The European Commission (EC) has approved Bavencio (avelumab) as a first-line maintenance treatment for adults with advanced urothelial carcinoma, the most common form of bladder cancer, whose disease did not progress after platinum-based chemotherapy.
This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use, a branch of the European Medicines Agency. Bavencio was approved in the U.S. for the same indication in June 2020.
“Today’s announcement is the latest example of our decades-long commitment to developing new treatments for people with genitourinary cancers,” Andy Schmeltz, global president of Pfizer Oncology, said in a press release.
“This approval by the EC addresses an urgent unmet need, and we look forward to providing a new treatment option for people in Europe with locally advanced or metastatic urothelial carcinoma,” he added.
Jointly developed by Merck (known as EMD Serono in North America) and Pfizer, Bavencio is an immune checkpoint inhibitor, a form of immunotherapy that allows the immune system to more effectively attack cancer cells. It specifically blocks PD-L1, a cell surface protein often produced by cancer cells to “hide” from the immune system.
Approvals in the U.S. and European Union were supported by data from the JAVELIN Bladder 100 Phase 3 trial (NCT02603432), which showed that first-line maintenance therapy with Bavencio significantly extended survival and delayed disease progression in people with locally advanced or metastatic urothelial carcinoma.
“Avelumab is the only immunotherapy to demonstrate a significant improvement in overall survival in the first-line setting in a Phase III study in advanced or metastatic bladder cancer,” said Thomas Powles, MD, director of Barts Cancer Centre, in London, U.K. “With this approval by the European Commission, we can now offer patients a potential new first-line maintenance standard of care that may help them live longer.”
A total of 700 patients who were responding or had stable disease after first-line chemotherapy were enrolled in the trial. Participants were randomly assigned to receive best supportive care — such as antibiotics, nutritional support, hydration, and pain management — either alone or in combination with Bavencio.
Bavencio was administered every two weeks via intravenous (into-the-vein) infusions, until patients experienced disease progression or unacceptable side effects.
The trial met its primary goal of overall survival, demonstrating that Bavencio resulted in a 30% reduction in the risk of death. Patients who received this medication lived a median of 22.1 months, compared with 14.6 months for those assigned to best supportive care only.
Some secondary endpoints were also met, as Bavencio increased the proportion of patients who responded to treatment (9.7% vs. 1.4%) and extended the time patients lived without signs of disease progression from a median of 2 to 3.7 months — representing a 38% reduction in the risk of disease progression or death.
These survival benefits were even more pronounced in the subgroup of patients whose cancers were positive for the PD-L1 protein — which usually predicts better responses to Bavencio. In this group, the risk of death and the risk of disease progression or death were both 44% lower with Bavencio.
Based on these benefits, the therapy was added as a first-line maintenance regimen to the European Society for Medical Oncology clinical practice guidelines for bladder cancer.
“This approval allows us to extend the reach of Bavencio to even more patients with bladder cancer and offer the hope of extended survival,” said Rehan Verjee, president of EMD Serono. “This is a clear demonstration of our commitment to transform standards of care in cancer.”
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