KEY TAKEAWAYS
- The CheckMate 67T phase 3 trial aimed to investigate the noninferiority of NIVO SC vs IV and ORR in locally advanced or metastatic ccRCC patients.
- Researchers noticed that NIVO SC demonstrated non-inferior PK and a consistent safety profile with NIVO IV.
Intravenous nivolumab (NIVO IV) has improved outcomes in various tumor types, necessitating administration options to alleviate the treatment burden. SC antibody delivery has proven safe and effective. CheckMate 67T assessed subcutaneous nivolumab (NIVO SC) vs IV in metastatic clear cell renal cell carcinoma (ccRCC).
Saby George and his team aimed to ascertain noninferiority in pharmacokinetics (PK) and objective response rate (ORR), observing a consistent safety profile in locally advanced or metastatic ccRCC.
Researchers performed an inclusive analysis enrolling patients with measurable disease, progression post 1–2 prior systemic regimens, no prior immuno-oncology treatment, and a Karnofsky performance score ≥ 70. Randomized 1:1, patients received NIVO SC 1200 mg + recombinant human hyaluronidase PH20 Q4W or NIVO IV 3 mg/kg Q2W until progression, unacceptable toxicity, withdrawal, completion of 2 years’ treatment, or death. Co-primary PK for noninferiority testing was time-averaged serum concentration over the first 28 days (Cavgd28) and minimum serum concentration at steady state (Cminss), determined through population PK analysis. Key secondary endpoint ORR by BICR was tested for noninferiority, with additional objectives covering PK exposure, safety, efficacy, and immunogenicity.
About 495 patients participated in the study, with (n = 248) receiving NIVO SC and (n = 247) receiving NIVO IV. Median ages were 64 and 66 years for the SC and IV arms, respectively, with a predominance of male participants. The average injection time for NIVO SC was < 5 minutes. Noninferiority was observed for both co-primary pharmacokinetic (PK) endpoints and the key-powered secondary ORR. Local injection-site reactions with NIVO SC occurred in 8.1% of cases, predominantly low-grade and transient. Most deaths resulted from disease progression, while study drug toxicity led to 3/1 deaths with NIVO SC/IV.
The study concluded that the co-primary PK and key-powered secondary objective of ORR endpoints were met, affirming the viability of NIVO SC as a new option to enhance healthcare efficiency. Furthermore, the safety profile of NIVO SC demonstrated consistency with NIVO IV.
The study is sponsored by Bristol-Myers Squibb
Source: https://meetings.asco.org/abstracts-presentations/229894
Clinical Trial: https://clinicaltrials.gov/study/NCT04810078
George S, Bourlon M T, Chacon M R, et al. (2024). “Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T.” Presented at ASCO-GU 2024 (Abstract LBA360).
