Durvalumab Clinical Trials
Page Medically Reviewed and Edited by Kyle J. Becker, PharmD, MBA, BCOPThis page has been fact checked by a Doctor of Pharmacy who specializes in Oncology. Sources of information are listed at the bottom of the article.
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Durvalumab (Imfinzi) is one of several new immunotherapy drugs currently being tested to treat mesothelioma and other types of cancers. This new treatment works by taking the brakes off immune cells, helping them to identify, 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 treatment of bladder cancer and non-small cell lung cancer, although 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 that act as checkpoints in the process. When a T-cell interacts with another cell, they usually recognize that cell as healthy, and therefore leave it alone. Many cancer cells also have these proteins on their surfaces, essentially tricking the T-cells into thinking they are normal and healthy.
Checkpoint inhibitors like durvalumab work to stop that protein interaction. This leads the T-cells to recognize cancer cells as harmful and begin attacking. Durvalumab specifically targets the protein on cancer cell surfaces called PD-L1. In 2017, the U.S. Food and Drug Administration (FDA) 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 functions in cancers that expresses this protein. In many patients, mesothelioma can overexpress PD-L1, making the disease a good candidate for testing with durvalumab.
Clinical Trials for Durvalumab Mesothelioma
Positive results in clinical trials of durvalumab for 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 could 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 the safety and effectiveness of this treatment combination. While the trial is not currently recruiting additional participants, the results could lead to a phase three trial for additional data or an accelerated approval.
The Dana-Farber Cancer Institute in Boston presented results from a phase II clinical trial of durvalumab in mesothelioma. This trial was testing the combination of durvalumab with another immunotherapy drug called tremelimumab. These two drugs work in similar ways and have been previously tested alone. Trial participants had pleural mesothelioma that cannot be treated with surgery. While researchers hoped the combination would be more effective than either drug used independently, the study failed to meet its primary endpoint at the time of interim analysis, and so it was closed early.
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 greater risk for upper respiratory infections.
Adverse events for patients being treated for mesothelioma have not yet been noted. 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 could differ.
While there is still hope that clinical trial results will show this immunotherapy drug has great potential to help people with pleural mesothelioma, clear results have yet to bring any approvals. Durvalumab may eventually 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 other investigative treatment, let us help connect you with the experts who can determine if you qualify.
Page Medically Reviewed and Edited by Kyle J. Becker, PharmD, MBA, BCOP
Kyle J. Becker, PharmD is certified by the Board of Pharmacy Specialties in Oncology Pharmacy. Dr. Becker earned his pharmacy degree from Shenandoah University and he currently serves as an oncology pharmacist at Parkview Cancer Institute.
