Immunotherapy Avelumab Receives FDA Approval for Maintenance Treatment of Urinary Tract (Bladder and Ureter) Cancer

Metastatic or locally advanced urothelial (urinary tract = ureters and bladder) cancer patients who responded to first-line platinum-containing chemotherapy became eligible for treatment with the immunotherapy drug avelumab (Bavencio) on 30 June 2020 following the United States Food and Drug Administration (FDA) approval.

To evaluate whether avelumab was effective in the maintenance treatment of urothelial cancer, a clinical trial called JAVELIN Bladder 100 was conducted. This randomized, multicenter, open-label study included 700 patients with locally advanced or metastatic urothelial cancer. These patients had previously received 4 or 6 cycles of platinum-based chemotherapy, and their cancer had not progressed during this treatment.

Patients were randomized in a 1-to-1 ratio to 2 arms; the experimental arm received best supportive care plus avelumab, while the control arm received best supportive care alone. Treatment began 4-10 weeks after the last chemotherapy dose.

The main efficacy outcome measure to be assessed in the study, both in all patients and in those with PD-L1-positive tumors, was overall survival.

• For all patients, median overall survival was 21.4 months in the avelumab arm and 14.3 months in the best-supportive-care-alone arm.
• Of the patients, 51% were PD-L1-positive, and the use of immunotherapy avelumab in these patients reduced the risk of death by 44%.
• In patients with PD-L1-negative tumors, avelumab use reduced the risk of death by 15%.

In >20% of patients receiving avelumab, the most common adverse effects were fatigue, musculoskeletal pain, urinary tract infection and rash. One patient died of sepsis (a serious infection), and 28% of patients had serious adverse effects (see immunotherapy adverse effects).

The recommended avelumab dose is administered every 2 weeks as an intravenous infusion over 60 minutes, at 800 mg, until disease progression or the development of unacceptable adverse effects.

Avelumab had previously received approval for Merkel cell carcinoma in 2017, advanced urothelial carcinoma in 2017, and advanced kidney cancer in combination with axitinib in 2019, for a total of 3 FDA approvals.

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The urinary tract organs consist of the kidneys, ureters (the tubes between the kidneys and bladder), bladder (the urine storage sac) and urethra (the channel connecting the bladder to the outside of the body). Urothelial cancers involve the organs of the urinary tract "other than the kidneys".