Introduction

The drug durvalumab (trade name: Imfinzi) has been approved in Germany since September 2018 for the treatment of locally advanced lung cancer. It is an option for adults with non-small-cell lung cancer that can no longer be surgically removed, if they have had platinum-based chemotherapy combined with radiotherapy and it was able to prevent further progression of the illness.

Lung cancer is caused by the growth of malignant cells in the airways (bronchi) and their branches (bronchioles). It is also referred to as a bronchial carcinoma. There are two main types of tumors:

  • small-cell lung cancer (SCLC) and
  • non-small-cell lung cancer (NSCLC).

NSCLC is surgically removed, if possible. But sometimes it is already too large or has spread to other parts of the body (metastasis) through the blood or lymphatic system. It is then called advanced lung cancer.

Pembrolizumab has been approved for use in people who have a tumor with elevated levels of the protein PD-L1. This protein weakens the body's immune response to the tumor cells. Durvalumab blocks the effect of PD-L1 in order to prevent further tumor growth.

Application

Durvalumab is given every two weeks through an intravenous drip (infusion) at a dose of 10 mg per kilogram of body weight. Each infusion lasts one hour.

Treatment is stopped if the disease progresses or if very severe side effects arise. But it is stopped after 12 months at the most anyway.

Other treatments

For adults with locally advanced lung cancer and the PD-L1 mutation who have had treatment before and can no longer have surgery, best supportive care (BSC) is an option. This should be tailored to the patient's individual needs, with the aim of relieving symptoms and improving quality of life.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of durvalumab for people with locally advanced lung cancer and a PD-L1 mutation compared with supportive care. The manufacturer provided IQWiG with one ongoing study that provided at least preliminary answers to some questions. Data from 303 patients was analyzed. A total of 212 of them had treatment with durvalumab, while 91 of them were given a placebo (fake medication). Both groups also had BSC. Despite the locally advanced stage of their condition, the patients involved were in good general health. This is what was found:

What are the advantages of durvalumab?

  • Life expectancy: The results suggest that durvalumab has an advantage here. Of the people who were given a placebo, 50 out of 100 passed away within about 29 months. Of those people who had treatment with durvalumab, only 30 out of 100 passed away within the same time.
  • Dizziness: The study suggests that durvalumab has an advantage for men in terms of this side effect. Dizziness was less common in men who received durvalumab. There was no difference for women.

What are the disadvantages of durvalumab?

  • Treatment stopped due to side effects: The study suggests that durvalumab has a disadvantage here: Treatment with durvalumab was most commonly stopped due to a particular form of pneumonia (pneumonitis).
  • Severe immune-mediated side effects: Immune-mediated side effects are medical conditions in which a person's immune system attacks their own body. The study suggests that durvalumab has a disadvantage here too.
  • Severe heart problems: These severe side effects were more common during treatment with durvalumab than with a placebo.
  • The study also suggests that durvalumab has a disadvantage concerning the following side effects:
    • Skin conditions such as rashes or itching
    • Injuries, poisoning, and complications due to treatment, such as pneumonia that was caused by radiotherapy (radiation pneumonitis) instead of bacteria, viruses or fungi.

No differences

  • Health-related quality of life, general health, and severe side effects: There was no noticeable difference between durvalumab and the placebo here.
  • There was also no difference in terms of the following symptoms:
    • Nausea and vomiting
    • Body aches
    • Sleep problems
    • Loss of appetite
    • Constipation and diarrhea
    • Coughing and coughing up blood
    • Hair loss
    • Trouble swallowing
    • Sore mouth
    • Nerve problems

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 durvalumab (Imfinzi).