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Thomas Flaig, MD


Long-Term Safety Analyses of Maintenance Avelumab From JAVELIN Bladder 100

By: Kayci Reyer
Posted: Monday, July 10, 2023

According to post hoc safety analyses from the phase III JAVELIN Bladder 100 trial after a minimum follow-up of 2 years, presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4516), first-line avelumab, an immune checkpoint inhibitor, may be a safe option for maintenance therapy in patients with advanced urothelial carcinoma. “These results further support the use of avelumab [first-line] maintenance until [disease] progression as standard of care for [patients with advanced urothelial carcinoma] without [disease] progression after [first-line] platinum-based chemotherapy,” concluded Joaquim Bellmunt, MD, PhD, of Dana-Farber Cancer Institute, Boston, and colleagues.

The study included patients with unresectable locally advanced or metastatic urothelial cancer who had not experienced disease progression after first-line platinum-based chemotherapy. The ad hoc analyses evaluated safety outcomes among patients who received at least one dose of maintenance avelumab. Median follow-up was 38 months, median duration of treatment was 5.8 months, and median number of infusions was 11.5.

Overall, 269 patients (78.2%) experienced treatment-related adverse events, and 67 patients (19.5%) experienced treatment-related adverse events of grade 3 or higher, the most common of which were increases in lipase (3.5%) and amylase (2.3%). For 40 patients (11.6%), a treatment-related adverse event resulted in treatment discontinuation.

A total of 111 patients (32.3%) reported immune-related adverse events, which occurred at grade 3 or higher for 26 patients (7.6%) and were considered serious for 18 patients (5.2%). For 21 patients (6.1%), an immune-related adverse event resulted in treatment discontinuation. Immune-related adverse events occurred after 12 months of treatment in 27 of the 118 patients who underwent avelumab treatment for at least 1 year.

Disclosures: For full disclosures of the study authors, visit

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