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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

PDL1V | PD-L1-directed Antibody Drug Conjugate

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PDL1V | PD-L1-directed Antibody Drug Conjugate

PF-08046054 is an investigational compound. Its safety and efficacy have not been established

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Overview + Rationale

  • PDL1V (PF-08046054) is a PD-L1-directed vedotin antibody-drug conjugate (ADC) that consists of a microtubule-disrupting agent (monomethyl auristatin E [MMAE]) connected to an anti-PD-L1 antibody by a protease-cleavable mc-vc linker.1
  • PD-L1 functions as an immune checkpoint protein across many solid tumor types.
  • PD-L1 expression on cancer cells facilitates tumor growth and immune evasion by suppressing T cells in the tumor microenvironment.1
  • PD-L1 expression is elevated in multiple solid tumors, including head and neck squamous cell carcinoma, non-small-cell lung cancer, melanoma, triple-negative breast cancer, urothelial cancer, cervical cancer, gastric cancer, ovarian cancer, and esophageal cancer2-17
  • The elevated expression of PD-L1 in solid tumors relative to normal tissue makes it an ideal molecular target for ADCs2
  • The primary MOA of PDL1V is induction of tumor cell death through direct cytotoxicity via MMAE delivery to PD-L1 expressing cancer cells, bystander effect, and immunogenic cell death (ICD).1
  • The PDL1V antibody has been designed to enable targeting of PD-L1 with an ADC through engineering for potential of increased internalization and payload delivery2
  • While PDL1V targets PD-L1, pharmacokinetic data suggests traditional checkpoint inhibition through blockade of PD-(L)1 interactions is unlikely2

Mechanism of Action

Stage of Development

Other

Advanced Solid Tumors

Phase 1 Monotherapy and Combination
Other

Thoracic Cancer & Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 1 Monotherapy and Combination

Phase 3 Monotherapy
This information is current as of November 10th 2025.

REFERENCES: 1. National Institute of Health.  NCI Drug Dictionary.  https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-l1-antibody-drug-conjugate-sgn-pdl1v/  Accessed 10/13/25  2. Kwan B, et al. Journal for ImmunoTherapy of Cancer. 2021;9; 3. Chen DS. Immunology. 2013: 1-10; 3. Pardoll DM. Nat Rev Cancer. 2012: 252-64; 4. O'Malley D. Mod Pathol. 2019: 929-42; 5. Cha JH. Mol Cell. 2019: 359-70; 6. Balar A. Lancet Oncol. 2017: 1483-92; 7. Burtness B. Lancet. 2019: 1915-28; 8. Chung HC. J Clin Oncol. 2019: 1470-8; 9. Fuchs CS. JAMA Oncol. 2018: e180013; 10. Herbst R. Lancet. 2016: 1540-50; 11. Mok T. Lancet. 2019: 1819-30; 12. Reck M. N Engl J Med. 2016: 1823-33; 13. Robert C. N Engl J Med. 2015: 320-30; 14. Schmid P. N Engl J Med. 2020: 810-21; 15. Shah M. JAMA Oncol. 2019: 546-50; 16. Shitara K. Lancet. 2018: 123-33; 17. Varga A. Gyn Oncol. 2019: 243-50; 19. 18.  NCT05208762. https://clinicaltrials.gov/study/NCT05208762 19. NCT07144280. https://clinicaltrials.gov/study/NCT07144280  Accessed October 13, 2025.