News
Article
FDA Grants Priory Review for Human Monoclonal Antibody Drug to Treat Muscle-Invasive Bladder Cancer
Author(s):
Durvalumab could offer further treatment for individuals with muscle-invasive bladder cancer.
The FDA has accepted and granted priory review to a supplemental biologics license application (sBLA) for durvalumab (Imfinzi; AstraZeneca) to treat individuals with muscle-invasive bladder cancer (MIBC).1
“New options for muscle-invasive bladder cancer are vital because nearly half of patients will see their cancer return or progress despite undergoing curative-intent treatment, including removal of their bladder,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, in a news release.1
Image credit: shidlovski | stock.adobe.com
According to the American Cancer Society, bladder cancer most commonly occurs in individuals over the age of 55, with an average diagnosis age of 73 years old. The chance of men developing bladder cancer in their lifetime is higher than women, with an incidence of 1 in 28 for men compared to 1 in 89 for women. The study authors noted that about half of diagnoses are found when the cancer is restricted to the inner layer of the bladder wall, known as non-invasive or in situ cancers. Conversely, around 1 in 4 bladder cancer cases spread into deeper layers of the bladder wall but remain contained in the bladder, known as MIBC.1,2
Approximately 17,000 individuals with MIBC are treated with current standard of care therapies, which include neoadjuvant chemotherapy and radical cystectomy treatment. However, even after treatment, many individuals face high rates of disease recurrence and a poor prognosis, emphasizing the need for further treatment options.1
As a human monoclonal antibody, durvalumab binds to the PD-L1 protein and blocks the interaction of PD-L1 with PD-1 and CD80 proteins, offsetting the tumor’s immune-evading tactics and emitting the inhibition of immune responses. Durvalumab in combination with other chemotherapies has been approved to treat forms of non-small and small cell lung cancer, biliary tract cancers, and endometrial cancers. Since its first approval in 2017, more than 374,000 individuals have been treated with the drug, according to study authors.1
The sBLA was based on data from the NIAGARA phase 3 trial that assessed treatment with durvalumab plus neoadjuvant chemotherapy before radical cystectomy followed by durvalumab as adjuvant monotherapy, or neoadjuvant chemotherapy before radical cystectomy among individuals with MIBC.1
According to the news release, results from a planned interim analysis showed that perioperative durvalumab demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone (based on event-free survival [EFS] hazard ratio 0.68; 95% confidence interval 0.56-0.82; p<0.0001). However, the estimated median EFS was not achieved for individuals treated with durvalumab, compared to 46.1 months in the comparator arm. Additional results found that an estimated 67.8% of individuals treated with durvalumab were event free at 2 years, compared to 59.8% of individuals treated in the comparator arm.1
Results from the key secondary end point of overall survival (OS) demonstrated that the durvalumab perioperative regimen reduced the risk of death by 25% and an estimated 82.2% of individuals were alive after 2 years, compared to 75.2% in the comparator arm.1
The study authors noted that durvalumab was well tolerated and did not provide any new safety signals in the neoadjuvant and adjuvant setting.1
“Today’s Priority Review designation recognizes the urgent need for new options for these patients and the potential of Imfinzi to transform the standard of care as the first and only perioperative immunotherapy regimen to delay recurrence and extend survival in this setting,” said Galbraith, in a news release.1
