Imfinzi (Durvalumab)

Durvalumab is an immunotherapy treatment for bladder cancer and lung cancer. It is marketed under the brand name Imfinzi and manufactured by AstraZeneca. Durvalumab helps the immune system fight cancer, and clinical trials are testing it on a variety of diseases, including mesothelioma.

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This page features: 11 cited research articles

Durvalumab was approved by the U.S. Food and Drug Administration (FDA) in May 2017 to treat late-stage bladder cancer. It is approved specifically to treat a form of bladder cancer called urothelial carcinoma when it cannot be removed by surgery and has recurred after chemotherapy.

Clinical trials have tested the drug on patients with mesothelioma, lung cancer, melanoma, pancreatic cancer, gastric cancer, head and neck cancer, esophageal cancer, lymphoma, myelodysplastic syndrome and solid tumors.

The best results in these trials occurred in lung cancer patients.

A phase III clinical trial of durvalumab for stage 3 lung cancer patients reported the drug stopped tumor growth for an average of 11 months. Some patients showed no new tumor growth after chemotherapy and radiation therapy.

In July 2017, the FDA designated durvalumab as a breakthrough therapy, which expedites the development and review of the drug. In February 2018, the FDA approved Durvalumab for lung cancer treatment.

Promising results in lung cancer patients led to clinical trials testing durvalumab in the mesothelioma population.

In 2015, an Italian phase II trial began testing durvalumab in combination with tremelimumab on mesothelioma patients who did not qualify for surgery.

Around 62 percent of participants responded to durvalumab and tremelimumab, but the study failed to improve survival. Doctors leading the study said more research is necessary.

Several clinical trials in the U.S. and abroad are evaluating the effects of durvalumab in people with mesothelioma.

How Does Durvalumab Work?

Durvalumab — like the immunotherapy drug Keytruda — is a checkpoint inhibitor that blocks PD-L1.

PD-L1 is a protein on the surface of cancer cells that works like a mask to hide cancer from the immune system.

Durvalumab blocks PD-L1 and essentially removes the mask so the immune system can identify and attack cancer cells.

Drug Fast Facts

Durvalumab Information

Name

Durvalumab

Alternate Names

ImFinzi, MEDI4736

Manufacturer

AstraZeneca

Dosage

10 mg/kg

Administration Route

IV

Active Ingredient

Durvalumab

Drug Class

Checkpoint inhibitor, monoclonal antibody

Medical Code

C9492

Interacting Drug

Vaccines, vitamin E, zinc, cat’s claw, echinacea

Medical Studies

A Phase 2 Study of durvalumab in Combination with Tremelimumab in Malignant Pleural Mesothelioma

FDA Warning

Pneumonitis, liver disease, colitis, kidney inflammation, endocrine gland disease, infection, infusion reactions, fetal harm

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Durvalumab Side Effects

Durvalumab stimulates the immune system and may cause it to attack healthy organs and tissues. Side effects range from mild to severe.

Mild side effects include:

  • Fatigue
  • Bone and muscle pain
  • Constipation
  • Loss of appetite
  • Nausea
  • Swelling in arms or legs
  • Urinary tract infection
  • Fever
  • Abdominal pain
  • Diarrhea

Other mild side effects include reduced sodium in the blood and low white blood cell count.

Serious side effects of durvalumab include:

  • Infections
  • Liver disease
  • Inflammation in the lungs
  • Kidney problems
  • Inflammation of the colon lining
  • Difficulty breathing
  • Skin problems (rash, itching and blisters)
  • Infusion-related reactions
  • Damage to hormone glands (thyroid, adrenals, pituitary and pancreas)

Signs of severe infusion reactions include chills or shaking, flushing, itching or rash, wheezing or shortness of breath, fever, dizziness or lightheadedness, facial swelling and back or neck pain.

Talk to your doctor immediately if you notice any mild or serious side effects. Seek medical treatment quickly to keep side effects under control.

Research on Durvalumab in Mesothelioma Treatment

Nearly all clinical trials of durvalumab involving mesothelioma patients are too new to produce results.

Only the Italian study that began in 2015 has published early results, which proved the drug was effective against mesothelioma but did not improve survival.

Other clinical trials began in 2016 and 2017.

  • In 2016, the Lung Institute at Baylor College of Medicine in Houston opened a trial that combines durvalumab with the immunotherapy drug tremelimumab. Participants in this trial, which is overseen by mesothelioma expert Dr. David Surgarbaker, must qualify for surgery.

  • Dana-Farber Cancer Institute in Boston began a phase II clinical trial in April 2017 that combines durvalumab and tremelimumab among patients who do not qualify for mesothelioma surgery.

  • A nationwide phase II trial began in June 2017 that combines durvalumab with chemotherapy as a first-line treatment for mesothelioma patients who do not qualify for surgery. The Seattle Cancer Care Alliance, a renowned mesothelioma treatment center, is participating in the trial.

Mesothelioma survivor and Navy veteran Jim McWhorter participated in Dana-Farber’s durvalumab clinical trial, and he initially responded well. His cancer stopped growing for several months. Then a CT scan showed the cancer was growing again, and McWhorter had to leave the trial in search of other options.

Research shows durvalumab works for many people with mesothelioma, but usually only for a period of time. Durvalumab may not be a cure for mesothelioma, but research is underway to investigate the roles it might play in controlling the cancer and improving survival.

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Karen Selby, RN and Patient Advocate at The Mesothelioma Center

Karen Selby joined Asbestos.com in 2009. She is a registered nurse with a background in oncology and thoracic surgery and was the director of a tissue bank before becoming a Patient Advocate at The Mesothelioma Center. Karen has assisted surgeons with thoracic surgeries such as lung resections, lung transplants, pneumonectomies, pleurectomies and wedge resections. She is also a member of the Academy of Oncology Nurse & Patient Navigators. Read More

Matt Mauney, Content Writer at Asbestos.com

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Last Modified August 16, 2018
Sources
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  6. AstraZeneca. (2017, October 17). US FDA accepts supplemental Biologics License Application for Imfinzi in locally advanced unresectable non-small cell lung cancer.
    Retrieved from: https://www.astrazeneca.com/media-centre/press-releases/2017/us-fda-accepts-supplemental-biologics-license-application-for-imfinzi-in-locally-advanced-unresectable-non-small-cell-lung-cancer-171017.html
  7. Calabro, L. et al. (2017). Tremelimumab in combination with durvalumab in first or second-line mesothelioma patients: Safety analysis from the phase II NIBIT-MESO-1 study.
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    Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf#page=19
  10. ClinicalTrials.gov. (2018, January 19). A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma.
    Retrieved from: https://www.clinicaltrials.gov/ct2/show/NCT03075527
  11. ClinicalTrials.gov. (2015, October 27). A Study of Tremelimumab Combined With the Anti-PD-L1 MEDI4736 Antibody in Malignant Mesothelioma (NIBIT-MESO-1).
    Retrieved from: https://www.clinicaltrials.gov/ct2/show/NCT02588131
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