Imjudo® (Tremelimumab) for Mesothelioma
Imjudo® (tremelimumab) is an immunotherapy drug approved for some liver and lung cancers but not for mesothelioma. In a phase II trial of 40 mesothelioma patients, those given Imjudo plus Imfinzi® (durvalumab) lived a median of 16.5 months, though the trial had no comparison group.
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What Is Imjudo (Tremelimumab)?
Imjudo® (tremelimumab) is a checkpoint inhibitor, which is a type of immunotherapy drug. It uses the patient’s immune system to recognize and attack cancer cells. Other checkpoint inhibitors similar to Imjudo have shown encouraging results in treating mesothelioma. This makes Imjudo a possible area of interest for future mesothelioma research.
- Generic name: Tremelimumab is the generic name for Imjudo. The FDA label lists it as tremelimumab-actl.
- Brand name: Imjudo is the brand name for tremelimumab.
- Administration: Imjudo is administered intravenously as a 60-minute infusion.
- Drug combinations: Imjudo is given with Imfinzi® (durvalumab) in its approved uses and in most mesothelioma studies. For lung cancer, it is also combined with platinum chemotherapy.
- Types of mesothelioma treated: Imjudo has been studied in clinical trials for pleural mesothelioma, peritoneal mesothelioma, epithelioid mesothelioma, biphasic mesothelioma and sarcomatoid mesothelioma.
- Manufacturer: Imjudo is manufactured by AstraZeneca.
- FDA approval: Imjudo is not FDA approved to treat mesothelioma. It is approved with Imfinzi to treat unresectable hepatocellular carcinoma (liver cancer). It is also approved with Imfinzi and platinum chemotherapy to treat metastatic non-small cell lung cancer (NSCLC). The FDA granted Imjudo orphan drug designation for mesothelioma in 2015, which supports development but is not an approval.
Immunotherapy is a promising treatment for mesothelioma. Research into the effectiveness of different immunotherapy drugs for mesothelioma is ongoing.
The U.S. Food and Drug Administration (FDA) has approved the immunotherapy combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) to treat some cases of pleural mesothelioma. In September 2024, the FDA also approved Keytruda® (pembrolizumab) with chemotherapy for pleural mesothelioma that cannot be removed with surgery. Opdivo, Yervoy and Keytruda are checkpoint inhibitors like Imjudo. These drugs help the immune system fight cancer by blocking different immune checkpoint proteins.
Imjudo is not yet approved by the FDA to treat mesothelioma, but researchers are still studying it. Mesothelioma patients may start receiving Imjudo if it is proven to be a safe and effective treatment.
How Does Imjudo (Tremelimumab) Treat Mesothelioma?
Imjudo blocks cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a protein that acts as a brake on immune cells called T cells. Releasing that brake can help the immune system attack cancer cells. Imjudo is a checkpoint inhibitor, which is a type of monoclonal antibody treatment. Early studies point to its possible benefits as a mesothelioma treatment.
Imjudo may help the body’s immune system detect and destroy cancer cells. It can do this by interfering with immune checkpoints that help cancer cells avoid being attacked by the immune system.
T cells are immune cells that can recognize and attack harmful cells or materials in the body. Immune checkpoints are safeguards that help keep T cells from attacking healthy cells. But cancer cells can also use immune checkpoints to avoid T-cell attacks.
Checkpoint inhibitors block immune checkpoints, allowing T cells to recognize and attack cancer cells. Imjudo interferes with an immune checkpoint called CTLA-4. This interference prevents cancer cells from using this checkpoint to avoid detection and destruction by T cells.
Early research indicates Imjudo combined with Imfinzi may help treat mesothelioma. Imfinzi is another checkpoint inhibitor. It blocks a different checkpoint protein called PD-L1. Together, Imjudo and Imfinzi block the same two pathways as Yervoy and Opdivo, although Opdivo targets PD-1 rather than PD-L1. The FDA has approved Yervoy plus Opdivo to treat malignant pleural mesothelioma. Researchers hope to find comparable treatment benefits with Imjudo plus Imfinzi.
Did You Know?
Some treatments for mesothelioma are not covered by insurance.
Treatment for mesothelioma can become a financial burden.
What to Expect During Treatment
There is no standard mesothelioma treatment with Imjudo. Researchers have yet to fully explore its possible mesothelioma treatment applications. It is still considered an experimental therapy for mesothelioma.
Researchers have tested Imjudo in several mesothelioma studies, both alone and with Imfinzi. The best-known combination study is the phase II NIBIT-MESO-1 trial. Study patients had inoperable pleural or peritoneal mesothelioma. They received Imjudo in combination with Imfinzi. Both drugs were administered through intravenous infusion.
Patients in this mesothelioma study received treatment in two or three stages:
- Induction: This stage used both Imjudo and Imfinzi. Patients received this infusion every four weeks for four cycles of treatment.
- Maintenance: This stage used only Imfinzi as a form of maintenance therapy. This stage lasted for nine four-week cycles.
- Retreatment: Patients could repeat the full course if their cancer first shrank or held steady and then grew again. They still had to meet the eligibility rules.
Future studies may explore different ways to use Imjudo for mesothelioma treatment.
Imjudo treatment for metastatic non-small cell lung cancer (NSCLC) has two stages, according to the FDA-approved label.
- First four cycles: Patients receive Imjudo, Imfinzi and platinum-based chemotherapy every three weeks for four cycles.
- Maintenance: Patients then receive Imfinzi every four weeks. Some also receive pemetrexed chemotherapy, depending on their type of lung cancer. A fifth and final dose of Imjudo is given with the sixth Imfinzi dose at week 16. Imfinzi continues until the cancer grows or side effects become too severe.
For unresectable liver cancer, patients receive a single dose of Imjudo with Imfinzi on the same day. They then receive Imfinzi alone every four weeks.
Doctors may recommend stopping treatment if a patient experiences severe side effects. Patients should report all side effects to the treatment team as soon as possible.
Preparing for Your Appointment
Patients can prepare for their immunotherapy appointment. For example, actions that may support immune function and help them feel their best during treatment include:
- Eating well: Good diet and nutrition may help maintain energy needed for treatment. Patients should ask their treatment team whether they need to avoid alcohol or make other dietary changes.
- Exercising: Staying active may have positive effects on the immune system and can help patients maintain strength and manage fatigue. Patients should ask their treatment team what level of activity is appropriate.
- Sleeping well: Good sleeping habits may help boost the immune system and help patients manage treatment-related fatigue.
Patients may also want to arrange transportation from the treatment center. This is especially important for the first appointment, as patients may not know how the treatment will affect them. Transportation services may be available if a friend or family member cannot provide a ride.
Treatment with immune checkpoint inhibitors may require different preparation than chemotherapy. Certain chemotherapy pretreatment preparations, such as intravenous hydration, may not be necessary.
Cancer centers may have their own preparation guidelines for patients receiving checkpoint inhibitors. A healthcare provider can walk patients through any guidelines. They can also answer any other questions patients have about appointment preparation.
Imjudo (Tremelimumab) Benefits
The main potential benefit of Imjudo for mesothelioma is longer survival when it is combined with Imfinzi. That benefit has not yet been shown in a randomized trial. Future studies could help establish a useful treatment regimen using this immunotherapy drug.
The NIBIT-MESO-1 trial tested the Imjudo and Imfinzi combination in 40 patients, who received it as either their first or second treatment. All study patients received several cycles of Imjudo and Imfinzi. This was followed by maintenance therapy with only Imfinzi.
Some patients then underwent repeat treatment with Imjudo and Imfinzi. Patients ineligible for repeat treatment received chemotherapy. Researchers later compared the two groups. Median overall survival, counted from the start of the trial, was:
- Chemotherapy group: 11 months
- Imjudo and Imfinzi retreatment group: 26 months
Measured from the start of retreatment, median survival for retreated patients was 12.5 months. Historical second-line treatments for pleural mesothelioma achieved a survival of about 8 months. These results are encouraging, but they come from one small study without a randomly assigned comparison group. Future research may show improved survival for mesothelioma patients who receive similar treatment.
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Imjudo (Tremelimumab) Side Effects
Patients receiving Imjudo for malignant mesothelioma may experience treatment side effects. In the DETERMINE trial of Imjudo alone, the most common side effects were diarrhea, shortness of breath and colitis, which is inflammation of the colon. Possible effects from a combination of Imjudo and Imfinzi are listed below.
- Abdominal pain
- Anemia
- Diarrhea
- Fatigue
- Itching
- Liver enzyme changes
- Low platelet counts
- Low white blood cell counts
- Muscle and bone pain
- Nausea
- Pancreas enzyme changes
- Psoriasis
- Skin rash
- Thyroid disorders
- Vomiting
*These side effects occurred in patients receiving Imjudo and Imfinzi for mesothelioma or liver cancer.
Imjudo with Imfinzi is FDA approved for liver cancer. In that use, the most common side effects are muscle and bone pain, rash, diarrhea, fatigue, itching and abdominal pain, according to the FDA label.
Patients treated with Imjudo and Imfinzi may also experience immune-related adverse events (irAEs). These reactions happen when a patient’s immune system attacks healthy tissue, and they can be serious. Doctors can watch for signs of irAEs during treatment. In the NIBIT-MESO-1 trial, 75% of patients had treatment-related side effects of any kind. Severe (grade 3 or 4) side effects affected 18%.
Managing Side Effects
Imjudo is still an experimental drug for mesothelioma treatment. As such, its side effects and their management are less documented for mesothelioma than for liver or lung cancer.
In the NIBIT-MESO-1 trial, side effects were generally manageable and reversible. Some patients stopped treatment because of immune-related side effects. According to the FDA label, doctors manage these side effects by:
- Pausing or stopping Imjudo and Imfinzi
- Prescribing steroids or other drugs that calm the immune system
- Prescribing hormone replacement when immune-related side effects affect the thyroid or other hormone-producing glands
Patients should speak to their healthcare team about any side effects they experience. A mesothelioma doctor can determine how to best address side effects.
Who Is Eligible for Imjudo (Tremelimumab)?
Mesothelioma patients may receive Imjudo through a clinical trial, because it is not FDA approved for mesothelioma. Each trial sets its own eligibility rules. Future research can help determine Imjudo eligibility requirements.
In the NIBIT-MESO-1 trial of Imjudo and Imfinzi, eligibility requirements included:
- Adequate ability to engage in daily activity, also called performance status
- Adequate organ function
- Life expectancy of at least three months
Patients deemed ineligible to participate in the study included those with:
- Autoimmune disease
- Brain metastases that cause symptoms or need treatment
- Previous checkpoint inhibitor treatment targeting the same immune checkpoints
These requirements will not necessarily be the same for every clinical trial.
Clinical Trials and Studies on Imjudo (Tremelimumab) for Cancer Treatment
Imjudo has been approved to treat two types of cancer: unresectable hepatocellular carcinoma and non-small cell lung cancer. Studies into other possible uses are ongoing. In general, immunotherapy is a promising type of mesothelioma treatment. Immunotherapy drugs have the potential to improve mesothelioma prognosis.
One clinical trial looked at the potential use of Imjudo alone to treat relapsed mesothelioma. This trial, called DETERMINE, included 571 patients. Median overall survival was 7.7 months with Imjudo and 7.3 months with a placebo, which researchers found was not a meaningful difference.
The NIBIT-MESO-1 trial tested Imjudo and Imfinzi together. The study initially enrolled 40 patients with pleural or peritoneal mesothelioma. Some study patients had already received first-line treatment with chemotherapy.
After four years of follow-up, median overall survival for all 40 patients was 16.5 months. About 20% of patients were alive at 3 years and 15% at 4 years, according to a 2021 report in The Lancet Respiratory Medicine.
Patients first went through several cycles of Imjudo and Imfinzi infusions. They then received maintenance treatment with Imfinzi. Ultimately, 17 patients underwent retreatment with Imjudo and Imfinzi. Other patients who did not qualify for retreatment received chemotherapy.
Retreated patients lived a median of about 26 months from the start of the trial, compared with 11 months for patients who received chemotherapy instead. However, only patients whose cancer had responded to the first course could be retreated, so the two groups were not alike.
The 2025 ASCO guideline update for pleural mesothelioma reviewed these retreatment results. It noted that no retreated patient had tumor shrinkage, while 41% had stable disease.
Research into checkpoint inhibitors for mesothelioma is a developing area of study. Future research may provide more evidence about the safety and effectiveness of tremelimumab for the treatment of mesothelioma.
A trial at Baylor College of Medicine is testing Imjudo and Imfinzi, with or without chemotherapy, before surgery for pleural mesothelioma. It is expected to finish in 2028.
Common Questions About Imjudo (Tremelimumab) for Mesothelioma
Is Imjudo FDA approved for mesothelioma?
How long do mesothelioma patients live on Imjudo and Imfinzi?
Does Imjudo work on its own for mesothelioma?
Sources
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Dr. Francis Perry Wilson is the Director of the Clinical and Translational Research Accelerator at the Yale University School of Medicine. He specializes in nephrology and clinical research.
Liza Adelberg has more than 20 years of experience in marketing and communications. At Mesothelioma.com, she creates clear, compassionate resources for patients and families affected by asbestos-related diseases.
