Keytruda shows significant and meaningfully improvement in kidney cancer

Merck, known as MSD outside the United States and Canada, yesterday announced results from its pivotal phase 3 KEYNOTE-564 trial evaluating Keytruda, its anti-PD-1 therapy.

The trial met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following the surgical removal of a kidney or following nephrectomy and resection of metastatic lesions.

The interim analysis was conducted by an independent Data Monitoring Committee, and Keytruda showed significant and meaningfully improvement compared with placebo in DFS.

Merck’s press release stated: ‘The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies.’

The press release added that results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories said: “Since its first approval in renal cell carcinoma nearly two years ago, Keytruda has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma.

“This new data is 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. We look forward to sharing results of KEYNOTE-564 with the medical community and regulatory authorities as soon as possible.”

Keytruda is currently approved in the US, Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma.