Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-05280014 · 4 trials · 3 indications
The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) \>20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.
ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size \[short axis \<10 mm\]) or partial response (PR, \>=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.
| Arm | Type | Description |
|---|---|---|
| PF-05280014 | EXPERIMENTAL | - |
| Herceptin® | ACTIVE_COMPARATOR | - |
| Trastuzumab-US | ACTIVE_COMPARATOR | - |
| A | EXPERIMENTAL | PF-05280014 |
| B | ACTIVE_COMPARATOR | Trastuzumab-EU |
| C | ACTIVE_COMPARATOR | Trastuzumab-US |
| Name | Type | Description |
|---|---|---|
| PF-05280014 | BIOLOGICAL | Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles. |
| Taxotere® | DRUG | Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles. |
| Paraplatin® | DRUG | Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles. |
| Trastuzumab-EU | BIOLOGICAL | Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles. |
| Paclitaxel | DRUG | A nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel. The starting dose of paclitaxel will be 80 mg/m\^2 by IV infusion over 60 minutes (duration of infusion may be modified according to local standard of care, if applicable). Provision is made for dose reduction to 70 mg/m\^2 and then 60 mg/m\^2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained, in the judgment of the investigator. |
| Herceptin® | BIOLOGICAL | Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion weekly until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the Herceptin® regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability. |
| Herceptin | BIOLOGICAL | Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1 |
Inclusion Criteria: * Histologically confirmed HER2 overexpressing invasive breast cancer. * Plan for definitive surgical resection of breast tumor (i.e., lumpectomy or mastectomy, and sentinel node (SN) biopsy or axillary lymph node dissection (ALND). * Plan for neoadjuvant chemotherapy. * Measura...
PF-05280014 is an investigational monoclonal antibody being studied for use in metastatic breast cancer, early breast cancer, and in healthy volunteers. It is developed by Pfizer, Inc. (PFE) as a potential biosimilar to trastuzumab, and has completed Phase 3 clinical trials in these oncology indications.
PF-05280014 is a monoclonal antibody that targets HER2, a protein found on the surface of some breast cancer cells. By binding to HER2, it is designed to interfere with cancer cell growth signals. This mechanism is being evaluated in HER2-positive breast cancer settings.
PF-05280014 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company has conducted clinical trials to evaluate this investigational drug as a potential trastuzumab biosimilar.
PF-05280014 has completed Phase 3 clinical trials, which are the final stage of testing before potential regulatory submission. However, it remains an investigational drug and is not yet approved by regulatory authorities. Pfizer has completed all trials listed for this asset.
PF-05280014 has been studied in several completed trials. NCT01989676 was a Phase 3 study in HER2-positive first-line metastatic breast cancer. NCT02187744 was a Phase 3 neoadjuvant study in early breast cancer. NCT01603264 and NCT02015156 were Phase 1 pharmacokinetic studies in healthy male volunteers.
PF-05280014 is being developed as a potential biosimilar to trastuzumab, the reference product. Clinical trials have compared PF-05280014 directly against trastuzumab in healthy volunteers and in breast cancer patients to assess similarity in pharmacokinetics, efficacy, and safety.