The anti-PD-1 therapy delivered a statistically significant improvement in OS as an adjuvant treatment in RCC patients at a higher risk of recurrence after nephrectomy
Merck’s anti-PD-1 therapy Keytruda has approvals for the treatment of various cancers. (Credit: Merck & Co., Inc.)
Merck said that Keytruda (pembrolizumab) has met the key secondary endpoint of overall survival (OS) in the Phase 3 KEYNOTE-564 trial in renal cell carcinoma (RCC).
The anti-PD-1 therapy is being evaluated as an adjuvant treatment in the late-stage trial featuring patients at intermediate-high or high risk of recurrence after nephrectomy or after undergoing nephrectomy and resection of metastatic lesions.
During a pre-specified interim analysis review carried out by an independent data monitoring committee, Keytruda exhibited a statistically significant and clinically significant enhancement in OS in comparison to the placebo.
The safety profile of the drug remained in line with observations from earlier studies, with no new safety concerns identified.
KEYNOTE-564 recruited 994 patients who were randomly grouped in a 1:1 ratio.
The subjects were treated with either Keytruda 200mg intravenously on Day 1 of each three-week cycle for up to 17 cycles or placebo, which was saline solution IV on Day 1 of each three-week cycle for up to 17 cycles.
Merck Research Laboratories senior vice president and global clinical development late-stage oncology head Marjorie Green said: “As we continue to evaluate the potential of Keytruda in earlier stages of disease across multiple types of cancer, we hope to reduce disease recurrence and ultimately, improve overall survival outcomes.
“These new results from KEYNOTE-564 are notable and mark the first time a therapy has demonstrated a statistically significant survival benefit compared to placebo in patients with RCC at a higher risk of recurrence following surgery, building on the positive disease-free survival findings from this study that led to approvals around the world for this Keytruda-based regimen.”
Based on a prior pre-specified interim analysis with a median follow-up of 23.9 months, Merck previously reported that the KEYNOTE-564 trial met its primary endpoint of disease-free survival (DFS). This was by delivering a 32% reduction in the risk of disease recurrence or mortality compared to the placebo.
The DFS results drove the approvals of Keytruda as an adjuvant therapy for RCC patients in the US, the European Union, Japan, and other countries.