Imfinzi Approved For Extensive-Stage Small-Cell Lung Cancer

The United States Food and Drug Administration (US FDA) has approved the drug Imfinzi (durvalumab) for small-cell lung cancer. Imfinzi is specifically for people with small-cell lung cancer that has spread to other parts of the body. This is called extensive-stage small-cell lung cancer (ES-SCLC). Imfinzi is for people with ES-SCLC who have not tried any other treatment options. Imfinzi has also been approved to treat some types of bladder cancer and non-small cell lung cancer. Imfinzi is taken alongside two other chemotherapy drugs. The first is called etoposide. The second chemotherapy drug alongside Imfinzi can be either carboplatin or cisplatin.

In late 2019, Imfinzi was granted priority review by the FDA. This is a program designed to get potentially life-saving or life-extending drugs on the market quickly. This can help those struggling with a serious or life-threatening condition receive treatment faster.

How does Imfinzi work?

Imfinzi belongs to a class of drugs called monoclonal antibodies. These drugs are made from living cells and have very specific targets in the body. Imfinzi targets a protein called PD-L1. PD-L1 (programmed death-ligand 1) is on the surface of some cancer cells. It is used to trick the immune system into not attacking the cancer cells. This allows the cancer to hide from the immune system and grow without being detected by our natural cancer-fighting defenses. By blocking PD-L1 with Imfinzi, the body’s normal cancer-fighting abilities can be improved and may help prevent the cancer cells from growing.

Imfinzi in clinical trials

The FDA approved Imfinzi for ES-SCLC based on the results of a clinical trial. The phase III trial, called the CASPIAN trial, involved over 800 people across the world with ES-SCLC. There were different treatment groups in the study. The main groups considered were those who were given Imfinzi plus standard chemotherapy and those given chemotherapy alone.

The median overall survival (OS) was longer for those taking Imfinzi plus chemotherapy compared to those on chemotherapy alone (13 months versus 10.3 months). This meant the risk of death was lowered by 27 percent for those taking Imfinzi. There was also a higher response rate (the number of people responding to or benefiting from treatment) for those taking Imfinzi. The response rate was 68 percent for those taking Imfinzi versus 58 percent for those on standard chemotherapy alone. The rates of serious side effects were similar in both groups.

At the end of the trial, 43 people taking Imfinzi were still using the drug. In comparison, no one in the chemotherapy alone group was still using their same treatment option. These results all show that more people may respond to Imfinzi and that it may increase survival time in those with ES-SCLC.^1-3

What are the side effects of Imfinzi?

The most common side effects of Imfinzi include:

• Fatigue and weakness
• Hair loss
• Nausea

Things to know about Imfinzi

Several rare but serious side effects can occur with Imfinzi. These are mostly related to Imfinzi’s effect on the immune system, leading to inflammation. Inflammation of the liver, lungs, colon, kidneys, skin, or hormone-secreting glands (like the thyroid) can occur. Imfinzi may also increase a person’s risk of infection.

Imfinzi can cause harm to an unborn baby. If you or your partner could become pregnant, effective birth control should be used while taking the drug. Women taking Imfinzi should not breastfeed while on the drug.

Read the prescribing information to learn more about Imfinzi.