Equivalency of SubQ vs IV Nivolumab and Data From CheckMate-67T Breakdown
Panelists discuss how the CheckMate-67T trial established noninferiority of subcutaneous nivolumab to intravenous (IV) nivolumab through pharmacokinetic end points, comparable efficacy (24% vs 18% overall response rate [ORR]), similar safety profiles with mostly mild injection site reactions, and FDA approval across all monotherapy indications.
Equivalency Data and CheckMate-67T Trial Results
Establishing equivalency between subcutaneous and IV formulations requires rigorous evaluation across multiple domains. Regulatory approval studies focus on demonstrating comparable pharmacokinetics, including serum drug concentrations, drug exposure (area under the curve), efficacy outcomes, and safety profiles. Immunogenicity assessments ensure no increased antibody formation with subcutaneous administration. Additionally, these trials incorporate patient-reported outcomes measuring quality of life, treatment tolerability, and injection site reactions, providing comprehensive data to support clinical adoption and address patient concerns about whether subcutaneous formulations are as good as traditional IV therapy.
The CheckMate-67T trial findings established noninferiority of subcutaneous nivolumab, leading to FDA approval in December 2024. This phase 3, multicenter, randomized, open-label study enrolled patients with advanced or metastatic clear cell renal cell carcinoma who had received no more than 2 prior systemic therapies. Patients were randomly assigned 1:1 to receive either subcutaneous nivolumab 1200 mg with hyaluronidase (20,000 U) every 4 weeks, administered over 5 minutes into abdominal subcutaneous tissue, or IV nivolumab 3 mg/kg every 2 weeks, infused over 30 minutes. Primary end points assessed pharmacokinetic exposure comparing subcutaneous vs intravenous routes, whereas secondary end points evaluated ORR, progression-free survival, and overall survival.
