FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma
On November 17, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Efficacy was evaluated in KEYNOTE-564 (NCT03142334), a multicenter, randomized (1:1), double-blind, placebo-controlled trial in 994 patients with intermediate-high or high risk of recurrence of RCC, or M1 no evidence of disease. Patients were randomized to pembrolizumab 200 mg intravenously every 3 weeks or placebo for up to 1 year until disease recurrence or unacceptable toxicity.
The major efficacy outcome measure was investigator-assessed disease-free survival (DFS), defined as time to recurrence, metastasis, or death. An additional outcome measure was overall survival (OS). A statistically significant improvement in DFS was demonstrated at a prespecified interim analysis, with 109 (22%) events in the pembrolizumab arm and 151 (30%) events in those receiving placebo (HR 0.68; 95% CI: 0.53, 0.87; p=0.0010). Median DFS was not reached in either arm. At the time of the DFS analysis, OS data were not mature, with 5% deaths in the overall population.
The most common adverse reactions (≥20%) occurring in patients on this trial were musculoskeletal pain, fatigue, rash, diarrhea, pruritus, and hypothyroidism.
The recommended pembrolizumab dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 12 months. View full prescribing information for Keytruda.
November 19, 2021
https://www.fda.gov/
