Durvalumab (Imfinzi)

How is this drug name pronounced?

Durvalumab: dur-VAL-yoo-mab
Imfinzi: im-FIN-zee


What cancer(s) does this drug treat?

Imfinzi is approved for:

Advanced bladder and urinary tract (urothelial cell) cancer

Patients with advanced urothelial carcinoma (the most common type of bladder and urinary tract cancer) whose cancer:

  • has grown or spread, AND
  • cannot be removed by surgery, AND
  • has been treated with chemotherapy containing platinum, but it did not work or stopped working.

Advanced non-small cell lung cancer

Patients with non-small cell lung cancer whose cancer:

  • has not spread outside the chest (Stage III), AND
  • cannot be removed by surgery, AND
  • has responded to or stabilized after treatment with chemotherapy containing platinum given at the same time as radiation therapy.

Limitations of use

Age: The safety and efficacy of Imfinzi in patients under 18 years of age have not been established.
Fertility/Pregnancy/Breastfeeding: Imfinzi can cause harm to a fetus and is not recommended for use during pregnancy. Pregnancy should be prevented for at least three months after the last dose of Imfinzi. The risks associated with Imfinzi during breastfeeding are not known and cannot be ruled out. Due to the potential for serious adverse reactions in the breastfed child, women are advised not to breastfeed during treatment and for at least three months after the last dose of Imfinzi.


What type of immunotherapy is this?

Checkpoint Blockade

  • PD-L1 blockade

How does this drug work?

  • Target: PD-L1

Imfinzi is an antibody that attaches to a molecule called PD-L1, which is sometimes present on the surface of cancer cells or other cells within a tumor mass. PD-L1 interacts with a molecule called PD-1, which is present on the surface of T cells – the primary immune cells involved in killing cancer cells. In healthy tissues, the interaction between PD-L1 and PD-1 puts on a brake that keeps T cells from creating an immune reaction that gets out of control. However, cancers can hijack this safety mechanism and prevent T cells from doing their job – killing the cancer cells. When PD-L1 interacts with PD-1 on T cells, the T cells become inactive and do not attack the cancer cells. Imfinzi binds to the PD-L1 molecules on cancer cells and other cells within a tumor mass in such a way that it blocks the interaction between PD-1 and PD-L1, and allows the T cells to be active and attack the cancer cells.

Mechanism of action of Imfinzi


How is this drug given to the patient?

Imfinzi is administered via a tube into a vein (intravenous infusion, or I.V.) over 60 minutes every two weeks, and does not require a hospital stay. For patients with non-small cell lung cancer, the maximum treatment duration is 12 months.


What are the observed clinical results?

It is important to keep in mind that each patient’s actual outcome is individual and may be different from the results found in the clinical studies. In addition, with immunotherapy, sometimes it takes several months for responses to be observed.

Advanced bladder and urinary tract (urothelial cell) cancer

In a clinical trial, 182 patients with advanced bladder and urinary tract cancer that had grown or spread and who had been treated with chemotherapy containing platinum, but it did not work or stopped working, were treated with Imfinzi. At a median follow-up of 6 months, 31 patients (17%) responded to treatment, including 5 patients (3%) whose tumors completely disappeared, and 26 patients (14%) whose tumors partially shrank. Of the 31 responding patients, 45% continued to respond for 6 months or longer, and 16% continued to respond for 12 months or longer. Twenty-five of the 31 responding patients had tumors that tested positive for high levels of the PD-L1 molecule.

Advanced non-small cell lung cancer

In a clinical trial, 713 patients with non-small cell lung cancer that had not spread outside the chest (Stage III), could not be removed by surgery, and who had been treated with and did not progress on at least two cycles of concurrent chemotherapy containing platinum and radiation therapy, were treated with either Imfinzi or placebo. At 33 months after the start of the trial, half of the patients treated with Imfinzi did not experience worsening of their disease for 17 months, compared to 6 months for patients treated with placebo. At 46 months after the start of the trial, 62% of patients treated with Imfinzi were alive, compared with 51% of patients treated with placebo.


What are the side effects?

The most common side effects of Imfinzi include fatigue, muscle and bone pain, cough, inflammation in the lungs, upper respiratory tract infections, shortness of breath, constipation, decreased appetite, nausea, swelling of the arms and legs, urinary tract infection, and rash.

Imfinzi can cause the patient’s T cells to attack healthy cells throughout the body. Because of this, Imfinzi can cause side effects that can become serious or life-threatening, and may lead to death. Some of the serious side effects related to Imfinzi include inflammation of the lungs, liver, or colon. Additionally, problems can arise with the kidneys (including kidney failure), vision, and hormone glands (including thyroid, pituitary, and adrenal glands, as well as the pancreas). Skin problems, severe infections, and reactions related to the infusion may also occur. Patients should report any symptoms to their healthcare provider, who can then initiate actions to limit or reverse the side effects.

For a more complete list of possible side effects, see the full prescribing information.


Additional information

Manufacturer

AstraZeneca

Approval

FDA and EMA


Understanding Cancer Immunotherapy Research

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