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Durvalumab Clinical Trials

Durvalumab is one of several new immunotherapy drugs currently being tested to treat mesothelioma and other types of cancers. This new drug essentially works by taking the brakes off immune cells, allowing them to attack and destroy cancer cells. This is a targeted therapy that may only work for cancers that express a specific protein. Currently, durvalumab is approved for bladder cancer and non-small cell lung cancer, though it is now being studied in several clinical trials with mesothelioma patients.

Durvalumab (Imfinzi)

Durvalumab is made by AstraZeneca and used under the brand name Imfinzi. This new drug is known as a checkpoint inhibitor.

Immune system T-cells are responsible for attacking and destroying harmful cells. However, that action can be blocked by interactions between proteins on cell surfaces. T-cells and healthy cells have proteins on their surfaces. These proteins act as checkpoints. When T-cell interact with another cell, they usually recognize that cell as healthy, and therefore leave it alone. Many cancer cells also have these checkpoints on their surfaces, essentially tricking T-cells into thinking they are normal and healthy.

Checkpoint inhibitors like durvalumab work to stop that protein interaction. This allows T-cells to recognize cancer cells as harmful, resulting in an attack. Durvalumab specifically targets a protein on cancer cell surfaces called PD-L1. In 2017, the U.S. Food and Drug Administration approved durvalumab to treat bladder cancer. In 2018, durvalumab was also approved to treat non-small cell lung cancer not treatable by surgery.

Durvalumab and Mesothelioma

A drug like durvalumab will not work for every type of cancer. Not all cancer cells express the same surface proteins. Durvalumab specifically acts on PD-L1, so it only works on cancers that over-express this protein. In many patients, mesothelioma over-expresses PD-L1, and is therefore a good candidate for testing with durvalumab.

Clinical Trials for Durvalumab Mesothelioma

Successful clinical trials of durvalumab in patients with bladder or non-small cell lung cancer led to approval of the drug. Mesothelioma is now being tested in similar clinical trials. If treatment in these clinical trials proves safe and effective, durvalumab may be approved to treat this rare and aggressive cancer.

Currently, there is one clinical trial of durvalumab for mesothelioma in phase II. This trial is testing a combination of durvalumab with chemotherapy. Patients involved in this specific clinical trial have pleural mesothelioma that cannot be treated surgically. The purpose is to explore safety and effectiveness of this treatment combination. While the trial is not currently accepting new participants, if results are promising, a third phase will require more mesothelioma patients.

The Dana-Farber Cancer Institute in Boston is currently conducting a phase II clinical trial of durvalumab. This trial is testing the combination of durvalumab with another immunotherapy drug called tremelimumab. These two drugs work in similar ways and have been used alone previously. Trial participants have pleural mesothelioma that cannot be treated with surgery. Researchers are hoping the combination will be more effective than either drug used independently.

Potential Side Effects

Like other cancer drugs, durvalumab may cause side effects in patients. The most common side effects include fatigue, pain, lowered appetite, constipation, nausea, cough, skin rashes, and peripheral edema. Some patients with bladder cancer who were treated with durvalumab developed urinary tract infections. Those with lung cancer were at risk of upper respiratory infections.

Adverse events for patients being treated for mesothelioma have not yet been recorded. The risks are likely similar to side effects seen in patients being treated with durvalumab for lung cancer or bladder cancer. However site-specific infections will obviously differ.

So far, clinical trial results show this immunotherapy drug has great potential to help people with pleural mesothelioma. Durvalumab may become an approved treatment, but ongoing clinical trials are needed. There are currently no trials in phase III, so approval of the drug will take time.  If you are interested in participating in a trial with durvalumab, or any new investigative treatment, let us help connect you with the experts who can determine if you qualify.

Page Edited by Dave Foster

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Dave has been a mesothelioma Patient Advocate for over 10 years. He consistently attends all major national and international mesothelioma meetings. In doing so, he is able to stay on top of the latest treatments, clinical trials, and research results. He also personally meets with mesothelioma patients and their families and connects them with the best medical specialists and legal representatives available. Connect with Patient Advocate Dave Foster
Sources
  1. U.S. Food and Drug Administration. (n.d.) Imfinzi. Retrieved from
    Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf
  2. National Institutes of Health. U.S. National Library of Medicine. (2018, July 9). Phase II MEDI4736 in Combination with Chemotherapy for First-Line Treatment of Unresectable Mesothelioma (PrI0505). Retrieved from
    Retrieved from: https://clinicaltrials.gov/ct2/show/NCT02899195
  3. National Institutes of Health. U.S. National Library of Medicine. (2018, November 2). A Phase 2 Study of Durvalumab in Combination with Tremelimumab in Malignant Pleural Mesothelioma. Retrieved from
    Retrieved from: https://www.clinicaltrials.gov/ct2/show/NCT03075527

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