Glossary
Overall survival (OS): the amount of time a patient survives after being diagnosed with or starting treatment for a disease.
Progression-free survival (PFS): the amount of time a patient lives with a disease without it worsening.
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Padcev Significantly Improves OS in Real-World Urothelial Carcinoma
Key Takeaways
- Padcev significantly improved overall survival in patients with unresectable or metastatic urothelial carcinoma, especially in the chemo/ICI/Padcev group.
- Skin-related side effects were linked to longer progression-free survival and overall survival, indicating potential benefits of dose adjustments.
Among patients in the real world with unresectable or metastatic urothelial carcinoma, Padcev significantly improved overall survival outcomes.
Patients in the real world with unresectable or metastatic urothelial carcinoma has improved OS with Padcev: © JAEMIN - stock.adobe.com.
Among patients in the real-world setting with unresectable or metastatic urothelial carcinoma, treatment with Padcev (enfortumab vedotin) in the third line significantly improved overall survival (OS) , according to data from the EV-301 trial which were presented at the 2025 ASCO Genitourinary Cancers Symposium.
“We aimed to investigate the efficacy and safety of Padcev in patients with unresectable or metastatic urothelial carcinoma in real-world practice,” investigators stated in a poster presentation during the meeting. “The retrospective design is a limitation.”
In the study, 419 patients with unresectable or metastatic urothelial carcinoma received treatment from April 2004 to April 2024. Patients who received the following treatments were stratified into three treatment groups: first-line chemotherapy and sequential chemotherapy alone (chemo-alone group), maintenance or second-line immunotherapy after first-line chemotherapy (chemo/ICI group; 217 patients) and Padcev after first-line chemotherapy and immunotherapy (chemo/ICI/Padcev group; 115 patients).
The primary end point in the trial was the comparison of first-line progression-free survival (PFS) and OS between these three treatment groups and secondary end points focused on skin-related side effects regarding efficacy and safety in the chemo/ICI/Padcev group.
Investigators noted that OS was significantly longer in the chemo/ICI/Padcev group; however, there was no significant difference in first-line PFS of first-line therapy between the three groups. The unadjusted OS from first-line therapy was 36 months in the chemo/ICI/Padcev group, 25 months in the chemo/ICI group and 16 months in the chemo-alone group. The chemo/ICI/Padcev group was significantly associated with improved OS, according to the investigators.
Patient Characteristics
The average age in the chemo-alone group was 67 years, 72 years in the chemo/ICI group and 74 years in the chemo/ICI/Padcev group and most patients were male: 73%, 78% and 72%, respectively. Ten percent of patients in the chemo/ICI/Padcev group had a ECOG performance status greater than 1; this information was not documented for the other 2 groups.
There were 39% of patients with upper tract urothelial carcinoma (UTUC) in the chemo-alone group, 61% in the chemo/ICI group and 45% in the chemo/ICI/Padcev group. Lymph node metastases were present in 70% in the chemo-alone group, 60% in the chemo/ICI group and 47% in the chemo/ICI/Padcev group and distant metastases were present in 76%, 67% and 70%, respectively. In addition, liver metastases were present in 11%, 12% and 13%, respectively.
Treatment History
In the chemo-alone group, 62% of patients received local therapy (54 underwent surgery and none received radiation). In the chemo/ICI group, 53% of patients received local therapy (94 underwent surgery and 18 received radiation). In the chemo/ICI/Padcev group, 59% of patients received local therapy (55 underwent surgery and 13 received radiation).
Seventy-six percent of patients in the chemo-alone group received a first-line carboplatin-based regimen, compared with 64% in both the chemo/ICI and chemo/ICI/Padcev groups. In the chemo/ICI and chemo/ICI/Padcev groups, 21% of patients each received Bavencio (avelumab) and there were no patients who did in the chemo-alone group.
Skin-Related Side Effects
Investigators noted that patients with skin-related side effects (69 patients) had significantly longer PFS and OS than those without (46 patients). In addition, a significant association between skin-related side effects and prolonged relapse-free survival and OS was observed.
The median PFS from Padcev treatment was 9.7 months for those with skin-related side effects and 5.9 months in those without. The median OS from Padcev treatment was 19 months versus 14 months, respectively. The number of cycles of Padcev treatment was seven for those with skin-related side effects and four for those without.
Padcev dose levels varied among patients, with the majority of patients with skin-related side effects receiving the 1.25 mg/kg dose in cycle 1. In contrast, the majority of patients without skin-related side effects received a dose of 1.25 mg/kg on cycle 10. However, overall patients without skin-related side effects received higher doses of Padcev throughout the 10 cycles of treatment whereas those with skin-related side effects had higher doses earlier on in the treatment course. Dose reductions occurred in 67% of patients with skin-related side effects and 35% in those without.
Patient Characteristics Related to Side Effects
The average age of patients with and without skin-related side effects was 74 years and most patients were male (67% with skin-related side effects versus 80% without). The body mass index for patients with skin-related side effects was 21.9 and 21.3 for those without. Those with an ECOG performance score greater than 1 was 7% in those with skin-related side effects and 65% in those without.
The percentage of those with UTUC and skin-related side effects was 49% and 39% in those without skin-related side effects. T4 TMN staging was observed in 30% versus 33%, lymph node metastases in 49% versus 50% and distant metastases in 68% versus 72%, each respectively. In addition, liver metastases were observed in 13% of patients with skin-related side effects and without and 64% versus 76% had chronic kidney disease stage 3, respectively.
Treatment History Related to Side Effects
Fifty-seven percent of patients with skin-related side effects had local therapy (32 patients had surgery and seven received radiation) and 63% of patients without skin-related side effects (23 patients had surgery and six received radiation). Those receiving carboplatin-based regimens were 68% and 59%, respectively. There were 14% of patients with skin-related side effects who received prior avelumab and 77% who received prior Keytruda (pembrolizumab). This percentage was 30% and 74%, respectively, in those without skin-related side effects.
“Although skin side effects often led to dose reductions, dose adjustment of Padcev may be the key for long-term use and optimizing outcomes,” investigators stated.
Reference
“Real-world analysis of the efficacy and safety of enfortumab vedotin in patients with locally advanced or metastatic urothelial carcinoma: A multicenter retrospective study” by Dr. Shingo Hatakeyama, et al., Journal of Clinical Oncology.
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