Phase III CheckMate -67T trial of subcutaneous nivolumab (nivolumab and hyaluronidase) meets co-primary endpoints in advanced or metastatic clear cell renal cell carcinoma.-BMS
Bristol Myers Squibb announced that the Phase III CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint.
Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo, the study’s co-primary endpoints. Additionally, subcutaneous nivolumab showed a noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo, a key secondary endpoint. The safety profile of subcutaneous nivolumab was consistent with the IV formulation.
“Intravenous Opdivo has helped transform the treatment of several solid tumor types over the past decade, but there remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. “We are delighted that the results of CheckMate -67T demonstrate that subcutaneous nivolumab delivers non-inferior pharmacokinetics, in addition to objective response rate and safety data consistent with IV Opdivo. We believe this new option, given as a single injection administered in less than five minutes, could transform the treatment experience for both patients and physicians.”
The company will complete a full evaluation of the available CheckMate -67T trial data and work with investigators to present the results at an upcoming medical conference. The company also looks forward to discussing next steps for subcutaneous nivolumab with health authorities across multiple indications. Study follow-up is ongoing to assess additional secondary efficacy and safety endpoints.
About CheckMate -67T : CheckMate -67T is a Phase III randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous (IV) Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or IV Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. IV Opdivo. Objective response rate (ORR) is a key secondary endpoint.
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