Adjuvant pembrolizumab improves disease-free survival in renal cell carcinoma
Pembrolizumab (Keytruda; Merck) improved disease-free survival (DFS) compared with placebo in patients with renal cell carcinoma (RCC) following nephrectomy or following nephrectomy and resection of metastatic lesions, according to data from the pivotal Phase 3 KEYNOTE-564 trial announced in a company press release.
An interim analysis conducted by an independent Data Monitoring Committee found that pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in DFS compared with placebo. The trial is continuing to evaluate the secondary endpoint of overall survival.
“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,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press 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.”
Read the full press release here.