Introduction

The drug nivolumab (trade name: Opdivo) has been approved in Germany since April 2016 for the treatment of advanced renal cell cancer. The drug is an option for adults who have already had treatment.

Renal cell cancer is the most common cancer of the kidneys. It usually goes unnoticed for a long time as symptoms only occur in advanced, larger tumors. These symptoms include pain in the kidney area that can spread into the back, or blood in the urine. By then the renal cell cancer may have spread too far into other organs or be too large to surgically remove.

Nivolumab is used to treat advanced renal cell cancer that can no longer be surgically removed or that has already spread to other parts of the body. The aim of treatment with this drug is to stimulate the immune system to fight the cancer.

Application

Nivolumab is given every two weeks in the form of an infusion (an IV drip), and enters the bloodstream directly through a vein. The infusion takes about 60 minutes. The exact dose is based on individual body weight.

Treatment is stopped if the disease gets worse or very severe side effects arise.

Other treatments

The drug everolimus is the standard treatment for adults who have had previous therapy for advanced renal cell cancer.

Sunitib is the standard treatment for adults with advanced renal cell cancer who have already had treatment with temsirolimus.

Assessment

In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether people with advanced renal cell cancer can benefit from treatment with nivolumab.

The manufacturer provided one study involving 821 people. 410 of them had treatment with nivolumab, and 411 were given everolimus. A study comparing nivolumab with sunitinib was not available. So it is not possible to tell whether nivolumab has any advantages or disadvantages compared with sunitinib. The following results apply only to the comparison of nivolumab and everolimus.

What are the advantages of nivolumab?

  • Life expectancy: The study provided evidence that nivolumab has an advantage compared with the standard treatment for people with a poor MSKCC score. This score is used to predict chances of survival, and is based on a number of blood values, current health status and how long ago the condition was diagnosed. A poor score indicates a low likelihood of survival. Half the participants with a poor MSKCC score who had treatment with everolimus already died within about eight months. Half of the patients who received nivolumab passed away within 15 months. For people with a more favorable MSKCC score there was no difference between the treatments.
  • Symptoms: The study found weak evidence that symptoms like pain, exhaustion, trouble breathing, coughing or fever occur later and are less severe with nivolumab than with everolimus. Within about four months symptoms had increased in half the people who took nivolumab. In people who took everolimus, this was the case within only two months.
  • General health: Here too, the study showed weak evidence of a benefit from nivolumab.
  • Severe side effects: Severe side effects occurred later and were less common for treatment with nivolumab than with everolimus. After about seven months, half of the people who took nivolumab had severe side effects. Half of the people who took everolimus had severe side effects after only four months.
  • Disorders of the blood and lymphatic system: The study suggests an advantage for nivolumab for these severe side effects too.
  • Inflammation of the lung and the mucous membranes: The study provides weak evidence for an advantage of nivolumab over the standard treatment in terms of these side effects.
  • Treatment stopped due to side effects: The study also provided weak evidence that treatment with nivolumab is stopped less often due to severe side effects than treatment with everolimus.

No difference

  • Infections and infestations: There was no evidence of any advantage or disadvantage for these side effects.

What remains unanswered?

  • Health-related quality of life: The manufacturer did not provide any relevant data.
  • Muscle and bone pain: It is difficult to draw conclusions about possible advantages or disadvantages from the study's data on these side effects. The possibility that muscle and bone pain occurs more often with nivolumab than with everolimus cannot be ruled out entirely.

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 these reviews and the hearings received, the G-BA passed a resolution on the added benefit of nivolumab (Opdivo).

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