Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 25 |
| INN | Enfortumab vedotin |
| Status | Approved |
| Drug code(s) | ASG-22ME, ASG-22CE, AGS-22M6E |
| Brand name | Padcev |
| mAb sequence source | mAb human |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine-Citrulline, mc-val-cit PABC, Cleavable linker |
| Ave. DAR | 4 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | Nectin-4 |
| Indications of clinical studies | Metastatic Urothelial Cancer and Other Malignant Solid Tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, Canada |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2011 |
| Start of Phase 2 | January 15, 2017 |
| Start of Phase 3 | June 27, 2018 |
| Date BLA/NDA submitted to FDA | July 15, 2019 |
| Year of first approval (global) | 2019 |
| Date of first US approval | December 18, 2019 |
| INN, US product name | Enfortumab vedotin, enfortumab vedotin-ejfv |
| US or EU approved indications | US: First approval for Urothelial Cancer (PADCEV is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer 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). Supplemental approvals for Urothelial Cancer (PADCEV is indicated in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer. PADCEV is indicated as a single agent for the treatment of adult patients with locally advanced or metastatic urothelial cancer who: have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinumcontaining chemotherapy, or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy) [as of December 15, 2023 label]. EU: First approval for Urothelial Cancer (PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor). Supplemental approvals for Urothelial Cancer (PADCEV, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy. PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor) [as per EPAR - Product information last updated on January 17, 2025]. |
| Company | Agensys |
| Licensee/Partner | Astellas |
| Comments about company or candidate | Dec 2019: Accelerated approval granted by FDA. July 16, 2019: A Biologics License Application (BLA) for enfortumab vedotin has been submitted to the FDA for a potential accelerated approval as a treatment for patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. NCT03474107 Phase 3 study in Urothelial cancer started in June 2018. March 2018: The FDA awarded breakthrough designation to an antibody-drug conjugate as a second-line treatment for locally advanced or metastatic urothelial cancer. Oct. 10, 2017-- Seattle Genetics, Inc. and Astellas Pharma Inc. announced dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy. The EV-201 study will assess the antitumor activity and safety of enfortumab vedotin to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations. Listed as Phase 2 in Astellas pipeline dated Jan 2017; NCT03219333 Phase 2 study recruiting as of July 20 2017. NCT02091999 Phase 1 recruiting as of Jan 2017. Listed as Phase 1 in pipeline dated Feb 2013. AGS-22M6E and ASG-22CE are fully human monoclonal antibody conjugated to a cytotoxic agent monomethyl auristatin E (MMAE) targeting Nectin-4 (Agensys code name AGS-22). The main difference between AGS-22M6E and ASG-22CE is the change in cell line for antibody production. |
| Full address of company | 2225 Colorado Avenue Santa Monica, CA 90404 United States North America United States of America https://pitchbook.com/profiles/company/52729-30#overview |
DAR: ave 3-4; mc-val-cit PABC linker.
The enfortumab vedotin active substance (AS) consists of fully human IgG1 mAb intermediate, AGS22C3, conjugated to the drug-linker (DL) intermediate of SGD-1006 (microtubule-disrupting agentMonomethyl auristatin E (MMAE)) via thioether bonds, forming an ADC. The ADC has an average molar
drug to antibody ratio (DAR) of approximately four drug molecules per antibody, resulting in a heterogeneous mixture of active conjugated isoforms. (https://www.ema.europa.eu/en/documents/assessment-report/padcev-epar-public-assessment-report_en.pdf)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |