Immuno-Oncology Resource Center

Immuno-Oncology Resource Center


Press Release

April 08, 2021
1 min read

Adjuvant pembrolizumab extends DFS in renal cell carcinoma


Press Release

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Adjuvant pembrolizumab prolonged DFS compared with placebo for patients with renal cell carcinoma who underwent nephrectomy with or without resection of metastatic lesions, according to the agent’s manufacturer.

Pembrolizumab (Keytruda, Merck) is an anti-PD-1 therapy.

The randomized phase 3 KEYNOTE-564 trial included 950 patients with renal cell carcinoma who underwent nephrectomy and had intermate-high risk or high-risk disease, or M1 no evidence of disease renal cell carcinoma with clear cell component.

Researchers assigned patients to 200 mg pembrolizumab via IV or placebo on day 1 of each 3-week cycle for up to 17 cycles.

DFS served as the primary endpoint. Secondary endpoints included OS and safety.

An interim analysis conducted by an independent data monitoring committee showed a statistically significant DFS improvement among pembrolizumab-treated patients, according to a Merck-issued press release.

The trial will continue until OS results are available.

Pembrolizumab exhibited a safety profile consistent with that observed in prior studies.

Complete results of KEYNOTE-564 will be presented at a medical meeting, according to the release.

Pembrolizumab is approved in the United States for use in combination with axitinib (Inlyta, Pfizer) for first-line treatment of patients with advanced renal cell carcinoma.

“Since its first approval in renal cell carcinoma nearly 2 years ago, Keytruda has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” Roy Baynes, MD, PhD, chief medical officer, senior vice president and head of global clinical development for Merck Research Laboratories, said in the release. “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. We look forward to sharing results of KEYNOTE-564 with the medical community and regulatory authorities as soon as possible.”