- Subcutaneous nivolumab demonstrates noninferior pharmacokinetics (co-primary endpoints) and objective response rate (key secondary endpoint) compared to intravenous Opdivo (nivolumab)
- In the first ever disclosure for the subcutaneous formulation of Opdivo, the CheckMate -67T Phase 3 trial demonstrates activity in advanced or metastatic clear cell renal cell carcinoma
- Company plans to engage in discussions with health authorities regarding next steps for submission and approval of subcutaneous nivolumab across multiple indications
Reno, Nevada (UroToday.com) -- Bristol Myers Squibb (NYSE: BMY) announced that the Phase 3 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 noninferior 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.
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -67T clinical trial.
About CheckMate -67T
CheckMate -67T is a Phase 3 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.
Source: Bristol Myers Squibb. (2023). Phase 3 CheckMate -67T Trial of Subcutaneous Nivolumab (nivolumab and hyaluronidase) Meets Co-Primary Endpoints in Advanced or Metastatic Clear Cell Renal Cell Carcinoma [Press release]. https://news.bms.com/news/corporate-financial/2023/Phase-3-CheckMate--67T-Trial-of-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase-Meets-Co-Primary-Endpoints-in-Advanced-or-Metastatic-Clear-Cell-Renal-Cell-Carcinoma/default.aspx.