Pembrolizumab following surgery for clear cell renal cell carcinoma (RCC) may offer a potential new standard of care, according to study findings presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
The phase 3 KEYNOTE-564 trial (ClinicalTrials.gov Identifier: NCT03142334) included 994 patients with intermediate high-risk or high-risk cancer or those who had no evidence of disease after primary tumor and soft tissue metastases were completely resected up to 1 year postnephrectomy. All patients underwent surgery at least 12 weeks prior to trial randomization.
The study investigators found that adjuvant immunotherapy with pembrolizumab was significantly associated with a 32% decreased risk of disease recurrence compared with placebo after a median follow-up duration of 24 months. The 24-month estimated disease-free survival (DFS) rate was 77.3% among the patients treated with pembrolizumab compared with 68.1% for placebo recipients, lead investigator Toni K. Choueiri, MD, of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute in Boston, Massachusetts, reported during an ASCO presscast. The estimated preliminary overall survival rate at 24 months was 96.6% for those who received pembrolizumab and 93.5% for placebo.
Approximately half of patients who undergo surgery for kidney cancer experience disease recurrence, Dr Choueiri said, adding that there is no globally accepted standard adjuvant therapy to prevent recurrence supported by high-level evidence. “Pembrolizumab is a potential new standard of care for patients with renal cell cancer in the adjuvant setting,” Dr Choueiri said.
“Despite surgery, recurrence is common in clear cell renal cell carcinoma, and if it does recur, there are limited curative treatment options,” commented ASCO Chief Medical Officer and Executive Vice President Julie R. Gralow, MD. “The results of the KEYNOTE-564 trial support consideration of pembrolizumab as a potential new standard of care in the adjuvant setting to reduce disease recurrence in certain patients with kidney cancer.”
Disclosure: This research was supported by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Choueiri TK, Tomczak P, Park SH, et al. Pembrolizumab versus placebo as post- nephrectomy adjuvant therapy for patients with renal cell carcinoma: randomized, double-blind, phase III KEYNOTE-564 study. J Clin Oncol. 2021;39:(suppl 15; abstr LBA5) doi:10.1200/JCO.2021.39.15_suppl.LBA5
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