Petros Grivas, MD, PhD Seattle Cancer Care Alliance discusses FDA Approves Avelumab (BAVENCIO) as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma
The approval is focused on the findings of the JAVELIN Bladder 100 Phase III trial, which showed a substantial 7.1-month increase in median overall survival ( OS) relative to BSC alone with BAVENCIO as first-line maintenance plus best supportive treatment (BSC): 21.4 months (95 % CI: 18.9 to 26.1) vs. 14.3 months (95 % CI: 12.9 to 17.9).1 This statistically significant improvement in BSC alone
Based on high initial response rates, platinum-based chemotherapy is currently the first-line standard of treatment for qualifying advanced disease patients. However, most patients will finally undergo disease progression within nine months of initiation of treatment,3,4 and only 5% will survive more than five years for patients with metastatic disease at diagnosis.
BAVENCIO is given as first-line maintenance therapy before disease progression or inappropriate toxicity in patients who do not advance with platinum-containing chemotherapy.
Under the Accelerated Approval Program, the FDA previously approved BAVENCIO in 2017 for the treatment of patients with locally advanced or metastatic UC who have disease progression during or after platinum-containing chemotherapy or who have disease progression within 12 months of platinum-containing neoadjuvant or adjuvant chemotherapy treatment based on tumor response rate and durati-containing chemotherapy The continued approval was based on the clinical benefit verification demonstrated in JAVELIN Bladder 100. The accelerated approval has now been converted by the FDA to complete approval.