Enfortumab vedotin is a Monoclonal Antibody Conjugated owned by Astellas Pharma, and is involved in 18 clinical trials, of which 5 were completed, 11 are ongoing, and 2 are planned.

Enfortumab vedotin is an antibody drug conjugate (ADC) containing a fully human monoclonal antibody (AGS-22). It targets the cell adhesion molecule nectin-4 and conjugated, via enzyme-cleavable linker, to the cytotoxic agent monomethyl auristatin E (MMAE). The monoclonal antibody moiety of AGS-22 selectively binds to nectin-4. After internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells.

The revenue for Enfortumab vedotin is expected to reach a total of $42.4bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Enfortumab vedotin NPV Report.

Enfortumab vedotin was originated by Agensys and Seagen and is currently owned by Astellas Pharma. Seagen is the other company associated in development or marketing of Enfortumab vedotin.

Enfortumab vedotin Overview

Enfortumab vedotin (Padcev) acts an anti-neoplastic agent. It is formulated as powder for solution for intravenous route of administration. Padcev is indicated for the treatment of  adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting and also indicated in patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Padcev is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor.

Enfortumab vedotin (AGS-22, AGS-22CE, AGS-22ME, AGS-22M6E) is under development for the treatment of solid tumors including metastatic castration-resistant prostate cancer, advanced or metastatic urothelial carcinoma (mUC), urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC), bladder carcinoma, ureter cancer, urethral cancer, non-muscle invasive bladder cancer, gastric cancer, head and neck cancer, non-squamous non-small cell lung cancer, squamous non-small cell lung cancer, triple negative breast cancer, gastroesophageal junction (GEJ) cancer, esophageal cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, bladder cancer, renal pelvis, HR positive human epidermal growth factor receptor 2 negative breast cancer, ureter, ER positive human epidermal growth factor receptor 2 negative breast cancer, urethra cancer. The therapeutic candidate is administered as an intravenous and intravesical infusion. It is an antibody-drug conjugate (ADC) that acts by targeting nectin-4.

Seagen Overview

Seagen, formerly Seattle Genetics, is a biotechnology company that discovers, develops, and markets monoclonal antibody-based therapies for the treatment of cancer. It markets antibody-drug conjugates (ADCs), including Adcetris (brentuximab vedotin), for the treatment of Hodgkin’s lymphoma, T-cell lymphomas and CD30-expressing lymphomas; Padcevtm (enfortumab vedotin-ejfv) for metastatic urothelial cancers; Tukysa (tucatinib) for the treatment of metastatic HER2-positive breast cancers, and Tivdak (tisotumab vedotin-tftv) for the treatment of certain metastatic cervical cancers. The company’s pipeline consists of novel therapies for addressing the unmet medical needs of blood-related cancers and solid tumors. Seagen products and pipeline are based on ADC technology, which targets monoclonal antibodies and delivers agents for killing cancer cells. The company sells its products through specialty distributors. Seagen is headquartered in Bothell, Washington, the US.

The company reported revenues of (US Dollars) US$1,574.4 million for the fiscal year ended December 2021 (FY2021), a decrease of 27.6% over FY2020. The operating loss of the company was US$682.1 million in FY2021, compared to an operating profit of US$596.9 million in FY2020. The net loss of the company was US$674.5 million in FY2021, compared to a net profit of US$613.7 million in FY2020. The company reported revenues of US$510.3 million for the third quarter ended September 2022, an increase of 2.6% over the previous quarter.

Quick View – Enfortumab vedotin

Report Segments
  • Innovator (NME)
Drug Name
  • Enfortumab vedotin
Administration Pathway
  • Intravenous
  • Intravesical
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.