Bavencio (Avelumab), a programmed cell death ligand–1 (PD L1) inhibitor, has been approved for treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
About Urothelial Cancer
Bladder cancer is the most common type of urothelial carcinoma, and up to half of all people with the advanced form of the disease are unable to receive cisplatin chemotherapy as an initial treatment and therefore have a high unmet medical need. Urothelial carcinoma also includes cancers of the urethra, ureters and renal pelvis. According to the American Cancer Society (ACS), it is estimated that more than 79,000 Americans will be diagnosed in 2017 with bladder cancer, which is the most common type of urothelial cancer.
Bavencio targets the programmed cell death-ligand PD-1/PD-L1 pathway with potential immune checkpoint inhibitory and anti-cancer activity. When Bavencio binds to PD-L1 it blocks the interaction of PD-L1 with its receptor protein 1 (PD-1). This inhibits the activation of PD-1 and restores immune function through the activation of cytotoxic T lymphocytes targeted to PD-L1-overexpressing cancer cells.
Bavencio was granted an accelerated approval by the US Food and Drug Administration (FDA) on the basis of a single clinical trial that enrolled 242 patients. All patients in the clinical trial had locally advanced or metastatic urothelial carcinoma and had experienced disease progression while receiving or after having received platinum-based chemotherapy or within 12 months of receiving a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
Patients were treated with intravenous Bavencio every 2 weeks until cancer progression or unacceptable side effects. The results of the clinical trial confirmed an overall response rate of 13.3% to 16.6% although additional follow up is required. Patients took on average 2.0 months (range, 1.3 – 11.0) to respond to treatment and the average duration of response had not been reached.
Bavencio joins three similar immunotherapies already approved for the treatment of bladder cancer, expanding patients options for treatment for the first time in many years.