Introduction

Dacomitinib (trade name: Vizimpro) has been approved in Germany since April 2019 for the treatment of locally advanced or metastatic non small-cell lung cancer. The drug can be used in adults who have cancer cells with particular mutations that lead to faster tumor growth.

Lung cancer is caused by the malignant growth of cells in the airways (bronchi). It is also referred to as a bronchogenic carcinoma. There are two main types of lung cancer:

  • Small-cell lung cancer (SCLC)
  • Non-small-cell lung cancer (NSCLC)

NSCLC is surgically removed. But sometimes the tumor has already become too large or the cancer has spread to other parts of the body (metastasis) through the blood or lymphatic system. It is then called advanced lung cancer. At that point, a full recovery is often no longer possible. Treatment then aims to stop the cancer from getting worse for as long as possible and reduce the symptoms.

Some people with non-small-cell lung cancer have an abnormal protein in the tumor tissue, called epidermal growth factor receptor (EGFR). The mutated receptor may lead to uncontrolled growth of the tumor. There are a number of different mutations, such as L858R or del19. Dacomitinib aims to block the mutated receptor in these patients, thereby preventing further tumor growth.

Application

Dacomitinib is available in the form of tablets, in three different doses: 15, 30, and 45 mg. The recommended dose is 45 mg once a day, to be taken at the same time every day. If there are side effects, the dose may be adjusted. The treatment is stopped if very severe side effects arise or if the cancer progresses.

Other treatments

For patients with locally advanced or metastatic non-small-cell lung cancer with EGFR mutations L858R or del19, the drugs afatinib, gefitinib or erlotinib are treatment options.

For patients with different EGFR mutations, individually tailored treatment is an option. This treatment is individually modified by the doctor. The medication options then include afatinib, cisplatin or carboplatin.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of dacomitinib compared with the standard treatments for advanced lung cancer with EGFR mutations.

The manufacturer provided one study involving 452 people whose tumor had a L858R or del19 mutation of the EGFR gene. One half of the participants in this study received dacomitinib, and the other half received gefitinib. At the beginning of the study, all participants were in good general health. They were monitored for an average (median) period of a little over 2 years. The following results were found for these patients with L858R or del19 mutations of the EGFR gene:

What are the advantages of dacomitinib?

Life expectancy: The study suggests that dacomitinib has an advantage here. The average (median) time period before people passed away was about 2 years and 10 months in the dacomitinib group, and 2 years and 3 months in the gefitinib group.

Back pain: The study suggests that dacomitinib has an advantage here. This side effect occurred in only 8 out of 100 people who received dacomitinib, but in almost 17 out of 100 people who received gefitinib.

Liver damage: The study suggests that dacomitinib has an advantage here too: For instance, liver enzyme abnormalities were less common in the dacomitinib group than in the gefitinib group.

What are the disadvantages of dacomitinib?

Serious side effects: The study suggests that dacomitinib has a disadvantage here: 24 out of 100 people who used dacomitinib had serious side effects, compared to only 6 out of 100 people who used gefitinib. Serious side effects included severe diarrhea, severe nail infections and severe skin conditions.

Symptoms: The results also suggest that dacomitinib has a disadvantage in terms of symptoms such as diarrhea, loss of appetite, mouth sores, trouble swallowing, disorders of the nervous system and hair loss.

Health-related quality of life: The study suggests that dacomitinib has a disadvantage here too compared with gefitinib. The participants who received dacomitinib

  • felt more restricted in their everyday life, during their free time or at work (role functioning),
  • had more trouble concentrating and remembering things (cognitive functioning),
  • felt more limited in their family life and social activities (social functioning)
  • and generally perceived their health and quality of life (global health status) to be worse than patients who used gefitinib did.

No difference was found in terms of other aspects of health-related quality of life, such as everyday physical activities like grocery shopping or hygiene (physical functioning) as well as irritability or feeling down (emotional functioning).

Side effects: Almost all participants experienced side effects. The study suggests that dacomitinib has a disadvantage here too compared with gefitinib. The following side effects were more common in patients who used dacomitinib:

  • Inflammation of the mucous membranes lining the mouth
  • Dry skin
  • Conjunctivitis (pink eye) and eye diseases

No difference

There was no difference between the treatments in terms of the following aspects:

  • Exhaustion
  • Nausea, vomiting and constipation
  • Breathing problems
  • Sleep problems
  • Coughing and coughing up blood
  • Pain in the chest, arms and shoulders
  • General health
  • Treatment stopped due to side effects

There was also no relevant difference in terms of pain, rib pain, respiratory diseases as well as metabolism and nutrition disorders.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of dacomitinib (Vizimpro).