| Field | Value |
|---|---|
| Trial Name | EV-302 |
| DOI | https://doi.org/10.1056/NEJMoa2312117 |
| Diagnosis | Locally advanced or metastatic urothelial carcinoma, previously untreated. |
| Drugs | Enfortumab vedotin 1.25 mg/kg, Pembrolizumab 200 mg, Gemcitabine, Cisplatin or Carboplatin. |
| Line Of Therapy | First-line therapy |
| Regimen | Enfortumab vedotin (1.25 mg/kg IV on days 1 and 8) and Pembrolizumab (200 mg IV on day 1) every 3 weeks or Gemcitabine and either Cisplatin or Carboplatin every 3 weeks. |
| Primary End Point | Progression-free survival, Overall survival |
| Secondary End Point | |
| Competitor Arm | Gemcitabine and either Cisplatin or Carboplatin based on eligibility for Cisplatin. |
| Efficacy | Progression-free survival: 12.5 months (enfortumab vedotin-pembrolizumab) vs. 6.3 months (chemotherapy), Overall survival: 31.5 months (enfortumab vedotin-pembrolizumab) vs. 16.1 months (chemotherapy) |
| Response Types | |
| Time To Response | |
| Surveillance | |
| Subsets | |
| Adverse Events | Grade 3 or higher treatment-related adverse events: 55.9% (enfortumab vedotin-pembrolizumab group), 69.5% (chemotherapy group) |
| Others | NCT number: NCT04223856 |
| Conclusion | Enfortumab vedotin and pembrolizumab significantly improved progression-free survival and overall survival compared to chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma, with a manageable safety profile. |