Enfortumab vedotin is under clinical development by Astellas Pharma and currently in Phase I for Peritoneal Cancer. According to GlobalData, Phase I drugs for Peritoneal Cancer have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Enfortumab vedotin’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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 squamous cell carcinoma, 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, cancer, nephrology, infectious diseases, and metabolic diseases, immunodeficiency, and transplantation. The company strives to develop new drugs to address high unmet medical needs with focus on biology and modality. Its pipeline consists of drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; 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 Chuo-Ku, Tokyo, Japan.

For a complete picture of Enfortumab vedotin’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 May 2024

Premium Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


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

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.