Pembrolizumab (Keytruda) for the first-line treatment of advanced renal cell cancer with a favorable or intermediate prognosis

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of pembrolizumab in combination with axitinib compared to the standard treatments for advanced renal cell carcinoma with a favorable or intermediate in adults who have not yet had any treatment.

The manufacturer provided one study for this assessment. It was possible to analyze the data of 753 patients from this study. 376 of them were given pembrolizumab and axitinib, and 377 received sunitinib.

This is what was found:

What are the advantages of pembrolizumab?

Life expectancy: The study suggests that pembrolizumab in combination with axitinib can increase life expectancy. About 15 out of 100 people who had treatment with pembrolizumab plus axitinib passed away within 16 months, compared to about 24 out of 100 people who were given sunitinib within the same period.

Severe diseases of the blood and lymphatic system: The study suggests that pembrolizumab in combination with axitinib has an advantage over sunitinib regarding these severe side effects.

Severe infections: Early results suggest that the combination of pembrolizumab and axitinib also has an advantage in terms of this severe side effect.

What are the disadvantages of pembrolizumab?

Treatment stopped due to side effects: Early results suggest that treatment with pembrolizumab in combination with axitinib is stopped due to side effects more often than the treatment with sunitinib is.

Early results suggest that the combination of pembrolizumab and axitinib has a disadvantage regarding the following severe side effects: severe diseases of the liver and gallbladder and severe kidney diseases. These severe side effects were more common in people who had the combination treatment than they were in the sunitinib group.

The study also suggests that pembrolizumab in combination with axitinib has a disadvantage in terms of severe immune-mediated side effects. Immune-mediated side effects are medical conditions in which a person's attacks their own body.

Further side effects for which the study suggests that the combination treatment has a disadvantage include respiratory diseases and hormonal (endocrine) diseases.

No difference

Severe side effects overall: As described above, there were advantages and disadvantages in terms of individual severe side effects. Overall, there was no difference. In each treatment group, severe side effects occurred on average (median value) after two to three months.

What remains unanswered?

The manufacturer didn’t provide any data on the symptoms of the illness, overall health or health-related quality of life.

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Pembrolizumab (combination with axitinib, renal cell carcinoma)  – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-99. February 27, 2020. (IQWiG reports; Volume 887).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on April 23, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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