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Also known as SGN-PDL1V
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 an investigational oncology therapy being studied in non-small cell lung cancer and other advanced solid tumors. Its lead development program is in previously treated PD-L1 positive metastatic non-small cell lung cancer, where it is being compared with docetaxel. It is also being evaluated in 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 death ligand 1, a protein that tumors use to suppress immune responses. By binding PD-L1, the agent is designed to interfere with that immune evasion pathway. PD-L1 positivity is used as a biomarker to select patients for the non-small cell lung cancer study of PF-08046054.
PF-08046054 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The compound is also referred to as PF-08046054/SGN-PDL1V, reflecting its development history. Pfizer is running the clinical program, including the Phase 3 non-small cell lung cancer study and the Phase 1 solid tumor study.
PF-08046054 is in Phase 3 development for previously treated PD-L1 positive non-small cell lung cancer, with a Phase 1 study also ongoing in advanced solid tumors. It is investigational and has not been approved by the FDA. The Phase 3 trial is currently recruiting participants and is comparing PF-08046054 with docetaxel.
PF-08046054 is being evaluated in two registered studies. NCT07144280 is a Phase 3 trial comparing PF-08046054 with docetaxel in adults with previously treated PD-L1 positive non-small cell lung cancer, enrolling about 680 participants across many countries. NCT05208762 is a Phase 1 study of PF-08046054 in advanced solid tumors, including non-small cell lung cancer, head and neck cancer, esophageal cancer, triple negative breast cancer, gastric cancer, endometrial cancer, pancreatic adenocarcinoma, and hepatocellular carcinoma.