BMS Announces First Phase III Data for Subcutaneous Nivolumab in Advanced ccRCC

On January 27, Bristol-Myers Squibb (BMS) disclosed for the first time the Phase III CheckMate-67T study data on subcutaneous injection of PD-1 nivolumab (Opdivo) for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). This is also the first Phase III clinical trial result of BMS's subcutaneous injection formulation of nivolumab to be announced.

Compared with intravenous infusion of nivolumab, subcutaneous injection of nivolumab demonstrated non-inferiority in the average serum concentration over 28 days (Cavgd28) and the steady-state serum trough concentration (Cminss), achieving the co-primary endpoints. The key secondary endpoint, objective response rate (ORR), also showed non-inferiority.

CheckMate-67T is a randomized, open-label Phase III clinical study (N=495) designed to evaluate the efficacy of subcutaneous injection and intravenous infusion of nivolumab in patients with ccRCC who have previously received systemic therapy.

The results showed that, compared with intravenous infusion (N=247), the Cavgd28 and Cminss of subcutaneous injection of Nivolumab both demonstrated non-inferiority, with geometric mean ratios of 2.098 (90% CI: 2.001-2.200) and 1.774 (90% CI: 1.633-1.927), respectively.

In terms of the key secondary endpoints assessed by BICR, the ORR for patients in the subcutaneous nivolumab group was 24.2%, compared to 18.2% in the intravenous infusion group (RR=1.33; 95% CI: 0.94-1.87), demonstrating non-inferiority; the PFS for patients in the subcutaneous nivolumab group was 7.23 months, while it was 5.65 months for the latter.

In terms of safety, subcutaneous injection of nivolumab is consistent with intravenous infusion. The incidence of local injection site reactions with subcutaneous nivolumab was 8.1%, all of which were low-grade and transient. Additionally, for the subcutaneous and intravenous formulations, the proportions of patients experiencing grade 3-4 adverse events (AEs) were 35.2% and 40.8%, respectively. The incidence rates of treatment-related AEs were 9.7% and 14.7%, serious AEs were 21.1% and 22.9%, and treatment-related serious AEs were both 6.5%.

It is reported that the subcutaneous injection formulation of Nivolumab can complete a single injection in 5 minutes, offering extremely high convenience.

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