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Surgery (partial or radical nephrectomy) is the standard of care for large, high-risk kidney cancers that have not spread outside the kidney. The cancer can come back (recurrence) after nephrectomy in some patients. Adjuvant therapy is additional treatment that is taken after surgery to reduce the risk of the cancer from coming back.
The immunotherapy, pembrolizumab, has been approved in several countries as an adjuvant therapy to stop the cancer from coming back in other parts of the body.
In the KEYNOTE-564 clinical trial, pembrolizumab (given by an infusion into a vein) has been shown to improve cancer-free survival after nephrectomy for kidney cancer patients at high-risk of their cancer returning compared to a dummy infusion (placebo).
994 patients were enrolled in the trial, of which most had intermediate or high-risk disease. Patients were followed-up for more than 5 and a half years (70 months).
During this time, the average overall survival time could not be calculated for either group because most patients were still alive. However, people treated with pembrolizumab lived longer overall compared to the placebo group, with a 34% lower risk of dying. After five years, about 88% of people who got pembrolizumab were still alive, compared to about 82% in the placebo group.
The benefits of pembrolizumab were seen across all risk categories of patients (low, intermediate and high-risk). This means the positive effect of pembrolizumab was strong and reliable for nearly everyone in the study. The benefit of staying cancer-free with pembrolizumab lasted for at least five and a half years after treatment began.
In summary, adjuvant pembrolizumab continues to improve cancer-free survival in all patients with high-risk kidney cancer compared with placebo:
- With a minimum of five years of follow-up, adjuvant pembrolizumab continued to improve cancer-free and overall survival compared with placebo in patients with kidney cancer at increased risk of recurrence.
- These survival benefits remained consistent for all patients in the study.
- Pembrolizumab also extended time to recurrence of the cancer compared with placebo.
- No new serious treatment-related side effects have been reported in the study for more than three years.
- Pembrolizumab remains the only adjuvant therapy for kidney cancer to demonstrate an overall survival benefit, reinforcing its role as the standard of care for high-risk patients.
These results further support the use of adjuvant pembrolizumab as a standard treatment for patients with kidney cancer at high-risk of returning after surgery.
However, patients should consider their situation carefully with their doctor and discuss the potential risks and benefits of adjuvant pembrolizumab. Currently there is no test to predict which patients might benefit from treatment or who might suffer serious side effects.
