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Neuropathy, skin rash, and hyperglycemia following enfortumab vedotin treatment were associated with improved PFS in metastatic urothelial carcinoma.
Certain side effects following enfortumab vedotin associated with improved PFS in metastatic urothelial carcinoma: © magicmine - stock.adobe.com
For patients with metastatic bladder or upper tract urothelial carcinoma who were treated with Padcev (enfortumab vedotin, EV), the presence of neuropathy, skin rash or hyperglycemia was associated with improved progression-free survival (PFS), according to research published in a poster at the 2025 ASCO Genitourinary Cancers Symposium.
Hyperglycemia: high blood glucose levels, often due to diabetes or treatment side effects.
Progression-free survival (PFS): time a patient lives without disease progression.
Overall survival (OS): time from diagnosis or treatment to death from any cause.
After a median follow-up of 14 months from the start of Padcev, neuropathy was reported in 30 patients (36%), skin rash in 32 patients (39%) and hyperglycemia in six patients (7%). The median PFS was 4.5 months in patients who did not experience neuropathy, skin rash or hyperglycemia; 10.6 months in those with neuropathy; 8.6 months in those with skin rash; and 15.9 months in those with hyperglycemia.
Between 2018 and 2024, a total of 83 patients were treated with at least two doses of Padcev. Of these, 47 patients received Padcev plus Keytruda (pembrolizumab) and 36 patients received Padcev as a single agent. The median age was 69 years. Metastatic sites included lymph nodes (42 [50%]), lungs (34 [41%]), bones (29 [35%]), liver (16 [19%]) and brain (7 [8%]). Padcev was used as first-line therapy in 43 (52%) patients, as second-line therapy in 28 (34%), as third-line therapy in 10 (12%) and as fourth-line therapy in 2 (2%).
Utilizing a query of the Indiana University bladder cancer database, investigators identified patients with locally advanced and metastatic bladder and upper tract urothelial carcinoma treated with Padcev with or without pembrolizumab. Patients with variant histology were included. Toxicities were documented throughout treatment. The association of neuropathy, skin rash, and hyperglycemia with PFS was compared with that of patients without these side effects (SE) using the log-rank test.
“Neuropathy, skin rash, and hyperglycemia are common adverse events associated with Padcev, according to study authors,” first study author Dr. Tareq Salous and authors wrote in the abstract of the study.
Salous is an assistant professor of clinical medicine in the Department of Medicine, Division of Hematology/Oncology, at the Indiana University (IU) School of Medicine, IU Simon Comprehensive Cancer Center, and is an associate member of Experimental and Developmental Therapeutics, in Indianapolis.
According to the National Cancer Institute’s website, neuropathy is a nerve disorder causing pain, numbness, tingling, swelling or muscle weakness in various body parts, often starting in the hands or feet and worsening over time. It can result from cancer or cancer treatments like chemotherapy, as well as physical injury, infection, toxins or conditions such as diabetes, kidney failure or malnutrition. This is also known as peripheral neuropathy.
Furthermore, also in reference to the National Cancer Institute’s website, urothelial cancer originates in urothelial cells, which line the urethra, bladder, ureters, renal pelvis and other organs. Also known as transitional cells, these cells can change shape and stretch without breaking apart. This cancer is also referred to as transitional cell cancer.
Prior to the presentation at the meeting, on December 15, 2023, the FDA approved Padcev with Keytruda for locally advanced or metastatic urothelial cancer. The combination previously received accelerated approval for patients ineligible for cisplatin-based chemotherapy, according to the FDA’s website.
Approval was based on the EV-302/KN-A39 trial, an open-label, randomized study of 886 patients with locally advanced or metastatic urothelial cancer and no prior systemic therapy. Patients received either Padcev with Keytruda or platinum-based chemotherapy. The primary endpoints were overall survival (OS) and PFS.
Padcev with Keytruda significantly improved OS (median 31.5 versus 16.1 months) and PFS (median 12.5 versus 6.3 months) compared with platinum-based chemotherapy.
“Neuropathy, skin rash, and hyperglycemia as predictors of response to enfortumab vedotin in locally advanced and metastatic bladder and upper tract urothelial carcinoma.” By Dr. Salous T, et al. Presented at: Poster Session 771
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