Padcev (enfortumab vedotin-ejfv)

Accordingly, gemcitabine-cisplatin with nivolumab and platinum-based chemotherapy followed by maintenance avelumab remain validated evidence-based alternatives, particularly for cisplatin-eligible patients or in regions where enfortumab vedotin plus pembrolizumab is not readily accessible...Enfortumab vedotin monotherapy retains activity post-platinum and immune checkpoint inhibition, erdafitinib provides a targeted benefit in fibroblast growth factor receptor 3-altered tumors, and trastuzumab deruxtecan has emerged as a later-line option for HER2-positive disease. In parallel, circulating tumor DNA is an emerging biomarker with potential to individualize sequencing strategies, although its clinical application remains investigational. This review synthesizes current evidence and highlights practical considerations, emphasizing the need to balance therapeutic innovation with cost effectiveness, equitable access, and global applicability, while identifying critical research priorities in the post-enfortumab vedotin plus pembrolizumab era.

P2, N=27, Recruiting, National Cancer Center, Japan

P2, N=24, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Jun 2026 --> Jun 2027

P1/2, N=230, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P3, N=608, Completed, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Completed

The current first-line systemic treatment for metastatic bladder cancer (mBC) is chemoimmunotherapy or immunotherapy with pembrolizumab plus enfortumab vedotin (EV). No significant changes in immune cell infiltrations (CD4+, CD8+, or F4/80+) between groups may explain anti-PD-1 immunotherapy resistance. Therefore, the novel TKO metastatic model represents a useful and reproducible tool for studying tumor-cell dissemination, bone/lung metastasis, and the underlying mechanisms of anti-PD-1 immunotherapy resistance.

P2, N=25, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Not yet recruiting --> Recruiting

P1/2, N=55, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting

Crucially, PET-measured target engagement predicted therapeutic outcomes more reliably than either drug dose or baseline target expression. By defining effective target engagement levels needed for optimal therapeutic outcomes, PET imaging provides a clear benchmark for dosing decisions, maximizing efficacy while potentially reducing exposure to higher, toxic doses and thereby enhancing patient safety.

This exceptional case demonstrates a prolonged dual response of urothelial and lung adenocarcinomas to enfortumab vedotin. It highlights the potential role of nectin-4-targeted therapy beyond urothelial carcinoma and supports further investigation of this agent in non-small cell lung cancer.

Recent advances in targeted therapies, including FGFR inhibitors (for example, erdafitinib) and antibody‑drug conjugates (ADCs) targeting Nectin‑4 (enfortumab vedotin) and HER2 (disitamab vedotin), have reshaped treatment paradigms. The present review synthesizes current evidence on molecularly guided therapies, contrasts resistance mechanisms between FGFR inhibitors and ADCs, and evaluates strategies to overcome therapeutic limitations. By integrating translational insights and emerging preclinical data, it was aimed to provide a roadmap for optimizing biomarker‑driven approaches, novel combinations and next‑generation agents for the treatment of UC.

P3, N=450, Recruiting, Eli Lilly and Company | Not yet recruiting --> Recruiting