FDA Approves Bavencio as First-Line Maintenance for Locally Advanced or Metastatic Urothelial Carcinoma

On June 30, 2020, the FDA approved avelumab (Bavencio; Pfizer) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. This approval was based on results of the randomized, multicenter, open-label, phase 3 JAVELIN Bladder clinical trial. This study enrolled 700 patients with unresectable, locally advanced, or metastatic urothelial carcinoma that had not progressed with 4 to 6 cycles of first-line platinum-containing chemotherapy. Patients were randomized to avelumab given intravenously every 2 weeks plus best supportive care (BSC) or BSC alone.

The primary end points of the trial were overall survival (OS) in all patients and in patients with PD-L1–positive disease. Results showed that the addition of avelumab to BSC led to a 7.1-month improvement in OS in all patients (21.4 months vs 14.3 months; hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.56-0.86; P = .001). Among patients with PD-L1–positive tumors (51%), the HR for OS was 0.56 (95% CI, 0.40-0.79; P <.001).

“With median OS of more than 21 months measured from randomization, the longest OS in a phase 3 trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease,” said Petros Grivas, MD, PhD, Clinical Director of the Genitourinary Cancers Program at the Seattle Cancer Care Alliance, who was one of the principal investigators in the JAVELIN Bladder 100 trial.

The most common (>20%) adverse events associated with avelumab treatment were fatigue, musculoskeletal pain, urinary tract infection, and rash. In total, 28% of patients treated with avelumab experienced a serious adverse event, the most common of which included urinary tract infection (6.1%), pain (3.2%), acute kidney injury (1.7%), hematuria (1.5%), sepsis (1.2%), and infusion-related reaction (1.2%).

The recommended dose for avelumab is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks.

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