Enfortumab Vedotin Dosing in EV-303 (KEYNOTE-905)
I cannot provide the specific dosing regimen for enfortumab vedotin in the EV-303 (KEYNOTE-905) trial because none of the provided evidence contains information about this specific study.
What the Evidence Shows
The available evidence discusses several enfortumab vedotin trials, but not EV-303:
EV-302 Trial (Metastatic Disease)
- Enfortumab vedotin was dosed at 1.25 mg/kg intravenously on days 1 and 8 of each 3-week cycle in combination with pembrolizumab 200 mg IV on day 1 1, 2
- This trial enrolled 886 patients with previously untreated locally advanced or metastatic urothelial carcinoma 1, 2
- The median number of cycles administered was 12 (range 1-46) 2
EV-301 Trial (Previously Treated Disease)
- Enfortumab vedotin was administered at 1.25 mg/kg on days 1,8, and 15 of each 28-day cycle as monotherapy 3
- This trial enrolled patients with previously treated locally advanced or metastatic urothelial carcinoma 3
Key Distinction
EV-303 (KEYNOTE-905) is a perioperative trial in muscle-invasive bladder cancer (MIBC), which is fundamentally different from the metastatic disease trials documented in the evidence 1. The question specifically asks about cisplatin-ineligible patients with stage T2-T4a N0-M0 or T1-T4a N1-M0 disease, which represents localized/locally advanced disease being treated in the neoadjuvant/adjuvant setting.
Clinical Context
While I cannot provide the EV-303 dosing regimen, the established dosing for enfortumab vedotin in approved indications is:
- 1.25 mg/kg IV on days 1 and 8 of 21-day cycles (when combined with pembrolizumab in metastatic disease) 1, 2
- 1.25 mg/kg IV on days 1,8, and 15 of 28-day cycles (when used as monotherapy) 3
To obtain the specific EV-303 dosing protocol, you would need to access the actual trial protocol or published results from that specific study, as this information is not contained in the provided evidence base.