EMD Serono, the biopharmaceutical business of Merck KGaA, and Pfizer today announced that the US Food and Drug Administration (FDA) has expanded use of Bavencio (avelumab) to include maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
Clearance is based on results from the Phase III JAVELIN Bladder 100 study, which showed 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 vs. 14.3 months, respectively.
This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population, the firms noted.
“As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” said Petros Grivas, one of the principal investigators in the JAVELIN Bladder 100 trial.
“With median overall survival of more than 21 months measured from randomization, the longest overall survival in a Phase III trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease.”
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 just 5% of patients with metastatic disease at diagnosis will live longer than five years.
“Many patients newly diagnosed with advanced urothelial carcinoma receive benefit from initial chemotherapy, but we still need treatment options that can help patients live longer,” said Andrea Maddox-Smith, chief executive of the Bladder Cancer Advocacy Network. “We wholeheartedly support the development of new and promising treatments like Bavencio that can offer patients and their loved ones hope.”
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.