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Merck’s KEYTRUDA Meets Endpoint in RCC

Interim analysis shows KEYTRUDA as adjuvant therapy significantly improved overall survival compared to placebo.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Merck announced results from the Phase 3 KEYNOTE-564 trial evaluating its anti-PD-1 therapy KEYTRUDA, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 
 
At the third pre-specified interim analysis (median follow-up of 57.2 months), KEYTRUDA as adjuvant therapy significantly improved overall survival (OS), the trial’s key secondary endpoint, by 38% 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.
 
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% compared to placebo. The DFS benefit was consistent with previously reported data, with KEYTRUDA as adjuvant therapy reducing the risk of disease recurrence or death by 28% compared to placebo.
 
KEYTRUDA is approved for the adjuvant treatment of patients with RCC in the U.S., European Union, Japan and other countries worldwide based on DFS data from KEYNOTE-564, which were first presented at the 2021 ASCO Annual Meeting. Merck is currently working with health authorities to include these OS data in the full KEYTRUDA prescribing information.

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