High-Risk Urothelial Carcinoma: Nivolumab Adjuvant Therapy FDA Approval

FDA Approval Announcement

• September 3, 2021

On August 19, 2021, the FDA approved nivolumab as adjuvant therapy for high-risk recurrence post-resection urothelial carcinoma. This represents the first FDA approval of adjuvant checkpoint inhibitor therapy for urothelial cancer.

CHECKMATE-274 Trial Design

Patient Population: High-risk recurrence urothelial carcinoma within 120 days post-resection (n randomized to 1:1)

Treatment Arms:

• Nivolumab 240 mg every 2 weeks (n=928)
• Placebo (n=928)

Primary Endpoint: Recurrence-free survival (disease-free survival)

Duration: Up to 1 year treatment

Key Efficacy Results

Recurrence-Free Survival (Intent-to-Treat):

• Nivolumab median RFS: 20.8 months
• Placebo median RFS: 10.8 months

PD-L1 Expression ≥1% Subgroup:

• Nivolumab median RFS: Not reached
• Placebo median RFS: 8.4 months

PD-L1 Negative Subgroup:

• Hazard ratio: 0.83 (non-stratified analysis)

Safety Profile

Adverse Events: >20 toxicities reported including rash, fatigue, diarrhea, pruritus, myalgia, urinary tract infection

Dosing and Administration

Recommended Dose: Nivolumab 240 mg every 2 weeks OR 480 mg every 4 weeks as adjuvant therapy

Treatment Duration: Up to 1 year

Data Source

FDA Approval: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma

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