Keytruda (pembrolizumab) reduced the risk of death by 38% versus placebo as adjuvant therapy for patients with renal cell carcinoma (RCC) at an increased risk of recurrence following nephrectomy
Merck Inc., known as MSD outside of the United States and Canada, announced results from the Phase III KEYNOTE-564 trial evaluating Keytruda Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
These late-breaking data are being presented during an oral session for the first time at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA359) and are included in the official ASCO GU Press Program.
At the third pre-specified interim analysis (median follow-up of 57.2 months [range, 47.9?74.5 months]), Keytruda as adjuvant therapy significantly improved overall survival (OS), the trial’s key secondary endpoint, by 38% (HR=0.62 [95% CI, 0.44?0.87]; 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. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School. “Results from KEYNOTE-564 show that pembrolizumab as adjuvant therapy significantly improved overall survival by 38% compared to placebo, becoming the first ever Phase III adjuvant trial to show improved survival for renal cancer patients at risk of recurrence after surgery.”
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 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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