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Adjuvant Immunotherapy for High-Risk Kidney Cancer
Patients with high-risk localized kidney cancer after nephrectomy have a high rate of systemic recurrence. Investigators of the industry-sponsored, randomized 3 KEYNOTE-564 trial previously reported a statistically and clinically significant improvement in disease-free survival in patients with clear-cell renal-cell carcinoma and high-risk pathology managed with 1 year of adjuvant pembrolizumab compared to placebo. At the time of the initial report, at a median follow-up of 24 months, data for overall survival were immature. Now, the investigators report results at a median follow-up of 57 months.
Of nearly 1000 participants, the estimated percentage who were alive at 48 months was 91.2% in the pembrolizumab group and 86.0% in the placebo group. Overall survival was significantly improved with pembrolizumab compared with placebo (hazard ratio for death, 0.62; P=0.005).
Grade 3 or higher adverse events of any cause occurred in 32.0% of pembrolizumab recipients and 17.7% of placebo recipients. No deaths related to pembrolizumab therapy occurred.
Comment
As noted by editorialists, 57% of patients in the placebo group were alive and free from recurrence at 48 months, and using the KEYNOTE-564 trial selection criteria would lead to a significant chance of overtreatment and risk exposure to treatment-related short-term and long-term immune-mediated adverse events in approximately one in two patients. The editorialists also note that less than half of the 210 patients with recurrence in the placebo group had received subsequent anti–PD-1/PD-L1 therapy at the time of the report.
The findings of this trial establish pembrolizumab as a standard of care in patients at high risk for recurrence following nephrectomy. Ongoing translational work aims to improve patient selection for treatment. The optimal therapy for patients whose disease progresses while on adjuvant pembrolizumab or shortly thereafter remains undefined.
Citation(s)
Author:
Choueiri TK et al.
Title:
Overall survival with adjuvant pembrolizumab in renal-cell carcinoma.
Source:
N Engl J Med
2024
Apr
18; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
Robert Dreicer, MD, MS, MACP, FASCO