[CLINICAL INVESTIGATION OF ENFORTUMAB VEDOTIN FOR ADVANCED UROTHELIAL CARCINOMA AFTER CHEMOTHERAPY AND IMMUNOTHERAPY].

Authors

Taro Okazaki, Naoto Kamiya, Takahide Noro, Hayato Oda, Shuhei Kojima, Yusaku Hayashi, Takumi Nemoto, Mio Inui, Naoki Ishitsuka, Yuta Suzuki, Shota Iijima, Yuka Sugizaki, Takatoshi Somoto, Ryo Oka, Takanobu Utsumi, Takumi Endo, Hiroyoshi Suzuki

Published in

Nihon Hinyokika Gakkai zasshi. The japanese journal of urology. Volume 116. Issue 4. Pages 97-105.

Abstract

(Purpose) In Japan, enfortumab vedotin (EV) was approved for the treatment of locally advanced or metastatic urothelial carcinoma (la/mUC) following chemotherapy, including immune checkpoint inhibitors, in 2021. Subsequent results from the EV-302 trial demonstrated that EV combined with pembrolizumab significantly improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy when used as first-line treatment. These findings have led to a growing interest in EV due to its promising efficacy in advanced urothelial carcinoma (UC). Nevertheless, EV is known to cause specific adverse events (AEs), such as skin disorders, peripheral neuropathy, and interstitial pneumonia, necessitating vigilant clinical management. This study aimed to evaluate the real-world efficacy and safety of EV in patients with la/mUC previously treated with chemotherapy and immune checkpoint inhibitors at our institution. (Materials and methods) This retrospective analysis involved 18 patients with la/mUC who received EV for disease progression while on or after PD-1/PD-L1 inhibitors and prior platinum-based chemotherapy. All patients were treated at our institution between March 2022 and June 2024. The efficacy of EV was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, focusing on key outcomes, such as progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and disease control rate (DCR). Safety was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, focusing on treatment-related AEs. (Results) Median age of the 18 patients analyzed was 74.0 years (range: 65-86 years), and 13 were male. The median observation period was 10.5 months (range: 0-22 months). Lung metastases were the most frequently observed (in 10 patients), while no cases of liver metastasis were noted. In terms of response to treatment, none of the patients achieved a complete response, nine had partial responses (PR), six had stable disease (SD), and three experienced disease progression (PD). The median time to PR confirmation was 49.0 days (range: 11-120 days), and the median duration of response was 141.5 days (range: 8-463 days). The ORR was 50.0%, while the DCR reached 83.3%. Median OS was 15.3 months and median PFS was 14.0 months, indicating that EV provided substantial clinical benefits in this cohort. In terms of safety, AEs were observed in 94.4% of patients. Skin-related AEs were the most common, occurring in 17 of 18 patients. Importantly, no severe dermatologic events, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, were reported. Most skin AEs were manageable with topical treatments, such as steroids or antihistamines. However, more severe cases required systemic steroid therapy and discontinuation of EV treatment. Notably, the presence of skin rashes or taste disturbances was significantly associated with prolonged PFS, suggesting a potential link between these AEs and treatment efficacy. (Conclusion) EV demonstrated a high level of efficacy in patients with la/mUC who had previously received chemotherapy and immune checkpoint inhibitors. The ORR and DCR were favorable, and survival outcomes were encouraging. However, the high incidence of AEs-particularly skin-related AEs-emphasizes the need for careful monitoring and management to ensure safe and effective use of EV. These findings support EV as a valuable second-line or later treatment option for patients with advanced UC, highlighting both its therapeutic potential and the importance of toxicity management in clinical practice.

PMID:
42864041
Bibliographic data and abstract were imported from PubMed on 13 Oct 2026.

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