AI Article Synopsis
- The evolving oncology treatment landscape shows a need for better administration options that enhance patient experiences and healthcare efficiency.
- A phase III trial (CheckMate 67T) compared subcutaneous nivolumab to intravenous nivolumab in patients with advanced clear cell renal cell carcinoma, focusing on pharmacokinetics and objective response rates.
- Results indicated that subcutaneous nivolumab was noninferior to the intravenous form, showing similar efficacy and safety profiles, with no new safety concerns emerging.
Article Abstract
Background: The evolving oncology treatment paradigm has created an unmet need for administration options that improve patient experiences and health care efficiencies.
Patients And Methods: CheckMate 67T (NCT04810078) was a phase III, open-label, multicenter, noninferiority trial in which patients with advanced/metastatic clear cell renal cell carcinoma were randomized to subcutaneous nivolumab (1200 mg every 4 weeks; coformulated with recombinant human hyaluronidase PH20 20 000 units) or intravenous nivolumab (3 mg/kg every 2 weeks). The primary objective was to assess the noninferiority of subcutaneous versus intravenous nivolumab by coprimary endpoints determined from a population pharmacokinetics analysis [time-averaged serum concentration over the first 28 days (C), and minimum steady-state serum concentration (C); noninferiority threshold: lower boundary of 90% confidence interval (CI) of the geometric mean ratios (GMR) ≥0.8]. Objective response rate (ORR) was a key secondary endpoint powered for noninferiority [noninferiority threshold: lower boundary of 95% CI of relative risk of ORR (subcutaneous versus intravenous nivolumab) ≥0.60].
Results: Overall, 495 patients were randomized. Relative exposure in the subcutaneous versus intravenous arm reported by the GMR of C and C was 2.098 (90% CI 2.001-2.200) and 1.774 (90% CI 1.633-1.927), respectively. After 8 months of minimum follow-up, ORR was 24.2% with subcutaneous nivolumab (95% CI 19.0%-30.0%) versus 18.2% with intravenous nivolumab [95% CI 13.6%-23.6%; relative risk: 1.33 (95% CI 0.94-1.87)]. Coprimary endpoints and ORR met noninferiority thresholds. Additional efficacy and safety measures were similar.
Conclusions: Subcutaneous nivolumab was noninferior to intravenous nivolumab based on pharmacokinetics and ORR. No new safety signals were observed.
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| http://dx.doi.org/10.1016/j.annonc.2024.09.002 | DOI Listing |
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