Avelumab first-line maintenance is the recommended treatment option for patients with advanced urothelial carcinoma (UC) without progression following platinum-based chemotherapy (PBC), based on the phase III JAVELIN Bladder 100 trial. High body mass index (BMI; ≥30 kg/m2) and diabetes mellitus (DM) are risk factors for bladder cancer. We report exploratory analyses from JAVELIN Bladder 100 in patients with high BMI or documented controlled DM at the time of random assignment.
JAVELIN Bladder 100 enrolled patients with advanced UC without progression after first-line PBC, who were randomly assigned to receive avelumab plus best supportive care (BSC; n = 350) or BSC alone (n = 350). The primary endpoint was overall survival (OS) from the time of random assignment.
Overall, 122 patients (17.4%) had high BMI and 114 (16.3%) had DM. After a median follow-up of ≥38 months in both arms, hazard ratios for OS with avelumab plus BSC versus BSC alone were 0.77 [95% confidence interval (CI) 0.49-1.21] in patients with high BMI and 0.60 (95% CI, 0.37-0.95) in patients with DM. Long-term safety of avelumab maintenance in these subgroups was generally consistent with that of the overall population.
Exploratory analyses support the use of avelumab first-line maintenance in patients with advanced UC without progression following PBC, including those with high BMI or DM.
ESMO open. 2026 Jun 12 [Epub ahead of print]
J B Aragon-Ching, S Gupta, P Grivas, S H Park, D P Petrylak, S S Sridhar, H Gurney, N Jacob, K Tyroller, J Hoffman, J Bellmunt
Inova Schar Cancer Institute, Fairfax, USA. Electronic address: ., Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, USA., University of Washington, Fred Hutch Cancer Center, Seattle, USA., Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Yale School of Medicine, New Haven, USA., Princess Margaret Cancer Centre, University Health Network, Toronto, Canada., Department of Clinical Medicine, Macquarie University, Sydney, Australia., Merck Healthcare KGaA, Darmstadt, Germany., EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA., Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.