Bristol Myers Squibb announced that a phase 3 trial of a subcutaneous formulation of its blockbuster Opdivo met co-primary endpoints in kidney cancer.
The CheckMate -67T noninferiority trial evaluated the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy.
The trial met its co-primary endpoints, demonstrating that subcutaneous nivolumab delivers noninferior pharmacokinetics in addition to a key secondary endpoint, delivering an objective response rate consistent with IV Opdivo. 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 health care systems,” said Gina Fusaro, VP global program lead, Bristol Myers Squibb.
Opdivo, which was first approved in late 2014 for melanoma, was the first PD-1 immune checkpoint inhibitor to receive regulatory approval. Now one of the top-selling drugs in the world, Opdivo and Opdivo-based combinations have demonstrated mixed effectiveness in treatments for several tumor types, including bladder cancer and melanoma.
The injection formulation of Opdivo used in the CheckMate -67T trial was formulated using Halozyme Therapeutics' primary technology, Enhanze. The technology is based on Halozyme's proprietary recombinant human hyaluronidase PH20 enzyme that degrades hyaluronan. By degrading hyaluronan, rHuPH20 facilitates the dispersion and absorption of other drugs and fluids that are injected under the skin.
It's the same drug delivery system being used in formulations of Herceptin and Rituxan. Earlier this month, Genentech shared data from a phase 3 trial demonstrating that a subcutaneous injection formulation of multiple sclerosis blockbuster Ocrevus performed just as well as the original IV formulation. The IV formulation also uses Halozyme's Enhanze drug delivery technology.