FDA greenlights maintenance avelumab for advanced bladder cancer

  • US Food and Drug Administration
  • 30 Jun 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has approved avelumab maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy.
  • The recommended avelumab dose is 800 mg administered as an intravenous infusion over the course of 60 minutes every 2 weeks.

Why this matters

  • The FDA had granted accelerated approval to avelumab based on promising response in preliminary data.

Key highlights

  • Randomized, multicenter, open-label JAVELIN Bladder 100 trial
  • 700 patients with unresectable, locally advanced or metastatic urothelial carcinoma that had not progressed with first-line platinum-containing chemotherapy were randomly assigned to receive best supportive care with or without avelumab.
  • The median OS significantly improved with avelumab in:
    • Overall population: 21.4 vs 14.3 months.
      • HR: 0.69 (P=.001).
    • Patients with programmed death-ligand 1 (PD-L1)-positive tumors.
      • HR: 0.56 (P<.001>
  • In an exploratory analysis, no OS benefit was observed in patients with PD-L1-negative tumors
    • HR: 0.85 (95% CI, 0.62-1.18).
  • The most common adverse reactions (>20%) were fatigue, musculoskeletal pain, urinary tract infection, and rash.
  • 28% of patients reported serious adverse events, and 1 patient died from sepsis.

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