An updated analysis of the phase III JAVELIN Bladder 100 trial continued to show benefits in overall survival and progression-free survival with avelumab maintenance plus best supportive care vs best supportive care alone in patients with advanced urothelial carcinoma who were progression-free after first-line platinum-containing chemotherapy. The updated findings were reported in the Journal of Clinical Oncology by Powles et al.
Study Details
The primary analysis of the trial supported the June 2020 approval of avelumab in this setting on the basis of benefit in overall survival (primary endpoint) and progression-free survival.
In the international open-label trial, 700 patients were randomly assigned to receive maintenance avelumab plus best supportive care (n = 350) or best supportive care alone (n = 350). The updated analysis included data from ≥ 2 years of follow-up in all patients.
Key Findings
At data cutoff (in June 2021), median follow-up was 38.0 months in the avelumab group vs 39.6 months in the control group. A total of 67 patients (19.5%) in the avelumab group had received at least 2 years of avelumab therapy.
Median overall survival was 23.8 months (95% confidence interval [CI] =19.9–28.8 months) in the avelumab group vs 15.0 months (95% CI = 13.5–18.2 months) in the control group (hazard ratio [HR] = 0.76, 95% CI = 0.63–0.91, P = .0036). Rates at 2 years were 49.8% (95% CI = 44.3%–55.0%) vs 38.4% (95% CI = 33.2%–43.7%).
Median progression-free survival was 5.5 months (95% CI = 4.2–7.2 months) in the avelumab group vs 2.1 months (95% CI = 1.9–3.0 months) in the control group (HR = 0.54, 95% CI = 0.46–0.64, P < .0001). Rates at 2 years were 23.4% (95% CI = 18.9%-28.3%) vs 7.1% (95% CI = 4.5%–10.4%).
Subsequent anticancer drug therapy was received by 52.9% of the avelumab group vs 72.0% of the control group, including PD-1/PD-L1 inhibitors in 11.4% vs 53.1%, respectively. No new safety signals were identified with longer follow-up.
The investigators stated: “In conclusion, longer-term follow-up continues to show clinically meaningful efficacy benefits with avelumab [first-line] maintenance plus [best supportive care] versus [best supportive care] alone in patients with [advanced urothelial carcinoma]. An interactive visualization of data reported in this article is available [Clinical Trials Dashboard: JAVELIN Bladder 100 trial: Results after ≥ 2 years of follow-up, 2023. https://clinical-trials.dimensions.ai/javelin/].”
Thomas Powles, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, St Bartholomew’s Hospital, London, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Pfizer and the health-care business of Merck KGaA. For full disclosures of the study authors, visit ascopubs.org.
