Injectable nivolumab meets endpoints in noninferiority trial for advanced kidney cancer
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A subcutaneous nivolumab formulation showed noninferior pharmacokinetics and objective response rates compared with IV nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma, according to the agent’s manufacturer.
Topline data from the phase 3 CheckMate -67T noninferiority trial suggested an acceptable safety profile for the subcutaneous formulation of nivolumab (Opdivo, Bristol Myers Squibb) — a PD-1 inhibitor — that is comparable with the known toxicity profile of the IV formulation.
The subcutaneous version of nivolumab has been co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, also known as rHuPH20.
“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 health care systems,” Gina Fusaro, PhD, vice president, global program lead for Bristol Myers Squibb, said in a company-issued press release.
“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,” Fusaro added. “We believe this new option — given as a single injection administered in less than 5 minutes — could transform the treatment experience for both patients and physicians.”
The open-label CheckMate -67T trial enrolled 495 patients randomly assigned to receive either subcutaneous or IV nivolumab. Time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. IV nivolumab served as dual primary endpoints for the study, with objective response rate a key secondary endpoint.
Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 and Cminss compared with IV nivolumab. Moreover, the subcutaneous formulation showed a noninferior ORR as assessed by a blinded independent central review committee compared with those who received IV nivolumab.
The manufacturer said it plans to work with investigators to perform a comprehensive analysis of the study data and present the findings at an upcoming major medical meeting.
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