Table 1.
Summary of Clinical Trials
| Trial | Objective | Patient Population | Key Findings |
|---|---|---|---|
|
EV-101 n= 112 |
Phase I study evaluating safety and efficacy | Patients with metastatic urothelial carcinoma (mUC) | Objective Response Rate = 42% Common ADRs: decreased appetite, weakness, alopecia |
|
EV-201 n= 125 |
Safety and efficacy evaluation | Locally advanced or metastatic urothelial carcinoma | Objective Response rate = 44% Common ADRs: fatigue, baldness, reduced appetite, dysgeusia, peripheral sensory neuropathy |
|
EV-301 n= 608 |
Overall survival comparison | Locally advanced or metastatic urothelial cancer | Longer median overall survival in the enfortumab vedotin group compared to the chemotherapy group |
|
NCT03070990 n= 26 |
Safety and pharmacokinetics evaluation | Japanese patients with urothelial carcinoma | Objective response rate: 35.3% |
| EV-302 | Comparison of enfortumab vedotin + pembrolizumab | Locally advanced or metastatic urothelial carcinoma | Ongoing trial |
| MK-3475-905/KEYNOTE-905/EV-303 | Effectiveness of pembrolizumab or enfortumab vedotin combination | Muscle-invasive bladder cancer (MIBC) | Ongoing trial |
| MORPHEUS mUC | Evaluation of pembrolizumab or enfortumab vedotin combination | Muscle-invasive bladder cancer (MIBC) | Ongoing trial |
Abbreviations: ADRs, Adverse Reactions; mUC, Patients with metastatic urothelial carcinoma (mUC); MIBC, Muscle-invasive bladder cancer.