Imfinzi (durvalumab) is a type of cancer treatment called an immunotherapy, developed by AstraZeneca and approved for the treatment of certain types of cancer of the bladder and urinary tract. Immunotherapy drugs use the body’s own immune system to fight cancer.

How Imfinzi works

A type of white blood cell called T-cells that play an important role in the normal function of the immune system are activated and can attack and destroy cancer cells.

However, some tumors can evade destruction by the immune system by using a strategy called the “PD-1/PD-L1 pathway.” PD-L1 is a protein frequently found on the surface of cancer cells. When it binds to its receptors (called PD-1) found on T-cells, the normal function of T-cells is altered, and they fail to kill cancer cells.

Imfinzi binds to the PD-L1 protein found on cancer cells, preventing it from binding to its receptors (PD-1) on T-cells, thereby restoring normal T-cell activity and stimulating the immune system to attack and kill cancer cells.

Because Imfinzi works by stimulating the immune system, it can also attack healthy organs and tissues in the body such as the lungs, liver, pancreas, kidneys, intestines, thyroid, and adrenal glands, causing serious side effects.

Imfinzi in clinical trials

Imfinzi received accelerated approval from the U.S. Food and Drug Administration (FDA) in May 2017 for the treatment of patients with cancer of the bladder or urinary tract that stopped responding to standard treatments, such as chemotherapy.

This approval was based on the rapid and durable responses observed with Imfinzi in a Phase 1/2 study (NCT01693562). This study is still ongoing at 79 sites around the world, but is no longer recruiting participants.

This was the first approval for Imfinzi, but the use of the drug continues to be investigated in bladder cancer and other types of cancer, alone and in combination with other drugs.

A Phase 3 trial (NCT02516241) called DANUBE is investigating Imfinzi as a first treatment for bladder cancer, both alone and in combination with another immunotherapy drug called tremelimumab. DANUBE is a global trial that started in November 2015 and is currently recruiting participants at 260 locations in various countries.

Imfinzi is also being investigated for the treatment of patients with lung cancer in several clinical trials (NCT03003962, NCT02453282, NCT02542293, NCT02352948, and NCT02125461).

Although it is not yet approved for patients with lung cancer, the FDA in July 2017 granted Imfinzi breakthrough therapy designation based on the results from a Phase 3 trial (NCT02125461) called PACIFIC. This trial is taking place in 235 centers across 26 countries, including the U.S., Canada, Europe, South America, Japan, Korea, Taiwan, South Africa, and Australia. Breakthrough therapy designation is designed to accelerate the development of new medicines which have shown encouraging results in early clinical trials for the treatment of serious conditions.


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