The following is a summary of “Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up,” published in the July 2023 issue of Oncology by Powles, et al.
Updated results from the phase III JAVELIN Bladder 100 trial confirm the significant efficacy of avelumab first-line (1L) maintenance therapy plus best supportive care (BSC) in patients with advanced urothelial carcinoma (aUC). The trial showed prolonged overall survival (OS) and progression-free survival (PFS) compared to BSC alone in patients who were progression-free after 1L platinum-containing chemotherapy. For a study, researchers sought to present updated data with a follow-up period of at least 2 years, including OS (primary endpoint), PFS, safety, and additional analyses.
A total of 700 patients were randomly assigned in a 1:1 ratio to receive either avelumab plus BSC (n = 350) or BSC alone (n = 350). The median follow-up was 38.0 months and 39.6 months in the two groups, respectively, with 67 patients (19.5%) receiving avelumab treatment for at least 2 years. The results showed that OS remained significantly longer in the avelumab plus BSC group compared to the BSC alone group (hazard ratio, 0.76 [95% CI, 0.63 to 0.91]; 2-sided P = .0036). Investigator-assessed PFS analyses also favored avelumab treatment. The longer-term safety profile was consistent with previous analyses, and no new safety concerns emerged with extended treatment duration.
In conclusion, the updated data with more than 2 years of follow-up reaffirmed the clinically significant efficacy benefits of avelumab 1L maintenance plus BSC compared to BSC alone in patients with aUC. The findings supported using avelumab as a standard of care in the 1L maintenance setting for aUC. An interactive visualization tool was available for more detailed visualization of the reported data.