Merck & Co. says adjuvant Keytruda hits main goal of late-stage RCC study

Merck & Co. announced Thursday that a Phase III study of Keytruda (pembrolizumab) as adjuvant therapy in patients with renal cell carcinoma (RCC) following surgery achieved its primary endpoint of disease-free survival (DFS). The company noted that results from the KEYNOTE-564 trial will be submitted to regulatory authorities.

The study included 950 patients with RCC who had undergone nephrectomy and who had intermediate-high risk, high risk, or M1 no evidence of disease RCC with clear cell component. Subjects were randomised to receive Keytruda monotherapy or placebo as adjuvant treatment.

According to Merck, based on an interim analysis conducted by an independent data monitoring committee, Keytruda demonstrated a significant and clinically meaningfully improvement in DFS compared with placebo. The drugmaker added that the trial will continue to evaluate the key secondary endpoint of overall survival, while results will also be presented at an upcoming medical meeting.

Roy Baynes, head of global clinical development at Merck Research Laboratories, remarked "these new data are the result of our research to evaluate the role of Keytruda in helping patients with earlier stages of disease and are the first positive results for an anti-PD-1 therapy in the adjuvant treatment of patients with renal cell carcinoma."

Keytruda, which generated sales of $4 billion in the fourth quarter of 2020, is currently approved in the US, Europe and Japan in combination with Pfizer's tyrosine kinase inhibitor Inlyta (axitinib) for the first-line treatment of patients with advanced RCC. Earlier this year, Merck and Eisai announced detailed results from the Phase III CLEAR study, showing that the combination of Keytruda and Lenvima (lenvatinib) significantly reduced the risk of disease progression or death by 61% versus Pfizer's Sutent (sunitinib) for the first-line treatment of patients with advanced RCC.

For related analysis, see ViewPoints: It becomes CLEAR that Keytruda/Lenvima is another potent RCC combo. See also FirstImpact results: Survey says expect strong uptake of Keytruda/Lenvima in RCC…

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