A European Medicines Agency (EMA) committee has adopted a positive opinion on Bavencio (avelumab), recommending its approval as a first-line maintenance treatment for adults with locally advanced or metastatic bladder cancer (urothelial carcinoma) who have not progressed after platinum-based chemotherapy.
The opinion, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), will now be reviewed by the European Commission.
A decision on Bavencio’s approval is expected early next year.
“With this positive opinion, we have come a big step closer to being able to offer a new option that may shift the treatment paradigm for patients in Europe,” Danny Bar-Zohar, MD, global head of development for the biopharma business of Merck KGaA, said in a press release. Merck (known as EMD Serono in North America) is jointly developing Bavencio with Pfizer.
Bavencio is an immune checkpoint inhibitor, a type of medication that allows the immune system to more effectively attack cancer cells. Specifically, it is a monoclonal antibody that blocks PD-L1, a protein that tumor cells use to limit anti-cancer immune activity.
In July 2020, Bavencio was approved in the U.S. as a first-line maintenance treatment for the same indication, urothelial carcinoma — the most common type of bladder cancer. Regulatory applications have also been submitted in Japan and other countries.
The U.S. approval and CHMP opinion were based on data from the JAVELIN Bladder 100 Phase 3 trial (NCT02603432). The trial, conducted across 197 sites in 29 countries, enrolled 700 people with locally advanced or metastatic urothelial carcinoma who did not experience disease progression after first-line chemotherapy.
The participants were randomly assigned to receive Bavencio, administered via intravenous (into-the-bloodstream) infusions every two weeks, in addition to best supportive care, or best supportive care alone.
Results from the trial were recently published in The New England Journal of Medicine, in the study, “Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.”
The data demonstrated that the trial met its primary goal of overall survival. Patients receiving Bavencio lived significantly longer (a median of 21.4 months) than those on best supportive care only (14.3 months), which translated into a 31% reduction in the risk of death.
Those survival benefits were particularly more evident in the subset of participants who had PD-L1-positive tumors, in whom Bavencio reduced the risk of death by 44%.
Progression-free survival, called PFS — the time a patient remains alive without signs of tumor progression — also was significantly longer with Bavencio, both in the overall population (3.7 months vs. 2 months) and in the subset with PD-L1-positive tumors (5.7 months vs. 2.1 months).
“Patients with advanced urothelial carcinoma who had disease that had not progressed with first-line platinum-based chemotherapy had significantly longer overall survival with maintenance avelumab therapy than with best supportive care alone; this finding applied to both the overall population and the PD-L1–positive population,” the researchers concluded.
Notably, the difference in survival was significant even though participants in the control group were more frequently given subsequent treatments, including other immunotherapies, as part of receiving best supportive care.
This finding, “highlights the benefit of starting avelumab immediately after first-line chemotherapy instead of waiting for disease progression,” the researchers wrote.
The trial did not identify any new safety concerns associated with the treatment. The overall incidence of any adverse events was higher in the Bavencio group (98% vs. 77.7%), as was the incidence of serious adverse events (47.4% vs. 25.2%). Some of the most common adverse events associated with Bavencio included fatigue, itch, urinary tract infection, and joint pain.
Two on-study deaths were attributed to Bavencio treatment: one due to sepsis that developed after a urinary tract infection after 11 infusions, and one due to a stroke that occurred 100 days after a single Bavencio infusion.
“Bavencio is the only immunotherapy treatment to demonstrate in the first-line setting the ability to help patients with locally advanced or metastatic urothelial carcinoma live longer,” Bar-Zohar said.
“Patients living with locally advanced or metastatic urothelial carcinoma in Europe are in urgent need of more treatment options that have the potential to extend their lives,” added Chris Boshoff, MD, PhD, chief development officer, oncology, Pfizer Global Product Development.
“The overall survival results from JAVELIN Bladder 100 show the potential benefits of a first-line maintenance approach with Bavencio as a significant advancement for patients with locally advanced or metastatic urothelial carcinoma,” Boshoff said.
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