Tecentriq

Tecentriq is given as an infusion (drip) into a vein every 2, 3 or 4 weeks (depending on the type of cancer), and treatment should continue for as long as the patient benefits from it or does not suffer from unmanageable side effects. Treatment may need to be stopped if the patient has certain side effects caused by their immune system (the body’s defence system) including inflammation of various body organs or endocrine (glandular) disorders. For more information about using Tecentriq, see the package leaflet or contact your doctor or pharmacist.

Tecentriq can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer.

The active substance in Tecentriq, atezolizumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called PD-L1 (programmed death-ligand 1), which is present on many cancer cells.

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

Urothelial cancer

Tecentriq reduces tumours in patients with urothelial cancer that is advanced or has spread. In a study of 429 patients, the cancer shrank or was eliminated after Tecentriq treatment in 23% of patients who were not eligible for platinum chemotherapy and in 16% of patients who had previously had platinum chemotherapy.

In another study involving 931 patients with urothelial cancer, those given Tecentriq lived slightly longer (8.6 months) than patients given chemotherapy (8 months) although the difference could be due to chance. Response was seen even in patients whose cancer cells did not produce much PD-L1.

Lung cancer

In patients with non-small cell lung cancer which is advanced or has spread, Tecentriq is more effective than docetaxel (another cancer medicine) at prolonging patients’ lives. In one main study of 850 patients, those given Tecentriq lived for 14 months on average while those given docetaxel lived for 10 months. In a second study of 287 patients, patients on Tecentriq lived for 13 months on average compared with 10 months for patients on docetaxel.

In another main study of 1,202 patients with advanced non-small cell lung cancer which has spread and who had not had chemotherapy before, patients given Tecentriq together with paclitaxel, carboplatin and bevacizumab lived on average for 8.4 months without their disease getting worse while those given paclitaxel, carboplatin and bevacizumab lived on average for 6.8 months without their disease getting worse. Overall, patients given Tecentriq with the other medicines lived for 19.8 months on average compared with 14.9 months for patients given the medicines without Tecentriq.

Another study investigated the effect of Tecentriq in 679 previously untreated patients with non-smallcell lung cancer (NSCLC) who did not have a type of cancer known as EGFR mutant or ALK-positive NSCLC. Patients lived on average for 18.6 months when they were given Tecentriq with carboplatin plus nab-paclitaxel compared with 13.9 months when given the combination without Tecentriq. In addition, patients lived for about 7 months without their disease getting worse when they received the Tecentriq combination compared with 5.5 months without Tecentriq.

Finally, in a study of 403 patients with the generally more aggressive small cell lung cancer, patients lived for 12.3 months on average when Tecentriq was added to carboplatin plus etoposide, compared with 10.3 months when placebo (a dummy treatment) was added instead. In addition, patients given the Tecentriq combination lived for 5.2 months on average without their disease getting worse compared with 4.3 months for patients who were not given Tecentriq.

Breast cancer

A study of 902 patients with a type of breast cancer known as triple-negative breast cancer looked at the effect of combining Tecentriq with nab-paclitaxel. Patients whose cancer produced the PD-L1 protein up to a certain level lived for an average of 25 months on the Tecentriq plus nab-paclitaxel combination compared with 18 months when given placebo plus nab-paclitaxel. Patients in the Tecentriq group also lived for longer without their disease getting worse (7.5 months versus 5.3).

Hepatocellular carcinoma

A study involved 501 patients with hepatocellular carcinoma that had spread and had not been treated previously. Patients treated with Tecentriq in combination with bevacizumab lived on average for 6.8 months without their disease getting worse, compared to 4.3 months for patients treated with sorafenib.

The most common side effects with Tecentriq when used on its own (which may affect more than 1 in 10 people) are tiredness, reduced appetite, nausea (feeling sick), vomiting, cough, difficulty breathing, diarrhoea, rash, fever, pain in the back, joints, muscles and bones, weakness, itching and urinary tract infection (infection of the structures that carry urine).

The most common side effects with Tecentriq when used with other cancer medicines (which may affect more than 2 in 10 people) are peripheral neuropathy (nerve damage in the hands and feet), nausea, anaemia (low red blood cell counts), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), rash, tiredness, constipation, reduced appetite, diarrhoea, and cough.

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

In urothelial cancer, Tecentriq has been shown to reduce tumour size in patients who have been treated with platinum chemotherapy or who are not eligible for such treatment. Tecentriq can also improve survival in patients with lung cancer, triple-negative breast cancer and hepatocellular carcinoma.

Tecentriq’s side effects when used alone are less troublesome than standard chemotherapy treatments. When Tecentriq is used in combination with other cancer medicines, the side effects are more severe but are considered manageable.

The company that markets Tecentriq is providing an educational program for patients and healthcare professionals to explain that serious immune-related side effects can occur during treatment and what they should do to minimise risks. The company is also carrying out studies to provide more data on the effectiveness of Tecentriq in urothelial cancer and on the medicine’s safety.

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

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

Tecentriq received a marketing authorisation valid throughout the EU on 21 September 2017.