(UroToday.com) Joaquim Bellmunt presents the long-term safety data for the JAVELIN Bladder 100 trial, which evaluated avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC).
The JAVELIN Bladder 100 trial1 was a landmark study that demonstrated that treatment with Avelumab (AVE) maintenance therapy in the first line on top of best supportive care (BSC) significantly prolonged overall survival (OS) and progression free survival (PFS) in patients with against your filial carcinoma that had not progressed after first line chemotherapy.
Prior studies have reported on the safety profile of avelumab in this setting. the safety profile of avelumab at initial publication was consistent with prior avelumab monotherapy studies with no new safety signals and no detrimental impact on quality of life. However, in this abstract, Dr. Bellmunt reports post-hoc safety analysis after a minimum two years of follow-up.
At data cutoff (6/4/2021), median follow-up was 38 months. In 344 patients who received at least one dose of avelumab, the median treatment dose was 5.8 months and the median number of infusions was 11.5. 118 patients received at least 12 months of therapy.
Baseline characteristics of the cohort are summarized below:
In all AVE treated patients (N=344):
- Any grade TRAE occurred in 269 patients (78.2%); Grade 3+ was 67 (19.5%)
- 11.6% had a TRAE that led to discontinuation
- most patients just had a single irTRAE
Among patients treated for at least 12 months (N=118):
- Any grade TRAE occurred in 59 patients (50%); Grade 3+ was 14 (11.9%)
- 10.2% had a TRAE that led to discontinuation
- most patients just had a single irTRAE
As seen above most patients had a single irTRAE. When looking at the nature of immune related TRAEs, these are summarized below:
Presented by: Joaquim Bellmunt, MD, PhD, Medical Oncologist, Dana Farber Cancer Institute
Written by: Thenappan (Thenu) Chandrasekar, MD – Urologic Oncologist, Associate Professor of Urology, University of California, Davis, @tchandra_uromd @UCDavisUrology on Twitter during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, Fri, June 2 – Tues, June 6, 2023.
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