If you or a loved one has lung cancer, you may be interested in learning more about medicines used to treat it. One option is an immunotherapy medicine called Imfinzi (durvalumab). Immunotherapy medicines work by helping your immune system find and attack cancer cells.
The FDA approved Imfinzi in 2017. It is approved to treat non-small-cell lung cancer (NSCLC) in certain people. NSCLC is the most common type of lung cancer.
Imfinzi is also FDA-approved to treat other types of cancer, including a less common type of lung cancer called small-cell lung cancer (SCLC) that has spread. It is also approved to treat cancer of the bile ducts and gallbladder (biliary tract cancer) that has spread. And Imfinzi is approved to treat liver cancer that cannot be removed by surgery as well as a certain type of endometrial cancer that has spread or come back.
Imfinzi may also be used for other conditions as determined by your health care provider. This article focuses on Imfinzi for NSCLC. Below are common questions and answers about using Imfinzi for NSCLC.
What Types of Non-Small-Cell Lung Cancer Does Imfinzi Treat?
Imfinzi is FDA-approved to treat the following types of non-small-cell lung cancer (NSCLC) in adults.
Early NSCLC. Imfinzi may be used to treat early-stage NSCLC that can be removed by surgery (resectable) and does not have certain gene changes (mutations). For this use, Imfinzi is typically given before surgery to help shrink your tumor and is continued after surgery to help prevent it from coming back.
Stage III NSCLC. Imfinzi may be used to treat NSCLC that has spread within the chest (stage III) and cannot be removed by surgery (unresectable). For this use, Imfinzi is typically given to people whose cancer has been stable after they received both chemotherapy and radiation treatment.
Stage IV NSCLC. Imfinzi may be used to treat NSCLC that has spread to other areas of your body (metastatic), also known as stage IV cancer, and does not have certain gene mutations. For this use, Imfinzi is usually given along with other medicines.
You may have tests and scans to check the type and stage of your cancer. Your health care team can use these results to help find out if Imfinzi is right for you.
How Does Imfinzi Work for Non-Small-Cell Lung Cancer?
Imfinzi is a type of immunotherapy known as a checkpoint inhibitor. It helps your immune system fight cancer by blocking a checkpoint protein called PD-L1. Normally, checkpoint proteins on cells let your immune system know which cells to ignore and which cells to attack. Some types of cancer cells make large amounts of PD-L1 to try to hide from your immune cells (T cells), preventing them from attacking the cancer.
When Imfinzi blocks PD-L1, it stops this "hiding" process, which allows your T cells to find and attack the cancer cells. This boosts your body's natural immune response to cancer. By blocking PD-L1, Imfinzi can increase T cell activity, help shrink tumors, and slow down cancer growth. This may help some people live longer without their cancer getting worse.
How Is Imfinzi Given?
Imfinzi is given by a health care professional in a hospital or clinic. It is given as an infusion into a vein (intravenously). It usually takes about an hour to receive your dose of Imfinzi.
Imfinzi is given once every two, three, or four weeks. The dosage depends on your body weight and the type of cancer being treated. Your health care team can give you details about your treatment schedule.
How Long Will I Need to Use Imfinzi for Non-Small-Cell Lung Cancer?
The length of Imfinzi treatment depends on several things, such as the stage of your cancer and how the medicine affects you.
For treatment of early NSCLC that can be removed by surgery, you will likely receive Imfinzi plus chemotherapy every three weeks for up to four cycles before you have surgery. After surgery, Imfinzi is usually given once every four weeks for up to 12 cycles.
For treatment of stage III NSCLC that cannot be removed by surgery, you will likely receive Imfinzi for up to 12 months, as long as the medicine is still effective and safe for you.
For treatment of stage IV NSCLC, you may continue taking Imfinzi for as long as the medicine is still effective and safe for you.
For any stage of NSCLC, you may have to stop Imfinzi treatment earlier than planned if your cancer gets worse or you have certain side effects that make it unsafe to continue. If you have side effects, your health care provider may give your dose more slowly than usual, meaning the infusion will take longer than an hour. Or they may pause your treatment until the side effects ease or go away. In some cases, if side effects are severe or cannot be managed, they may stop your Imfinzi treatment completely.
How Was Imfinzi Studied for Non-Small-Cell Lung Cancer?
Three clinical studies were done to test how well Imfinzi works for treating non-small-cell lung cancer (NSCLC). Imfinzi’s safety was also studied by collecting information about side effects during these studies. Below are descriptions of how Imfinzi was studied for different stages of NSCLC.
Early NSCLC
The AEGEAN study tested Imfinzi in adults who had early-stage NSCLC that could be removed by surgery (resectable). To see how well Imfinzi worked, the study compared Imfinzi to a placebo (a treatment that contains no medicine). All of the people who took part in this study were newly diagnosed with NSCLC that was in early stages (stage IIa to IIIb) and were planning to have surgery to remove their tumors. Everyone also had to meet other requirements, such as having tests to confirm whether their cancer had large amounts of the PD-L1 protein. Their cancer could not have certain gene mutations.
In this study, 54% of people were White, 41% were Asian, 1% were Black, 3% were of other races, and 17% Hispanic or Latino.
Before having surgery, everyone in the study received four rounds of chemotherapy along with either Imfinzi or a placebo. After surgery, everyone was given either Imfinzi or a placebo once every four weeks for up to 12 doses. No one in the study knew if the treatment they were being given was Imfinzi or a placebo.
The AEGEAN study looked at two main outcomes (primary endpoints) to measure how well Imfinzi worked. One was to see how long people lived before their cancer got worse or came back, known as event-free survival. The other was to see how many people had a complete response after treatment, which means their test results showed no signs of cancer.
Advanced NSCLC
The PACIFIC study tested Imfinzi in adults whose NSCLC had spread within the chest (stage III, or locally advanced) and could not be removed by surgery (unresectable). Everyone in this study recently received both chemotherapy and radiation treatment and their cancer was considered stable (not getting worse). People in this study received either Imfinzi or a placebo once every two weeks for up to 12 months. During the study, no one knew which treatment they were getting.
In the PACIFIC study, 69% of people were White and 27% were Asian.
Another study, called POSEIDON, tested Imfinzi in adults whose NSCLC had spread from the lungs to other areas of the body (stage IV, or metastatic). Everyone in this study had to meet certain requirements. For example, their cancer could not have certain gene mutations. People in this study were randomly put into one of three groups and were told which of the following medicines they were getting.
- Group 1 received a medicine called tremelimumab (Imjudo), then Imfinzi plus chemotherapy.
- Group 2 received Imfinzi plus chemotherapy.
- Group 3 received chemotherapy alone.
In the POSEIDON study, 61% of people were White and 29% were Asian.
Both the PACIFIC and POSEIDON studies looked at two main outcomes (primary endpoints) to measure Imfinzi’s effectiveness. These included how long people lived before their cancer got worse, known as progression-free survival, and how long people survived overall.
What Are the Main Benefits of Imfinzi Based on Studies? (Primary Outcomes)
Across all three clinical studies, the results showed that Imfinzi was an effective treatment for non-small-cell lung cancer (NSCLC). On average, people who received Imfinzi lived longer without their cancer getting worse than people who received a placebo or chemotherapy alone.
Some of the main findings of Imfinzi’s studies are described below. Keep in mind that your results may vary from what was seen in studies.
Early NSCLC
Imfinzi for early-stage NSCLC that can be removed by surgery (AEGEAN Study). Overall, people who were treated with Imfinzi/chemotherapy before surgery and Imfinzi after surgery lived for a longer time before their cancer came back or got worse, compared to those who received chemotherapy before surgery and a placebo after surgery. A complete response was seen in 17.2% of the Imfinzi group, which means their test results showed no signs of cancer. In comparison, 4.3% of people who received chemotherapy/placebo had a complete response.
Advanced NSCLC
Imfinzi for stage III NSCLC that cannot be removed by surgery (PACIFIC study). On average, people who were treated with Imfinzi lived 16.8 months before their cancer got worse. In comparison, people who received a placebo lived 5.6 months before their cancer progressed. Nearly four years after this study began, 62% of the people from the Imfinzi group were still alive, while 51% of those in the placebo group were still alive.
Imfinzi for stage IV NSCLC (POSEIDON study). On average, people who were treated with Imjudo then Imfinzi plus chemotherapy lived 6.2 months before their cancer got worse, and they survived 14 months overall. In comparison, people who received chemotherapy alone lived 4.8 months before their cancer progressed, and they survived 11.7 months overall.
What Can I Do to Prevent or Manage Side Effects of Imfinzi?
Immunotherapy medicines like Imfinzi can help your immune system find and attack cancer cells. But they can also cause your immune system to attack healthy parts of your body. This can lead to inflammation in different organs and tissues, which can become severe or even life-threatening in some cases. These reactions can happen at any time during treatment with Imfinzi or even after you stop it.
While these side effects can be serious, early detection and management can help prevent them from getting worse. Keep track of any new or worsening symptoms. If something feels off, do not wait – contact your health care provider right away. While not a complete list, here are some areas of the body that may become inflamed and the symptoms to watch for.
Lungs. If you get a lasting cough, shortness of breath, or chest pain that is worse than usual, these could be signs of lung inflammation.
Digestive tract. Diarrhea, black or bloody stools, and stomach pain could mean your intestines are inflamed.
Liver. Symptoms like yellowing skin or eyes, severe nausea, or pain in your upper right belly area may be symptoms of liver inflammation.
Hormone glands. Hormone changes may cause headaches, unusual tiredness, or changes in weight or mood.
Kidneys. Decreased urine, blood in your urine, or swelling in your ankles could signal kidney problems.
Skin. Watch for rashes, itching, blistering, or peeling skin.
Pancreas. Severe stomach pain, vomiting, or dark urine may be signs of pancreas inflammation.
Your health care provider will also monitor you closely during treatment. Make sure to keep all appointments and get any recommended tests to catch side effects early. If side effects from Imfinzi become severe, your treatment may be paused or stopped altogether.
Is There Any Cost Assistance Available?
A cost assistance program is available from the maker of Imfinzi, AstraZeneca. If you qualify, this program may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured.
Visit this website for more information about Imfinzi costs and copay savings. You can also call the drugmaker at 844-275-2360 to connect with a representative for financial support information and other resources.
