Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-05280586 · 2 trials · 2 indications
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.
Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered.
The AUC 0-inf refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) extrapolated to infinity.
| Arm | Type | Description |
|---|---|---|
| PF-05280586 | EXPERIMENTAL | - |
| MabThera® | ACTIVE_COMPARATOR | - |
| A - PF-05280586 | EXPERIMENTAL | - |
| B - Rituximab EU | ACTIVE_COMPARATOR | - |
| C- Rituximab-US | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-05280586 | BIOLOGICAL | PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22 |
| MabThera® | BIOLOGICAL | MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22 |
| MabThera | BIOLOGICAL | 1000 mg, IV on days 1 and 15 |
| Rituxan | BIOLOGICAL | 1000 mg, IV on days 1 and 15 |
Inclusion Criteria: * Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma * Ann Arbor Stage II, III, or IV Exclusion Criteria: * Not a candidate for treatment with rituximab as a single-agent * Evidence of transformation to a high grade or diffuse large B-cell lymphoma * An...
PF-05280586 is an investigational monoclonal antibody developed by Pfizer, Inc. (ticker: PFE). It is being studied as a proposed biosimilar to rituximab, with clinical development in follicular lymphoma and rheumatoid arthritis. The program has completed a Phase 3 trial in follicular lymphoma and a Phase 2 trial in rheumatoid arthritis.
PF-05280586 has been studied for the first-line treatment of CD20-positive, low tumor burden follicular lymphoma and for active rheumatoid arthritis in patients with an inadequate response to TNF inhibitors. These are the two indications evaluated in its completed clinical trials.
PF-05280586 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program, including the Phase 3 REFLECTIONS B328-06 trial in follicular lymphoma and the Phase 2 REFLECTIONS B328-01 trial in rheumatoid arthritis.
PF-05280586 has completed a Phase 3 clinical trial in follicular lymphoma and a Phase 2 trial in rheumatoid arthritis. It is an investigational product and has not been approved by the FDA for any indication.
PF-05280586 has been evaluated in two completed trials: NCT02213263, a Phase 3 study in first-line CD20-positive, low tumor burden follicular lymphoma with 394 patients, and NCT01526057, a Phase 2 pharmacokinetic and pharmacodynamic study in active rheumatoid arthritis with 220 patients.
PF-05280586 is also known as rituximab-Pfizer. It is a proposed biosimilar to rituximab, referencing MabThera (rituximab-EU) as the comparator in its Phase 3 trial. It is not the same as the originator rituximab product but is intended to be a biosimilar version.