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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.

Disitamab vedotin (PF-08046051)

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Disitamab vedotin (PF-08046051)

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Overview + Rationale

  • Disitamab vedotin (DV) is an investigational antibody-drug conjugate that contains 3 components: a recombinant, humanized, high affinity IgG1 monoclonal antibody directed to human epidermal growth factor receptor (HER2), a microtubule-disrupting agent MMAE (monomethyl auristatin E), and a protease-cleavable mc-vc (maleimidocaproyl-valine-citrulline) linker that covalently attaches MMAE to the antibody, which enables preferential release of MMAE within target cells
  • DV binds to a distinct epitope on subdomain IV of the HER2 extracellular domain1,4
  • HER2 is a receptor tyrosine kinase2 that is overexpressed or amplified in multiple cancers, including breast, bladder, gastroesophageal, colorectal, ovarian, and lung3
  • DV is optimized for enhanced internalization and delivery of cytotoxic MMAE to target cells

 

Partner: RemeGen Co. Ltd.

Mechanism of Action

Stage of Development

Disitimab vedotin is being investigated in the tumor types shown below. Safety and efficacy for the uses listed below have not been established.

Small icon representing GU Cancer

Urothelial Cancer with HER2 Expression

Phase 2 Monotherapy and Combination

Phase 3 Combination
small icon representing Other/Multiple Cancer Types

Advanced or Metastatic Solid Tumors with HER2 Expression (previously treated)

Phase 2 Monotherapy*
small icon representing breast cancer

HER2+ Breast Cancer with HER2 Expression

Phase 1 Monotherapy and Combination

Phase 1b/2 Monotherapy
small icon representing GI Cancer

GI Cancers with HER2 Expression

Phase 1b/2 Monotherapy and Combination
This information is current as of August 5th 2025.

*Closed to enrollment

REFERENCES:  1. Yao X. Cancer Res Treat. 2015: 123-33; 2. Li H. Cancer Biol Ther. 2016: 346-54; 3. Jiang J. Eur J Pharm Sci. 2016: 274-86; 4. Li L. Eur Rev Med Pharmacol Sci. 2020: 12929-37; 5. Klussman K. SITC 2020: Poster 618; 6. Cao AT. AACR 2017: Abstract 5588; 7. NCT04879329. https://clinicaltrials.gov/ct2/show/NCT04879329  8. NCT05911295. https://clinicaltrials.gov/ct2/show/NCT05911295  9. NCT06003231. https://clinicaltrials.gov/ct2/show/NCT06003231. 10. NCT06966453 https://clinicaltrials.gov/study/NCT06966453 Accessed July 15, 2025; 11. NCT06157892. https://clinicaltrials.gov/study/NCT06157892, Accessed July 7, 2025