FDA Approves Nivolumab as First Adjuvant Treatment for High-Risk Urothelial Carcinoma
Posted: Tuesday, August 24, 2021
On August 19, the U.S. Food and Drug Administration (FDA) approved the PD-1–blocking antibody nivolumab (Opdivo) for adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. Nivolumab is the first FDA approval for adjuvant treatment of patients with high-risk urothelial carcinoma.
The FDA’s decision is based on the multicenter CheckMate 274 trial evaluating nivolumab as an adjuvant treatment in patients within 120 days of radical resection of urothelial carcinoma originating in the bladder or upper urinary tract and who were at high risk of recurrence. Patients were randomly assigned to receive 240 mg of nivolumab or a placebo by intravenous infusion every 2 weeks until recurrence or until unacceptable toxicity for a maximum treatment duration of 1 year.
Results showed a statistically significant improvement in disease-free survival in patients on the nivolumab arm compared with the placebo arm. The median disease-free survival was 20.8 months versus 10.8 months, respectively. The median disease-free survival was not reached for patients with tumors expressing PD-L1 ≥ 1% in the nivolumab arm. Meanwhile, patients with tumors expressing PD-L1 ≥ 1% in the placebo group had a disease-free survival of 8.4 months.
About 58% of patients with PD-L1–negative tumors had an unstratified disease-free hazard ratio estimate of 0.83. The overall survival data remain immature, with current results showing 33% of deaths in the overall population. There were approximately 37 deaths (20 in the nivolumab arm, 17 in the placebo arm) among patients with upper tract urothelial carcinoma.
The recommended nivolumab dosage for adjuvant treatment of urothelial carcinoma is 240 mg every 2 weeks or 480 mg every 4 weeks. For full prescribing information, visit accessdata.fda.gov.