Imfinzi® (Durvalumab) for Mesothelioma

What Is Imfinzi (Durvalumab)?

Imfinzi® (durvalumab) is an immunotherapy drug. It belongs to a class of drugs known as checkpoint inhibitors. Checkpoint inhibitors block safeguards within the immune system. These safeguards are called immune checkpoints. When these checkpoints are blocked, immune cells (called T cells) can attack cells they might normally ignore, such as cancer cells. This allows the immune system to help fight cancer.

The U.S. Food and Drug Administration (FDA) has approved Imfinzi to treat certain cancers. The FDA approval covers:

• Adults who have stage 3 NSCLC that cannot be removed with surgery: Imfinzi may be used in patients whose cancer has not progressed after platinum-based chemotherapy given at the same time as radiation.
• Adults with extensive-stage small cell lung cancer (ES-SCLC): Imfinzi may be used in combination with the chemotherapy drugs etoposide and either carboplatin or cisplatin.

The FDA has also approved Imfinzi for several other cancers in adults. Lung cancer approvals include limited-stage small cell lung cancer, metastatic NSCLC and NSCLC that can be removed with surgery. Other approvals cover biliary tract cancer and liver cancer that cannot be removed with surgery. Imfinzi is also approved for mismatch repair-deficient endometrial cancer and two types of bladder cancer: muscle-invasive and high-risk non-muscle-invasive. It is approved with chemotherapy for stomach and gastroesophageal junction cancers that can be removed with surgery, too.

Currently, Imfinzi does not have FDA approval to treat mesothelioma. However, some mesothelioma patients may receive this drug through clinical trials.

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How Does Imfinzi (Durvalumab) Treat Mesothelioma?

Imfinzi works by allowing the immune system to recognize and attack cancer cells. Healthy cells have proteins that can “shake hands” with a specific protein on an immune cell. This interaction is called an immune checkpoint. When the healthy cell and immune cell complete this handshake, the immune cell knows not to attack the healthy cell. But cancer cells can also use immune checkpoints to hide from immune cells. Imfinzi blocks the checkpoint. Once the checkpoint is blocked, immune cells can attack cancer cells.

Imfinzi is similar to two other immunotherapy drugs, Opdivo® (nivolumab) and Keytruda. All three drugs target the PD-1/PD-L1 immune checkpoint, which cancer cells can use to avoid an immune attack. Opdivo works the same way as Keytruda, by blocking PD-1.

Imfinzi has been tested in combination with the immunotherapy drug Imjudo® (tremelimumab). Researchers have also investigated Imfinzi in combination with chemotherapy drugs in three clinical trials called DREAM, PrE0505 and DREAM3R.

Currently, Imfinzi does not have FDA approval to treat mesothelioma. Researchers have tested it in mesothelioma clinical trials.

Imfinzi (Durvalumab) and Tremelimumab for Pleural Mesothelioma

Imfinzi does not have FDA approval to treat mesothelioma. As such, it does not have a drug it is commonly associated with to treat pleural mesothelioma. However, doctors have investigated Imfinzi in a phase II clinical trial called NIBIT-MESO-1. Trial patients underwent treatment with Imfinzi and tremelimumab.

Survival results from this trial appear in the clinical trials section below.

Patients can speak with their provider to see if Imfinzi is an option for them. A mesothelioma doctor can help patients understand the drug’s potential benefits and risks.

Imfinzi (Durvalumab) for Asbestos-Related Lung Cancer

Imfinzi is FDA approved to treat qualified patients for certain lung cancers. Doctors can recommend Imfinzi for:

• ES-SCLC: Imfinzi has approval for first-line treatment of ES-SCLC. It is approved for use with etoposide and either carboplatin or cisplatin.
• NSCLC: Imfinzi has FDA approval for the treatment of adults with unresectable (inoperable) stage 3 NSCLC. Doctors may recommend Imfinzi for patients whose cancer has not progressed after platinum-based chemotherapy given at the same time as radiation therapy.

Imfinzi is also approved for limited-stage small cell lung cancer after chemoradiation. It is approved for metastatic NSCLC when given with tremelimumab and chemotherapy. Doctors may also use it before and after surgery for NSCLC that can be removed.

Asbestos exposure can cause lung cancer and other types of cancer. A doctor may determine that treatment with Imfinzi is an option for some patients. Patients can discuss any treatment options with their doctor.

Did You Know? Some treatments for mesothelioma are not covered by insurance. Treatment for mesothelioma can become a financial burden. Learn More About Financial Assistance Available

What to Expect During Treatment

There is no standard Imfinzi treatment for mesothelioma. However, patients may expect an experience similar to the procedures used in clinical trials. The phase II NIBIT-MESO-1 trial tested Imfinzi and tremelimumab in patients with mesothelioma. During the trial, patients went through two separate phases.

The first phase was called the induction phase. It involved treatment with Imfinzi and tremelimumab. Patients received 1 milligram of tremelimumab per kilogram of body weight. They also received 20 milligrams of Imfinzi per kilogram of body weight. Doses of each drug were given intravenously every four weeks for four doses.

The second phase was a maintenance phase. Patients received Imfinzi alone at a dose of 20 milligrams per kilogram of body weight. They received the drug intravenously every four weeks for up to nine additional doses.

Researchers said infusions took roughly one hour to complete. Treatment stopped if:

• The doctors chose to suspend it
• The patient chose to withdraw
• The patient experienced disease progression
• The patient had unacceptable side effects

During treatment, doctors monitored study patients with routine laboratory tests. These tests help monitor a patient’s response to treatment.

Preparing for Your Appointment

Before beginning immunotherapy, patients may want to talk to their doctors about preparing their bodies and immune systems for treatment. Each cancer center may have different guidelines for what patients should do before they begin treatment. However, general guidelines include:

• Eat well: Following a healthy diet may give the patient the energy they need for treatment. The healthcare team may also recommend avoiding alcohol.
• Exercise: The healthcare team may encourage patients to stay active before and during treatment.
• Quit smoking: Patients may want to talk with their healthcare team about smoking cessation programs. Quitting smoking may help the patient.
• Sleep well: A good night’s sleep may help decrease any strains on the immune system.

On the day of the first infusion, patients may want to arrange for transportation until they know how they will react to the treatments. Patients can discuss concerns about their specific treatment with their healthcare team.

Before starting immunotherapy, patients should tell their doctor about any autoimmune disease, organ or stem cell transplant, breathing problems or liver disease. They should also tell their doctor if they are pregnant or breastfeeding, according to Fox Chase Cancer Center.

Imfinzi (Durvalumab) Side Effects

All cancer treatments have the potential to cause side effects. Imfinzi and other checkpoint inhibitors may cause reactions because of their effects on the immune system. Side effects will also vary from person to person and depend on multiple factors.

Imfinzi allows T cells to attack other cells they would normally ignore. As a result, the T cells can attack cancer cells. However, the T cells may also attack healthy cells.

If this happens, it may produce symptoms similar to those of an autoimmune condition. Such side effects are called immune-related adverse events. Doctors may pause or stop the treatment if severe immune-related adverse events appear.

The FDA label warns that these attacks can inflame the lungs (pneumonitis), colon (colitis), liver (hepatitis), kidneys and hormone glands. Some of these reactions can be severe.

In the NIBIT-MESO-1 trial, 75% of patients had at least one side effect linked to Imfinzi and tremelimumab. Severe (grade 3 or 4) side effects affected 18%. Three of the 40 patients (8%) stopped treatment because of severe side effects. Overall, researchers found that most side effects were manageable.

Some common side effects with immunotherapy include:

• Flu-like symptoms
• Itchy skin
• Pain or soreness in joints and muscles
• Rashes or redness
• Swelling

Patients can work with their healthcare team to monitor for side effects. If side effects occur, doctors can help patients manage them.

Managing Side Effects

Patients may experience side effects during Imfinzi treatment or after it ends. They should tell their cancer care team about any new or worsening symptoms as soon as they appear. Some immune-related side effects can be serious and require prompt medical attention.

Side effects can range from mild to severe. The care team will monitor patients throughout treatment.

If side effects appear, the care team may choose to pause treatment to give the patient’s body time to heal. Severe side effects may mean patients need to stop treatment completely. A doctor can help patients manage side effects, but the doctor and patient generally work together to identify them.

Who Is Eligible for Imfinzi (Durvalumab)?

Imfinzi does not have FDA approval to treat mesothelioma. Thus, eligibility criteria for mesothelioma patients have not yet been determined. To be eligible, patients may need to qualify for a clinical trial that includes Imfinzi treatment.

Australia has taken a different path. Its Therapeutic Goods Administration (TGA) has given Imfinzi provisional approval for epithelioid pleural mesothelioma that cannot be removed with surgery. Imfinzi is used with pemetrexed and platinum chemotherapy. The decision rested on two phase II trials. Continued approval depends on a confirmatory trial.

Adult patients may be eligible for Imfinzi treatment of some lung cancers. This includes stage 3 NSCLC that is not eligible for surgery. To be eligible for Imfinzi, these patients should have completed platinum-based chemotherapy given at the same time as radiation therapy. Imfinzi may be used following these treatments if the cancer has not progressed.

Some adult patients may be eligible if they have ES-SCLC. The approved treatment includes a combination of Imfinzi, etoposide and either carboplatin or cisplatin.

Clinical Trials and Studies on Imfinzi (Durvalumab) for Mesothelioma

Clinical trials of Imfinzi for mesothelioma have shown activity against the cancer, but no randomized trial has proven that it helps patients live longer.

Researchers first reported results of the phase II NIBIT-MESO-1 trial of Imfinzi and tremelimumab in 2018. The trial enrolled 40 participants between October 2015 and October 2016. It included patients with pleural or peritoneal mesothelioma that could not be surgically treated.

Patients had a median survival of 16.5 months, according to a 2021 update in The Lancet Respiratory Medicine. About 15% of patients were alive four years after starting treatment. The trial included patients with different cell types, including epithelioid mesothelioma and biphasic mesothelioma.

After an initial round of the two drugs, eligible patients could receive a second treatment. Patients whose cancer had first shrunk or held steady could receive Imfinzi and tremelimumab again when it grew. Some other patients received chemotherapy instead. Researchers compared survival between these groups, but the comparison was not randomized. Results included:

• Chemotherapy instead of retreatment (15 patients): Median survival of 11 months from the start of the trial
• Retreatment with Imfinzi and tremelimumab (17 patients): Median survival of 25.6 months from the start of the trial

Earlier phase II trials tested Imfinzi with pemetrexed and platinum chemotherapy as a first treatment for pleural mesothelioma. In the PrE0505 trial of 55 patients, median survival was 20.4 months, according to a 2021 report in Nature Medicine. Patients with epithelioid mesothelioma had a median survival of 24.3 months.

The phase III DREAM3R trial compared Imfinzi plus chemotherapy with chemotherapy alone as a first treatment for pleural mesothelioma. The chemotherapy was pemetrexed with cisplatin or carboplatin. The trial stopped early because too few patients enrolled.

Results presented at the 2025 European Society for Medical Oncology (ESMO) Congress showed a median survival of 21 months with Imfinzi plus chemotherapy and 18 months with chemotherapy alone. This difference was not statistically significant. Tumors shrank in 58% of patients who received Imfinzi plus chemotherapy, compared with 35% of those who received chemotherapy alone. This difference was statistically significant.

Since the trial began, Opdivo plus Yervoy® (ipilimumab) has become a standard first treatment for pleural mesothelioma. Chemotherapy alone is no longer the usual comparison. The trial leaders said the question it asked is unlikely to ever be answered.

Patients interested in taking part in a clinical trial can discuss it with their doctors.