Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bevacizumab-Pfizer · 1 trial · 1 indication
ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
| Arm | Type | Description |
|---|---|---|
| Bevacizumab-Pfizer | EXPERIMENTAL | Bevacizumab-Pfizer plus paclitaxel and carboplatin |
| Bevacizumab-EU | ACTIVE_COMPARATOR | Bevacizumab-EU plus paclitaxel and carboplatin |
| Name | Type | Description |
|---|---|---|
| Bevacizumab-Pfizer | DRUG | Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy. |
| Bevacizumab-EU | DRUG | bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy. |
| Paclitaxel | DRUG | Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles. |
| Carboplatin | DRUG | carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles. |
Inclusion Criteria: * Male and female patients age at least 18 years of age, or age of consent in the region. * Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (N...
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Bevacizumab-Pfizer is being developed for the treatment of non-small cell lung cancer, specifically advanced non-squamous NSCLC. It is a monoclonal antibody studied in combination with paclitaxel and carboplatin chemotherapy in adult patients aged 18 years and older. It is an investigational product and has not been approved for this use.
Bevacizumab-Pfizer is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating this monoclonal antibody in oncology, including the Phase 3 study conducted across multiple countries worldwide.
Bevacizumab-Pfizer is in Phase 3 clinical development. Its single registered trial, NCT02364999, is a completed Phase 3 study, and no trials for this asset are currently listed as active. The drug remains investigational and has not been approved by the FDA for any indication.
Bevacizumab-Pfizer has been studied in one Phase 3 trial, NCT02364999, titled a comparative study of PF-06439535 plus paclitaxel-carboplatin and bevacizumab plus paclitaxel-carboplatin in patients with advanced non-squamous NSCLC. The trial enrolled 719 patients, was randomized, double-blind, and active-controlled, and is now completed.
Yes, bevacizumab-Pfizer is also known as PF-06439535, the internal code used by Pfizer during development. Both names refer to the same monoclonal antibody candidate studied in the Phase 3 NCT02364999 trial in advanced non-squamous non-small cell lung cancer.
NCT02364999 was a randomized, double-blind, active-controlled Phase 3 study comparing PF-06439535 plus paclitaxel-carboplatin against bevacizumab plus paclitaxel-carboplatin in patients with advanced non-squamous non-small cell lung cancer. It enrolled 719 patients aged 18 years and older across 28 countries, including the United States, Japan, Germany, and Brazil.