Dr Gupta on Avelumab Maintenance in Urothelial Carcinoma With/Without Diabetes Mellitus

“I believe the key [findings] are the overall survival [data]. In the US, [this approach] is not being used much now that we have enfortumab vedotin plus pembrolizumab as a frontline therapy, but this information is very important for places where this is no access to enfortumab vedotin and pembrolizumab.”

Shilpa Gupta, MD, the director of Genitourinary Medical Oncology at the Taussig Cancer Institute and the coleader of the Genitourinary Oncology Program in the Department of Hematology and Medical Oncology at the Cleveland Clinic, discussed the clinical implications of findings from a subgroup analysis of the phase 3 JAVELIN Bladder 100 trial (NCT02603432) and future research questions following updated data from the study.

During the 2025 Genitourinary Cancers Symposium, Gupta presented data in a poster from a subgroup analysis of JAVELIN Bladder 100, which examined frontline maintenance therapy with avelumab (Bavencio) for the treatment of patients with advanced urothelial carcinoma with or without diabetes mellitus.

Findings from the study revealed that patients with diabetes mellitus who received avelumab in combination with best supportive care (BSC; n = 55) experienced a median overall survival (OS) of 20.8 months (95% CI, 18.0-32.4) vs 14.5 months (95% CI, 11.7-21.3) with BSC alone (n = 59; HR, 0.60; 95% CI, 0.37-0.95). Similarly, patients without diabetes mellitus in the investigational (n = 295) and control (n = 291) arms achieved a median OS of 24.7 months (95% CI, 19.9-30.0) and 15.8 months (95% CI, 13.3-18.7), respectively (HR, 0.70; 95% CI, 0.64-0.96).

Gupta noted that the regimen used in JAVELIN Bladder 100 is not very common in the US following the emergence of enfortumab vedotin-efjv (Padcev) plus pembrolizumab (Keytruda). However, the data from the subgroup analysis are important to inform practice in other countries where enfortumab vedotin and pembrolizumab may not be as widely available, she added. Moreover, the further establishment of the absence of long-term safety issues with the JAVELIN Bladder 100 approach was key and will facilitate further research in the future, she concluded.