Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-08046054 · 2 trials · 11 indications
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| PF-08046054 monotherapy | EXPERIMENTAL | PF-08046054 monotherapy |
| Docetaxel monotherapy | ACTIVE_COMPARATOR | Docetaxel monotherapy |
| PF-08046054 Combination Therapy | EXPERIMENTAL | PF-08046054 + pembrolizumab |
| Name | Type | Description |
|---|---|---|
| PF-08046054 | DRUG | Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion. |
| Docetaxel monotherapy | DRUG | Participants will receive Docetaxel, administered as an IV infusion. |
| pembrolizumab | DRUG | 200 mg once every 3 weeks given into the vein (IV; intravenously) |
Inclusion Criteria * Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual,...
PF-08046054 is being studied for the treatment of non-small cell lung cancer, including metastatic non-small cell lung carcinoma. It is also being evaluated in a range of advanced solid tumors, such as squamous cell carcinoma of the head and neck, esophageal squamous cell carcinoma, triple negative breast cancer, gastric cancer, endometrial cancer, pancreatic adenocarcinoma, and hepatocellular carcinoma.
PF-08046054 targets PD-L1, also known as programmed cell death ligand 1. PD-L1 is a protein that tumor cells use to suppress immune responses. By binding to PD-L1, PF-08046054 is designed to interfere with that immune evasion pathway in PD-L1 positive tumors, including non-small cell lung cancer.
PF-08046054 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The agent is also referred to as PF-08046054/SGN-PDL1V, reflecting its development history. Pfizer is running the clinical program in oncology, with studies enrolling patients across North America, Europe, Asia, and other regions.
PF-08046054 is in clinical development and is not approved. It is being tested in a Phase 1 study in advanced solid tumors and a Phase 3 study in previously treated PD-L1 positive non-small cell lung cancer. The Phase 3 trial compares PF-08046054/SGN-PDL1V with docetaxel in adult participants.
PF-08046054 is being evaluated in two registered studies. NCT05208762 is a Phase 1 trial in advanced solid tumors that is recruiting, with enrollment of 714 participants. NCT07144280 is a Phase 3 trial comparing PF-08046054/SGN-PDL1V with docetaxel in previously treated PD-L1 positive non-small cell lung cancer, with enrollment of 680 participants.
Yes, PF-08046054 and SGN-PDL1V refer to the same investigational agent, which is often written as PF-08046054/SGN-PDL1V. The dual name reflects the compound's development history. Both names appear in the registered clinical trials, including the Phase 1 advanced solid tumor study and the Phase 3 non-small cell lung cancer study.