Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VB4-845, Oportuzumab monatox
Vicinium · 2 trials · 4 indications
Complete response rate at 3 months in patients with CIS with or without resected papillary disease following initiation of Vicinium therapy. This is the percentage of patients who were free of high-grade disease at the post-induction (3 month) assessment timepoint. A patient was considered to have a complete response if the urine cytology was reported as negative or atypical AND the cystoscopy was reported as normal or any suspicious areas were deemed negative for high-grade disease upon biopsy assessment.
Duration of complete response in participants with CIS with or without resected papillary disease who achieved a complete response at the post-induction (3 month) assessment. This is the number of days from the date of first occurrence of complete response to the date of documented treatment failure or death, whichever occurs first
Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment
| Arm | Type | Description |
|---|---|---|
| Vicinium | EXPERIMENTAL | Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks. |
| Treatment Schedule A - | ACTIVE_COMPARATOR | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy. If the subject had histologically confirmed disease that is stage \<T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study \[EOS\]). |
| Treatment Schedule B | ACTIVE_COMPARATOR | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy. If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS). |
| Name | Type | Description |
|---|---|---|
| Vicinium | BIOLOGICAL | Intravesical administration |
Inclusion Criteria: 1. Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder as follows: 1. CIS (with or without papillary disease) OR 2. Any grade T1 papillary disease OR 3. High-grade Ta papillary disease based on a biopsy within ...
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Vicinium is being developed for the treatment of bladder cancer, including non-muscle invasive bladder cancer and urinary bladder cancer. It is specifically studied in patients with non-muscle invasive bladder cancer who have been previously treated with BCG. It is an investigational therapy and has not been approved by the FDA.
Vicinium is being developed by Carisma Therapeutics, Inc., which trades under the ticker symbol CARM. The company is responsible for the clinical development of the drug.
Vicinium is in Phase 3 clinical development. A Phase 3 trial has been completed, and the drug remains investigational. It has not been approved by the FDA for any indication.
Vicinium has been studied in two completed clinical trials. The Phase 3 trial, NCT02449239, evaluated Vicinium in patients with non-muscle invasive bladder cancer previously treated with BCG and enrolled 133 patients. The Phase 2 trial, NCT00462488, studied Vicinium in patients with non-invasive urothelial carcinoma in situ and enrolled 46 patients.
Vicinium is a monoclonal antibody. No molecular target or target class information is available for this drug.