The following is a summary of “Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma,” published in the April 2024 issue of Nephrology by Choueiri et al.
Pembrolizumab was approved for renal-cell carcinoma after surgery due to better disease-free survival in the KEYNOTE-564 trial. Uncertainty remained about whether it would also improve overall survival.
Researchers conducted a retrospective study analyzing if pembrolizumab improves overall survival in the third interim analysis of the trial.
They used pembrolizumab (200 mg dose) or placebo in patients with renal-cell carcinoma who had a risk of post-surgery. Medications were given every 3 weeks up to 17 cycles or until recurrence, unacceptable side effects, or withdrawal. Disease-free survival with pembrolizumab was the previous primary endpoint, whereas overall survival was the key endpoint of this trial, with safety as the secondary endpoint.
The results showed that 496 participants received pembrolizumab and 498 got placebo. Till September 15, 2023, the median follow-up was 57.2 months. Pembrolizumab improved disease-free survival as in the previous trial (HR 0.72; 95% CI, 0.59 to 0.87). Pembrolizumab also boosted overall survival significantly at 48 months, with 91.2% in the pembrolizumab group, as compared with 86.0% in the placebo group (HR 0.62, 95% CI, 0.44 to 0.87, P=0.005). Serious adverse events were also higher in the pembrolizumab group (20.7% vs. 11.5%), including grade 3 or 4 events (18.6% vs. 1.2%).
Investigators concluded that pembrolizumab improves overall survival in patients with clear-cell renal-cell carcinoma at risk for recurrence after surgery.
Source: nejm.org/doi/full/10.1056/NEJMoa2312695
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