On June 30, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
JAVELIN Bladder 100
Efficacy of avelumab for the maintenance treatment of urothelial carcinoma was investigated in the JAVELIN Bladder 100 trial, a randomized, multicenter, open-label trial that enrolled 700 patients with unresectable, locally advanced, or metastatic urothelial carcinoma that had not progressed with four to six cycles of first-line platinum-containing chemotherapy. Patients were randomly assigned 1:1 to receive either avelumab intravenously every 2 weeks plus best supportive care or best supportive care alone. Treatment was initiated within 4 to 10 weeks after last chemotherapy dose. The main efficacy outcome measures were overall survival in all patients and in patients with PD-L1–positive tumors.
The median overall survival in all patients was 21.4 months in the avelumab arm and 14.3 months in the best supportive care alone arm (hazard ratio [HR] = 0.69, 95% confidence interval [CI] = 0.56–0.86, P = .001). Among patients with PD-L1–positive tumors (51%), the hazard ratio for overall survival was 0.56 (95% CI = 0.40–0.79, P < .001). In an exploratory analysis of patients with PD-L1–negative tumors (39%), the overall survival hazard ratio was 0.85 (95% CI = 0.62–1.18).
The most common adverse reactions reported in > 20% of patients who were treated with avelumab were fatigue, musculoskeletal pain, urinary tract infection, and rash. One patient died from sepsis, and 28% of patients had serious adverse reactions.
The recommended avelumab dose is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
The results from this study supported the conversion of accelerated approval of avelumab to a regular approval.