Pembrolizumab Approved by FDA for Adjuvant Treatment of Renal Cell Carcinoma
Posted: Friday, November 19, 2021
On November 17, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor pembrolizumab (Keytruda) for the adjuvant treatment of patients with renal cell carcinoma who are at intermediate-high or high risk of recurrence after nephrectomy or following nephrectomy and resection of metastatic lesions. The recommended dosage is 200 mg every 3 weeks or 400 mg every 6 weeks until disease recurrence, unacceptable toxicity, or up to 12 months.
The FDA approval is based on the results of the multicenter KEYNOTE-564 clinical trial. The study recruited 994 patients with intermediate-high or high risk of recurrence of renal cell carcinoma or M1 no evidence of disease. Patients were randomly given either 200 mg of pembrolizumab intravenously every 3 weeks or a placebo for up to 1 year until disease recurrence or unacceptable toxicity.
Results from a prespecified interim analysis showed a statistically significant improvement in disease-free survival with 109 (22%) events in patients given pembrolizumab and 151 (30%) in patients given a placebo (P = .0010). The median disease-free survival was not reached in either arm. Although overall survival data were not mature at the time of analysis, the researchers did observe 5% of deaths in the overall population.
The most common adverse events occurring in 20% or more of patients in the KEYNOTE-564 trial included musculoskeletal pain, fatigue, rash, diarrhea, pruritus, and hypothyroidism. For full prescribing information, visit accessdata.fda.gov.