In the JAVELIN Bladder 100 phase III trial, avelumab first-line (1L) maintenance plus best supportive care (BSC) significantly prolonged overall survival (OS) versus BSC alone in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) without progression following platinum-based chemotherapy. Older age (≥65 years) is a known risk factor for bladder cancer with a median age at diagnosis of 73.0 years. We report exploratory analyses in subgroups based on older age (≥65 years).
Eligible patients with la/mUC without progression after 1L platinum-based chemotherapy were randomized to receive avelumab plus BSC (n = 350) or BSC alone (n = 350). This exploratory analysis included subgroups aged ≥65 years, ≥65-<75 years, ≥75 years, and the subset aged ≥80 years. OS (primary endpoint) and progression-free survival (PFS) from randomization were analyzed using the Kaplan-Meier method.
Of 700 patients, 464 (66.3%) were aged ≥65 years. Median OS with avelumab plus BSC versus BSC alone was 26.1 versus 15.5 months (hazard ratio 0.70, 95% confidence interval 0.56-0.89) in all patients aged ≥65 years and 28.7 versus 17.1, 24.0 versus 13.5, and 24.9 versus 10.0 months, respectively, in patients aged ≥65-<75, ≥75, and ≥80 years. PFS analyses favored avelumab plus BSC versus BSC alone in all subgroups. No new safety concerns were identified in patients aged ≥65 years, including those treated for ≥12 months. Quality-adjusted time without symptoms or toxicity was 4.57 months longer with avelumab plus BSC versus BSC alone (a 30.35% relative improvement). Limitations include small sample size for the ≥80-year age subgroup and the exploratory design.
These exploratory analyses support the efficacy and tolerability of avelumab 1L maintenance in patients aged ≥65 years with la/mUC that has not progressed following chemotherapy, suggesting that older age should not solely prevent a patient from receiving avelumab 1L maintenance.
ESMO open. 2025 Mar 18 [Epub ahead of print]
S Gupta, M A Climent Duran, S S Sridhar, T Powles, J Bellmunt, S H Park, H Gurney, N Tsuchiya, D P Petrylak, Y Tomita, A di Pietro, J Manitz, K Tyroller, J Hoffman, N Jacob, P Grivas
Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, USA. Electronic address: ., Instituto Valenciano de Oncología, Valencia, Spain., Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada., Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK., Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, USA., Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea., Department of Clinical Medicine, Macquarie University, Sydney, Australia., Department of Urology, Yamagata University, Faculty of Medicine, Yamagata, Japan., Yale School of Medicine, New Haven, USA., Niigata University Graduate School of Medicine, Niigata, Japan., Pfizer srl, Milan, Italy., EMD Serono Research & Development Institute, Inc., Billerica, USA, an affiliate of Merck KGaA., Merck Healthcare KGaA, Darmstadt, Germany., University of Washington, Fred Hutchinson Cancer Center, Seattle, USA.