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 $39.5bn 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.

Astellas Pharma Overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Tokyo, Japan.

The company reported revenues of (Yen) JPY1,296,163 million for the fiscal year ended March 2022 (FY2022), an increase of 3.7% over FY2021. In FY2022, the company’s operating margin was 12.4%, compared to an operating margin of 11.7% in FY2021. In FY2022, the company recorded a net margin of 9.6%, compared to a net margin of 9.7% in FY2021. The company reported revenues of JPY380,394 million for the second quarter ended September 2022, a decrease of 0.4% 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.