These late-breaking data are being presented during an oral session for the first time today at the 2024
At the third pre-specified interim analysis (median follow-up of 57.2 months [range, 47.974.5 months]), KEYTRUDA as adjuvant therapy significantly improved overall survival (OS), the trial's key secondary endpoint, by 38% (HR=0.62 [95% CI, 0.440.87]; p=0.002) compared to placebo. At 48 months, the estimated OS rate was 91.2% for patients who received KEYTRUDA compared to 86.0% for patients who received placebo. The OS benefit for patients who received KEYTRUDA was observed across key subgroups.
'For patients with renal cell carcinoma, up to 40% may experience recurrence following surgery, at which point there is a significantly lower chance of survival,' said Dr.
'The positive overall survival results from KEYNOTE-564 build upon the disease-free survival data, which supported approvals of KEYTRUDA for this indication worldwide,' said Dr.
As previously reported, at an earlier pre-specified interim analysis with a median follow-up of 24.1 months, KEYNOTE-564 met its primary endpoint of disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; one-sided p=0.001) compared to placebo. At this third interim analysis, the DFS benefit was consistent with these previously reported data, with KEYTRUDA as adjuvant therapy reducing the risk of disease recurrence or death by 28% (HR=0.72 [95% CI, 0.59-0.87]) compared to placebo.
KEYTRUDA is approved for the adjuvant treatment of patients with RCC in the
Study design and additional data from KEYNOTE-564
KEYNOTE-564 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03142334) evaluating KEYTRUDA for the adjuvant treatment of patients with RCC who have undergone nephrectomy and who have disease that is intermediate-high risk, high risk or M1 no evidence of disease (NED). The primary endpoint is DFS as assessed by investigator review, and secondary endpoints include OS and safety. The study enrolled 994 patients who were randomized 1:1 to receive either KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for up to 17 cycles) or placebo (saline solution IV on Day 1 of each three-week cycle for up to 17 cycles).
The OS benefit for patients who received KEYTRUDA was observed across key subgroups, including in patients with M0 disease (HR=0.63 [95% CI, 0.44-0.90]), M1 NED (HR=0.51 [95% CI, 0.15-1.75]), PD-L1 Combined Positive Score (CPS)
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