AstraZeneca has secured accelerated approval in the US for its immunotherapy Imfinzi as a treatment for certain patients with advanced bladder cancer.
The marketing authorisation allows the drug’s use in patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before or after surgery.
According to AZ, metastatic bladder cancer remains an area of unmet medical need in particular; among patients treated with standard-of-care chemotherapy, the five-year survival rate is below 15 percent.
“The usual course of treatment for patients with advanced bladder cancer begins with a standard platinum-containing chemotherapy. Patients who have disease progression during or following chemotherapy are left with few other treatment options. The approval of Imfinzi to treat this population of select patients signifies hope for those who are currently suffering, or may find themselves with limited options in the future,” said Nicholas Vogelzang, clinical professor at the University of Nevada School of Medicine.
The accelerated approval of Imfinzi, a human monoclonal antibody that blocks PD-L1, is based on data from the Phase I/II Study 1108, which showed an objective response rate (ORR) of 17.0 percent in all evaluable patients, regardless of PD-L1 status, and 26.3 percent in those with PD-L1 high-expressing tumours. Also, around 14.3 percent of all evaluable patients achieved partial response and 2.7 percent achieved complete response.
Imfinzi (darvalumab) is also under investigation in the Phase III DANUBE trial as 1st- line treatment in urothelial carcinoma as monotherapy and in combination with tremelimumab, and is also being assessed in a number of others such as lung, head and neck, liver, and blood cancers.
“Imfinzi is the cornerstone of our extensive Immuno-Oncology programme, in development across many tumour types, as monotherapy and in combination,” said AZ’ chief executive Pascal Soriot. “This first approval for Imfinzi is an important milestone in our return to growth and brings us another step closer to our goal of redefining the way cancer is treated”.
However, the drug will face competition from established immuno-oncology agents such as Bristol-Myers Squibb's Opdivo (nivolumab) and Merck's Keytruda (pembrolizumab).