Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vinflunine · 1 trial · 1 indication
OS was defined as time from randomization to death from any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A: Atezolizumab | EXPERIMENTAL | Atezolizumab will be administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants will receive atezolizumab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator. |
| Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | ACTIVE_COMPARATOR | Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody | DRUG | Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. |
| Docetaxel | DRUG | Docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle. |
| Paclitaxel | DRUG | Paclitaxel 175 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle. |
| Vinflunine | DRUG | Vinflunine 320 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle. |
Inclusion Criteria: * Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra). * Representative tumor specimens as specified by the protocol * Disease progression during or following treatment with at least one pl...
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Vinflunine is an investigational small molecule being studied for the treatment of bladder cancer. It is currently in Phase 3 clinical development. Vinflunine is not approved and remains under investigation for this indication.
Vinflunine is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this small molecule for the treatment of bladder cancer.
Vinflunine is in Phase 3 clinical development for bladder cancer. It is an investigational drug and has not been approved. One Phase 3 trial has been completed, with a total enrollment of 931 participants.
Vinflunine was studied in the completed Phase 3 trial NCT02302807, titled 'A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]'. This trial enrolled 931 participants across multiple countries.
No, Vinflunine is not the same as Atezolizumab. Vinflunine is a small molecule, while Atezolizumab is a different drug. In the clinical trial NCT02302807, Vinflunine was used as a chemotherapy comparator against Atezolizumab.