Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
interferon alfa-2a · 3 trials · 1 indication
Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.
PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.
| Arm | Type | Description |
|---|---|---|
| Bevacizumab + IFN-Alfa-2A | EXPERIMENTAL | Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity. |
| Placebo + IFN-Alfa-2A | PLACEBO_COMPARATOR | Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity. |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bevacizumab [Avastin] | DRUG | 10 mg/kg IV every 2 weeks |
| Interferon alfa 2a [Roferon] | DRUG | 9 MIU SC 3 times/week |
| Placebo | DRUG | IV every 2 weeks |
| interferon alfa-2a | DRUG | 3 MIU sc t.i.w. |
| Vinblastine | DRUG | 0.1mg/kg iv every 3 weeks |
Inclusion Criteria: * metastatic renal cell cancer (clear cell type); * nephrectomy; * absence of proteinuria. Exclusion Criteria: * prior systemic treatment for metastatic renal cell cancer; * major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study tre...
Interferon alfa-2a is used for the treatment of renal cell cancer, specifically in combination with bevacizumab (Avastin) in metastatic renal cell cancer. It is being studied in Phase 3 clinical trials as part of combination therapy for this indication.
Interferon alfa-2a is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials of the drug in combination with bevacizumab for renal cell cancer.
Interferon alfa-2a is in Phase 3 clinical development for renal cell cancer. It is an investigational drug and has not been approved by regulatory authorities. Three clinical trials have been completed, including one Phase 3 study.
Interferon alfa-2a has been studied in three completed clinical trials for renal cell cancer. These include NCT00520403, a Phase 2 study with 25 patients; NCT00738530, a Phase 3 study with 649 patients; and NCT00796757, a Phase 2 study with 146 patients.
Interferon alfa-2a is also known as Roferon. In clinical trials, it is studied under the name Roferon, such as in the Phase 3 study NCT00738530, which evaluates Avastin added to Roferon therapy in patients with metastatic renal cell cancer.