Imfinzi (Durvalumab)

What Is Imfinzi (Durvalumab)?

The U.S. Food and Drug Administration approved immunotherapy drug Imfinzi (Durvalumab) in May 2017 to treat late-stage bladder cancer. It’s approved specifically to treat urothelial carcinomas when they can’t be removed with surgery and have recurred after chemotherapy.

Clinical trials have tested the drug on patients with a variety of cancers including 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.

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

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, expediting the drug’s development and review. In February 2018, the FDA approved durvalumab for lung cancer treatment.

How Does Durvalumab Work?

Durvalumab is a checkpoint inhibitor that blocks PD-L1. It’s in the same class as the immunotherapy drug Keytruda. Checkpoint inhibitors boost the body’s natural defenses against cancer cells.

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 removes the mask so the immune system can identify and attack cancer cells. About 50% of mesothelioma cells carry high amounts of PD-L1 to hide from the immune system. Doctors often test patients for this protein to check if durvalumab will be effective in their treatment.

Our research shows doctors often combine durvalumab with traditional mesothelioma treatments such as surgery and chemotherapy with platinum-based drugs. Immunotherapy drugs are typically effective after chemotherapy stops working or when cancer returns.

Side Effects of Imfinzi (Durvalumab) for Mesothelioma

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

Other mild side effects include reduced sodium in the blood and low white blood cell count. Doctors can prescribe medication to treat most mild to moderate side effects of durvalumab.

Serious Side Effects of Imfinzi (Durvalumab)

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

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

Can Imfinzi Treat Mesothelioma?

Promising results in lung cancer patients led to clinical trials testing durvalumab in patients with mesothelioma. A trial launched in February 2022 is recruiting 480 patients (320 durvalumab and chemotherapy, 160 chemotherapy) over 27 months and following them for another 24 months.

Dana-Farber Cancer Institute in Boston also conducted a phase II clinical trial in April 2017 that tested testing durvalumab and tremelimumab among patients who don’t qualify for mesothelioma surgery. Mesothelioma survivor and Navy veteran Jim McWhorter participated in Dana-Farber’s clinical trial, and he initially responded well. His cancer stopped growing for several months. Then, a CT scan showed the tumor was growing again, and McWhorter had to leave the trial in search of other options.

In 2015, an Italian phase II trial began testing durvalumab and tremelimumab on mesothelioma patients who didn’t qualify for surgery. Around 62% of participants responded to durvalumab and tremelimumab, but the immunotherapy study failed to improve survival. Doctors leading the study said more research is necessary.

Jim McWhorter

Verified Asbestos.com Survivor

Navy Veteran Pursues Mesothelioma Immunotherapy Trials

Jim was able to get into a clinical trial at Dana-Farber Cancer Institute in Boston, testing a combination of the immunotherapy drugs durvalumab and tremelimumab. For the first few months, the results were extremely positive. The cancer had stabilized.

Jim McWhorter

Verified Asbestos.com Survivor

Read Jim’s Story

Are All Mesothelioma Patients Eligible for Imfinzi (Durvalumab)?

Mesothelioma patients who have a high rate of PD-L1 tumor mutation are eligible for durvalumab. Patients must also have had cancer return after trying prior treatment. About 20% to 40% of pleural mesothelioma patients express high levels of PD-L1. This protein is also more common in non-epithelial mesothelioma tumors.

The FDA is reviewing the combination of durvalumab with chemotherapy for patients with a new mesothelioma diagnosis. Durvalumab is currently available as a second-line treatment for late-stage mesothelioma and through clinical trials with varying eligibility requirements. Surgery, chemotherapy and radiation therapy in a multimodal treatment plan is still the standard of care for the first-line treatment of early-stage mesothelioma.

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