Imfinzi (Durvalumab)

What is Imfinzi?

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 urothelial carcinomas when they cannot be removed by surgery and have 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, expediting the drug’s development and review. In February 2018, the FDA approved Durvalumab for lung cancer treatment.

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

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

Around 62% 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. A new trial launched in February 2022 will recruit 480 patients (320 durvalumab and chemotherapy, 160 chemotherapy) over 27 months and follow them for another 24 months.

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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.

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

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.

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

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 severe 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.

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 that durvalumab works for many people with mesothelioma, but usually only for some time. Durvalumab may not be a cure for mesothelioma, but research is underway to investigate its roles in controlling the cancer and improving survival.