FDA approves Bavencio as first line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma

Merck and Pfizer Inc.have announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Bavencio (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

The approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival (OS) with Bavencio as first-line maintenance plus best supportive care (BSC) compared with BSC alone: 21.4 months (95% CI: 18.9 to 26.1) vs. 14.3 months (95% CI: 12.9 to 17.9). This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population (HR 0.69; 95% CI: 0.56 to 0.86; 2-sided P=0.001). OS was measured from the time of randomization, after patients were treated with four to six cycles of gemcitabine plus cisplatin or carboplatin over a period of approximately four months. The JAVELIN Bladder 100 results were presented at the ASCO 2020 Virtual Scientific Meeting.

Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of initiation of treatment,and only 5% of patients with metastatic disease at diagnosis will live longer than five years.

For patients that do not progress on platinum-containing chemotherapy, Bavencio is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.

Comment:The FDA previously approved Bavencio under the accelerated approval program in 2017 for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, based on tumor response rate and duration of response. Continued approval was contingent upon verification of clinical benefit, which was demonstrated in JAVELIN Bladder 100. The FDA has now converted the accelerated approval to full approval.