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One year of pembrolizumab after surgery for high-risk kidney cancer reduced relapses by about a third and, in later follow-up, became the first adjuvant treatment to help kidney cancer patients live longer.
Double-blind, placebo-controlled phase 3 trial of 994 patients with clear-cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or with resected metastatic disease (M1 NED), randomised to one year of pembrolizumab or placebo. Primary endpoint was disease-free survival.
24-month DFS was 77.3% vs 68.1% (HR 0.68). The 2024 overall survival analysis showed HR 0.62 with 48-month OS 91.2% vs 86.0%. It was the first adjuvant therapy in kidney cancer to improve survival, after decades of negative trials with cytokines and VEGF inhibitors, and it stands alone: three other adjuvant checkpoint inhibitor trials (IMmotion010, CheckMate 914, PROSPER) were negative.
Patients whose kidney cancer has been removed but who are at high risk of recurrence (large or high-grade tumours, node involvement, or resected metastases) can now be offered a year of pembrolizumab, which increases the chance of being alive and cancer-free several years later. Roughly nine patients need treatment to prevent one recurrence at two years, and some will have permanent side effects, so shared decision-making matters. Why pembrolizumab succeeded where similar drugs failed is not fully understood.
Shares Biomarker-selected adjuvant therapy in RCC (ctDNA, CAIX PET, gene signatures), Toni K. Choueiri, Clear cell renal cell carcinoma, Overall survival (OS).
Shares Make six-weekly immunotherapy the default schedule, Restore weight-based dosing and vial sharing for immunotherapy in the label, A single calibrated tumour mutational burden across all sequencing panels, Immune-related adverse events (irAEs).
Shares Toni K. Choueiri, Clear cell renal cell carcinoma, Overall survival (OS), Merck & Co. (MSD).
Shares Jae Lyun Lee, Clear cell renal cell carcinoma, Merck & Co. (MSD), Renal cell carcinoma.
Shares Biomarker-selected adjuvant therapy in RCC (ctDNA, CAIX PET, gene signatures), Merck & Co. (MSD), Renal cell carcinoma, Pembrolizumab.
Shares Make six-weekly immunotherapy the default schedule, Restore weight-based dosing and vial sharing for immunotherapy in the label, Overall survival (OS), PD-1.
Shares Immune-related adverse events (irAEs), Dormant cells and minimal residual disease, Neoadjuvant / adjuvant / perioperative, Merck & Co. (MSD).
Shares Clear cell renal cell carcinoma, Merck & Co. (MSD), Renal cell carcinoma, Pembrolizumab.