Dr Gupta on Avelumab Maintenance Therapy in Advanced Urothelial Cancer With Diabetes

"The OS benefit [with avelumab plus BSC vs BSC alone] was well maintained in [patients with diabetes] compared [with those without diabetes]. This is reassuring news."

Shilpa Gupta, MD, director of Genitourinary Medical Oncology at the Taussig Cancer Institute and co-leader of the Genitourinary Oncology Program in the Department of Hematology and Medical Oncology, Cleveland Clinic; as well as a member of the Developmental Therapeutics Program at the Case Comprehensive Cancer Center, discusses findings from an analysis of long-term outcomes with frontline maintenance avelumab (Bavencio) according to diabetes mellitus status in patients with advanced urothelial carcinoma from the phase 3 JAVELIN Bladder 100 trial (NCT02603432).

The pivotal JAVELIN Bladder 100 trial previously established avelumab as the standard-of-care maintenance therapy in the frontline setting for patients with locally advanced or metastatic urothelial carcinoma who had prior exposure to and did not progress on platinum-based chemotherapy consisting of gemcitabine plus either cisplatin or carboplatin, Gupta begins. Patients were randomly assigned to receive avelumab maintenance therapy plus best supportive care (BSC) or BSC alone. The study demonstrated a significant improvement in overall survival (OS) with avelumab-containing maintenance therapy vs BSC alone. 

After more than 3 years of follow-up, the OS benefit with avelumab in this population has remained consistent, Gupta says. A subgroup analysis was conducted to evaluate outcomes in patients with and without diabetes mellitus, given the potential for increased adverse effects in this population and the possible exacerbation of diabetes-related complications by immunotherapy, she explains.

Findings confirmed that the OS benefit with avelumab maintenance therapy was maintained in patients with diabetes. Among patients with diabetes, the median OS with avelumab plus BSC (n = 55) was 20.8 months (95% CI, 18.0-32.4) vs 14.5 months (95% CI, 11.7-21.3) with BSC alone (n = 59). These respective values among patients without diabetes were 24.7 months (n = 295; 95% CI, 19.9-30.0) and 15.8 months (n = 291; 95% CI, 13.3-18.7). Additionally, no long-term safety concerns specific to patient with diabetes were observed, reinforcing the efficacy of the regimen and its tolerability across different patient subgroups, Gupta concludes.