Effectiveness of Pembrolizumab as Adjuvant Treatment for Renal-Cell Carcinoma
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on May 15th, 2024
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There is a limited number of approved adjuvant treatment for post-resection renal-cell carcinoma. In 2021, Pembrolizumab, an antibody that targets the programmed cell death 1 (PD-1) protein, was approved by the US Food and Drug administration after promising interim results. A recent article in the New England Journal of Medicine provides further insights from the final phase of the study evaluating the efficacy of pembrolizumab as an adjuvant treatment for post-resection renal-cell carcinoma.
The phase 3 clinical trial included a total of 994 patients who had been diagnosed with renal-cell carcinoma and had undergone either partial or radical nephrectomy within the past 12 weeks. The median age of the participants was 60 years old, and more than 30% of them are above the age of 65. More than 85% of the study cohort experienced non-metastasis disease (stage M0) with an intermediate-to-high risk of recurrence. The patients were randomly assigned to be treated with either placebo or intravenous injection with 200 mg of pembrolizumab once every 3 weeks for up to 17 doses. After a median follow-up period of 57.2 months, the researchers concluded that the risk of death or disease recurrence is lower by 28% in those who used pembrolizumab. By the 48th month of the follow-up period, the survival rate in the pembrolizumab was 91.2% and 86.0% in the placebo group. However, the rate of moderate and severe adverse events was significantly higher in those who were treated with the PD-1-targeting antibody. Both this elevated risk in side effect and the clinical benefit of pembrolizumab was consistent with previous studies that was used to support the approval by the Food and Drug administration.
The phase 3 clinical trial included a total of 994 patients who had been diagnosed with renal-cell carcinoma and had undergone either partial or radical nephrectomy within the past 12 weeks. The median age of the participants was 60 years old, and more than 30% of them are above the age of 65. More than 85% of the study cohort experienced non-metastasis disease (stage M0) with an intermediate-to-high risk of recurrence. The patients were randomly assigned to be treated with either placebo or intravenous injection with 200 mg of pembrolizumab once every 3 weeks for up to 17 doses. After a median follow-up period of 57.2 months, the researchers concluded that the risk of death or disease recurrence is lower by 28% in those who used pembrolizumab. By the 48th month of the follow-up period, the survival rate in the pembrolizumab was 91.2% and 86.0% in the placebo group. However, the rate of moderate and severe adverse events was significantly higher in those who were treated with the PD-1-targeting antibody. Both this elevated risk in side effect and the clinical benefit of pembrolizumab was consistent with previous studies that was used to support the approval by the Food and Drug administration.