Merck & Co – known as MSD outside the US and Canada – has shared positive results from a late-stage study of its anti-PD-1 therapy Keytruda (pembrolizumab) in patients with renal cell carcinoma (RCC), the most common type of kidney cancer.
The phase 3 KEYNOTE-564 trial has been evaluating Keytruda as an adjuvant treatment in RCC patients who are at an intermediate-to-high or high risk of recurrence following nephrectomy – the surgical removal of a kidney – or following nephrectomy and resection of metastatic lesions.
RCC accounts for about 90% of all kidney cancer diagnoses and is associated with a high risk of recurrence, with up to 40% of newly diagnosed patients experiencing recurrence within five years after surgery.
According to results from a third pre-specified interim analysis of KEYNOTE-564, which were presented at this year’s American Society of Clinical Oncology Genitourinary Cancers Symposium, Keytruda 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 Keytruda-treated patients compared to 86% for those in the placebo cohort, and the OS benefit for patients who received Keytruda was observed across key subgroups.
As previously reported by Merck, the trial met its primary endpoint of disease-free survival (DFS) at an earlier interim analysis, reducing the risk of disease recurrence or death by 32% compared to placebo. The DFS benefit at the third interim analysis was consistent with this, the company said, with Keytruda reducing the risk of disease recurrence or death by 28% compared to placebo.
Keytruda is already approved for the adjuvant treatment of patients with RCC in the US, EU, Japan and other countries worldwide based on DFS data from KEYNOTE-564, and Merck is currently working with health authorities to include the latest OS data in the full Keytruda prescribing information.
Dr Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said: “The positive overall survival results from KEYNOTE-564 build upon the disease-free survival data, which supported approvals of Keytruda for this indication worldwide.
“This is the second Keytruda study to demonstrate a significant overall survival benefit in an earlier stage of cancer, and these new results add to the progress we’re making in earlier stages of disease.”