Kidney Cancer Coverage from Every Angle
Advertisement
Advertisement

Pembrolizumab Approved by FDA for Adjuvant Treatment of Renal Cell Carcinoma

By: JNCCN 360 Staff
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.



By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.