Imfinzi

Imfinzi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer. It is given by infusion (drip) into a vein.

The dose of Imfinzi and how often it is given depends on the type of cancer being treated. Treatment can continue for as long as the patient benefits from it or for up to 1 year for locally advanced NSCLC.

Treatment may be paused or stopped permanently if the patient gets severe side effects.

For more information about using Imfinzi, see the package leaflet or contact your doctor or pharmacist.

The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to attach to a protein called PD-L1, which is present on the surface of many cancer cells.

PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. By attaching to PD-L1 and blocking its effects, Imfinzi increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.

Non-small cell lung cancer

In one main study of 713 patients with locally advanced non-small cell lung cancer, patients given Imfinzi lived on average for around 17 months without their disease getting worse, compared with 6 months for those given placebo (a dummy treatment). Preliminary results also indicated that patients given Imfinzi lived longer overall compared with patients on placebo.

In another main study of patients with metastatic NSCLC, 338 patients given Imfinzi in combination with tremelimumab and chemotherapy lived on average for 14 months, compared with 12 months for 337 patients given only chemotherapy. They also lived longer without their disease getting worse: around 6 months on average, compared with 5 months for patients who only received chemotherapy.

Small cell lung cancer

In another main study of 805 patients with extensive-stage small cell lung cancer, patients given Imfinzi together with chemotherapy lived on average for 13 months compared with 10 months for those given chemotherapy alone.

Biliary tract cancer

In a study with 685 patients with advanced biliary tract cancer, patients who received Imfinzi plus gemcitabine and cisplatin lived on average for 12.8 months, compared with 11.5 for those who received placebo plus gemcitabine and cisplatin.

Hepatocellular carcinoma

In a main study in patients with advanced hepatocellular cancer who had not been treated before, Imfinzi in combination with tremelimumab increased the time patients lived overall compared with standard treatment (sorafenib): patients who received Imfinzi plus tremelimumab (393 patients) lived on average 16.4 months compared with 13.8 months for those who received sorafenib (389 patients). In about 20% of patients who received this regimen, the tumour shrank or disappeared, and this response lasted about 22 months on average. About 5% of patients who received sorafenib had a response to treatment and their response lasted on average 18 months.

When Imfinzi is given alone, the most common side effects (which may affect more than 1 in 10 people) are cough, nose and throat infections, fever, diarrhoea, abdominal (belly) pain, rash, itching and hypothyroidism (an underactive thyroid gland).

When Imfinzi is given together with chemotherapy, the most common side effects (which may affect more than 1 in 10 people) are leucopenia (low levels of white blood cells, including neutrophils which fight infections), anaemia (low levels of red blood cells), nausea (feeling sick), tiredness, thrombocytopenia (low levels of platelets in the blood), constipation, decreased appetite, abdominal pain, hair loss, vomiting, diarrhoea, fever, rash, itching, increased level of liver enzymes and cough.

When Imfinzi is given with tremelimumab and chemotherapy for non-small cell lung cancer, the most common side effects (which may affect more than 2 in 10 people) are anaemia, nausea, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), tiredness, rash, thrombocytopenia and diarrhoea. The most common serious side effects (which may affect more than 1 in 5 people) are neutropenia and anaemia. Other serious side effects (which may affect up to 1 in 10 people) are pneumonia (infection of the lungs), thrombocytopenia, leucopenia, tiredness, neutropenia with fever, colitis (inflammation of the large intestine) and increased levels of liver enzymes and lipase (an enzyme that helps digest fat, mainly made in the pancreas).

When Imfinzi is given with tremelimumab for hepatocellular cancer, the most common side effects (which may affect more than 1 in 10 people) are peripheral oedema (swelling especially of the ankles and feet) and increased level of lipase.

For the full list of side effects and restrictions of Imfinzi, see the package leaflet.

Imfinzi was shown to increase the time patients with locally advanced non-small cell lung cancer lived without their disease getting worse and the time patients with extensive small cell lung cancer or with biliary tract cancer lived overall. In combination with tremelimumab, Imfinzi had beneficial effects in patients with NSCLC and in those with hepatocellular carcinoma. The use of Imfinzi in patients with locally advanced NSCLC is restricted to those whose cancer produces PD-L1, since a clear benefit was only shown in this group of patients. Side effects with Imfinzi were considered manageable, and its safety profile acceptable and in line with that of similar medicines.

The European Medicines Agency therefore decided that Imfinzi’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imfinzi have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Imfinzi are continuously monitored. Side effects reported with Imfinzi are carefully evaluated and any necessary action taken to protect patients.

Imfinzi received a marketing authorisation valid throughout the EU on 21 September 2018.