BRIEF—Keytruda now approved as monotherapy for adults with RCC by EC

The European Commission has approved another indication for Merck & Co’s mega-blockbuster anti-PD-1 drug Keytruda (pembrolizumab), this time as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

This approval is based on results from the Phase III KEYNOTE-564 trial, in which Keytruda demonstrated a statistically-significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) after a median follow-up of 23.9 months compared to placebo, in patients at increased risk of recurrence (defined in the clinical trial protocol as intermediate-high or high risk following nephrectomy and those with resected advanced disease).

“Keytruda addresses a critical unmet need for treatment options that help patients reduce their risk of cancer returning following surgery,” said Dr Thomas Powles, professor of genitourinary oncology and director of Barts Cancer Centre at St Bartholomew’s Hospital.

0.“The European Commission’s approval of Keytruda brings certain patients with renal cell carcinoma a long-awaited therapy that has demonstrated a statistically-significant reduction in the risk of disease recurrence or death by almost a third he added,”