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 being studied for the treatment of follicular lymphoma and rheumatoid arthritis. It is developed by Pfizer, Inc. and is currently in Phase 3 clinical development for these indications.
PF-05280586 targets CD20, a protein found on the surface of B cells. By binding to CD20, it is designed to deplete B cells, which are involved in the pathology of follicular lymphoma and rheumatoid arthritis.
PF-05280586 is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is being studied as a potential treatment for follicular lymphoma and rheumatoid arthritis.
PF-05280586 is in Phase 3 clinical development. It has completed a Phase 3 trial in follicular lymphoma and a Phase 2 trial in rheumatoid arthritis. The drug is investigational and has not been approved by regulatory authorities.
PF-05280586 has been studied in two completed trials. NCT01526057 was a Phase 2 study in rheumatoid arthritis with 220 participants. NCT02213263 was a Phase 3 study in follicular lymphoma with 394 participants. Both trials are completed.
PF-05280586 is a biosimilar candidate to rituximab, a reference monoclonal antibody. In clinical trials, it was compared directly to rituximab to assess pharmacokinetic and pharmacodynamic similarity, as well as efficacy and safety in patients with rheumatoid arthritis and follicular lymphoma.