A novel combination of cancer medications seems to significantly prolong the overall survival of patients with advanced bladder cancer when compared to the conventional chemotherapy treatments that are currently considered standard practice.
This groundbreaking research, unveiled at the European Society for Medical Oncology Congress in Madrid, reveals that a blend of enfortumab vedotin, an antibody drug, and pembrolizumab, an immunotherapy, administered via IV infusions, reduces the risk of disease progression or death by 55% in previously untreated patients with advanced bladder cancer that has spread to other parts of the body. This combination extends the median overall survival to 31.5 months, compared to the 16.1 months seen with standard chemotherapy.
This study is one of several recent initiatives aimed at enhancing the treatment of bladder cancer. Dr. Thomas Powles, a professor specializing in urology cancer at the University of London and the director of the Barts Cancer Centre in the United Kingdom, emphasized the challenges of chemotherapy, noting that while it provides initial benefits, resistance develops quickly, resulting in a median survival of just about a year for those with metastatic bladder cancer.
“This study demonstrated a significant breakthrough. In a large, randomized Phase 3 trial, we compared a new treatment – a combination of two new drugs – with the standard chemotherapy,” explained Dr. Powles. “In this randomized trial, the use of these two drugs together resulted in a remarkable 50% reduction in the risk of death from this cancer. We effectively doubled the survival rate, with patients now living twice as long and experiencing long-term durable remission.”
Bladder cancer is a global concern, ranking as the sixth most common cancer in men, and it claims the lives of approximately 200,000 individuals each year, particularly those in advanced stages where the disease has spread beyond the bladder. Typical treatments are stage-dependent and may involve surgical procedures or conventional chemotherapy drugs such as carboplatin and cisplatin.
Notably, this new research, funded by U.S. pharmaceutical companies Seagen, Inc., Astellas Pharma, and Merck & Co., comes at a time when the United States is facing a significant shortage of platinum-based chemotherapy drugs, including carboplatin and cisplatin. A novel combination
The Phase 3 trial involved 886 patients who were randomly assigned to either receive the enfortumab vedotin and pembrolizumab combination in three-week cycles via IV infusions or undergo a chemotherapy regimen consisting of gemcitabine with cisplatin or carboplatin.
The findings from this trial indicate that the new drug combination has a safety profile comparable to that of chemotherapy, with adverse reactions, such as skin rashes or hyperglycemia, occurring in 55.9% of patients using the combination, compared to 69.5% in the platinum chemotherapy group.
Dr. Powles mentioned, “We only received the data three weeks ago, so it’s developing very rapidly.” The next step for the research team is to submit their data to regulatory agencies, including the US Food and Drug Administration, and other health organizations worldwide. It’s important to note that this data has not yet undergone peer-reviewed publication in a scientific journal.