice in advanced or metastatic non-small cell lung cancer.^[1] 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.^[1]

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.^[1] These studies show that researchers are testing Sacituzumab Govitecan across different tumor types, not just one cancer.^[1]

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.^[1] The Phase 1/2 esophagogastric study measures overall response rate in metastatic disease.^[1]

In thyroid cancer, the study includes two groups: advanced radioactive-iodine refractory differentiated thyroid carcinoma and advanced anaplastic thyroid carcinoma.^[1] 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.^[1]

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.^[1] Other common endpoints are progression-free survival, overall survival, disease-free survival, event-free survival, and pathological complete response.^[1]

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.^[1] Some studies also use special cancer-specific measures such as RANO-BM for brain metastases and CelTIL score in breast cancer biomarker research.^[1]

Patient groups vary widely, but common patterns are clear.^[1] 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.^[1]

Safety and biomarker studies

Some trials are not only about tumor shrinkage but also about safety and tolerability.^[1] For example, the long-term safety study in metastatic solid tumors measures adverse events, serious adverse events, and laboratory abnormalities.^[1]

The biomarker study in metastatic breast cancer looks at change in CelTIL score between baseline and early treatment samples.^[1] 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.^[1]

Other studies also measure treatment tolerance, such as diarrhea and neutropenia, to better understand how patients handle Sacituzumab Govitecan in real trial settings.^[1]