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The New England Journal of MedicineOverall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma

Enhancing Survival Outcomes in Renal-Cell Carcinoma with Adjuvant Pembrolizumab Therapy

In the KEYNOTE-564 trial, adjuvant pembrolizumab has shown a marked improvement in overall survival for patients with renal-cell carcinoma following surgery. This phase 3, randomized, double-blind, placebo-controlled study confirms pembrolizumab’s effectiveness over placebo in extending life expectancy without recurrence in a high-risk patient group.

Study Design

  • Trial type: Phase 3, double-blind, placebo-controlled
  • Participants: 994 individuals with clear-cell renal-cell carcinoma, at increased risk of recurrence post-surgery
  • Treatment: Pembrolizumab (200 mg) or placebo administered every 3 weeks for up to 17 cycles (about 1 year)
  • Primary end point: Disease-free survival (previously demonstrated)
  • Secondary end points: Overall survival, safety

Key Findings

  • Overall survival significantly increased with pembrolizumab; hazard ratio for death at 0.62 (95% CI, 0.44 to 0.87; P=0.005)
  • 48-month survival rates: 91.2% in the pembrolizumab group vs. 86.0% in the placebo group
  • Consistent benefit across key subgroups
  • Higher incidence of serious adverse events in the pembrolizumab group (20.7%) compared to placebo (11.5%)
  • No deaths attributed to pembrolizumab therapy

HCN Medical Memo
For physicians treating renal-cell carcinoma, the results from the KEYNOTE-564 trial provide a compelling argument for considering adjuvant pembrolizumab in post-surgical management. The therapy not only enhances survival chances but does so with an acceptable safety profile, underlining its potential as a standard care component for high-risk patients.

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