In the JAVELIN Bladder 100 randomized phase 3 trial (N = 700), avelumab first-line maintenance plus best supportive care (BSC) significantly prolonged overall survival (OS; primary endpoint) and progression-free survival (PFS) versus BSC alone in patients with advanced urothelial carcinoma (aUC) without progression after first-line platinum-based chemotherapy (PBC). Here, we report exploratory analyses of subgroups with nonvisceral metastases at the start of PBC (including bone metastases) or lymph node-only disease at randomization. The median OS with avelumab versus control in patients with nonvisceral metastases (n = 318) was 31.4 versus 17.1 mo (hazard ratio [HR], 0.60 [95% confidence interval {CI}, 0.45-0.79]), and in patients with lymph node-only disease (n = 102), it was 31.9 versus 22.7 mo (HR, 0.86 [95% CI, 0.51-1.47]). In patients with nonvisceral metastases, prolonged OS was observed with avelumab irrespective of the response to PBC or PBC regimen received. PFS analyses favored avelumab over control in all the subgroups. Incidences of avelumab-related adverse events were similar across the subgroups. Limitations include small sample sizes and the exploratory nature of analyses. Overall, exploratory analyses suggest that in first-line PBC-treated patients without progression, avelumab maintenance is effective and has a manageable toxicity profile in patients with aUC who have nonvisceral metastases or lymph node-only disease.
European urology. 2025 Jun 03 [Epub ahead of print]
Joaquim Bellmunt, Thomas Powles, Se Hoon Park, Eric Voog, Begona P Valderrama, Howard Gurney, Anders Ullén, Yohann Loriot, Srikala S Sridhar, Norihiko Tsuchiya, Cora N Sternberg, Jeanny B Aragon-Ching, Daniel P Petrylak, Miguel A Climent Duran, Karin Tyroller, Jason Hoffman, Natalia Jacob, Petros Grivas, Shilpa Gupta
Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: ., Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, St Bartholomew's Hospital, London, UK., Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Centre Jean Bernard Clinique Victor Hugo, Le Mans, France., Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain., Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, NSW, Australia., Department of Pelvic Cancer, Genitourinary Oncology Unit, Karolinska University Hospital, Solna, Sweden., Gustave Roussy, INSERMU981, Université Paris-Saclay, Villejuif, France., Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada., Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan., Englander Institute for Precision Medicine, Meyer Cancer Center, New York, NY, USA., Inova Schar Cancer Institute, Fairfax, VA, USA., Yale Cancer Center, New Haven, CT, USA., Instituto Valenciano de Oncología, Valencia, Spain., EMD Serono Research & Development Institute, Inc. (an affiliate of Merck KGaA), Billerica, MA, USA., Merck Healthcare KGaA, Darmstadt, Germany., Fred Hutchinson Cancer Center, University of Washington, Seattle, WA, USA., Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.