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# Positive Data in Keytruda Kidney Cancer Trial
- URL: https://www.fdaweb.com/positive-data-in-keytruda-kidney-cancer-trial/
- Published: 2024-01-29T12:00:00.000Z
- Updated: 2026-09-14T14:21:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156239

Merck says data from its Phase 3 KEYNOTE-564 trial evaluating Keytruda (pembrolizumab) as an adjuvant treatment in patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions showed a promising overall survival (OS) benefit. The company says that this is the third pre-specified interim analysis (median follow-up of 57.2 months) and it showed that Keytruda as an adjuvant therapy significantly improved OS 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,” it says. While OS was a secondary endpoint in the trial, its benefit in patients was observed across key subgroups, it adds.

Merck notes that Keytruda is approved for the adjuvant treatment of patients with RCC in the U.S. based on disease-free survival data from KEYNOTE-564, which were [first presented](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fmercks-keytruda-pembrolizumab-given-after-surgery-reduced-the-risk-of-disease-recurrence-or-death-by-32-versus-placebo-as-adjuvant-therapy-in-patients-with-renal-cell-carcinoma-rcc%2F&esheet=53888345&newsitemid=20240127244606&lan=en-US&anchor=first+presented&index=1&md5=4bc582f78ba1d60deff0f919ae2c025f&ref=fdaweb.com) at the 2021 ASCO annual meeting. The company says it is currently working with health authorities to include the OS data in the full Keytruda prescribing information.