BMS Gets Phase III Victory for Subcutaneous Formulation of Opdivo in Kidney Cancer

Pictured: BMS office in California/iStock, hapabapa

Pictured: BMS office in California/iStock, hapabapa

Bristol Myers Squibb’s experimental two-part formulation to treat advanced or metastatic clear cell renal cell carcinoma, the most common form of kidney cancer in adults, hit its two primary endpoints and a key secondary endpoint in a Phase III study, the company announced Thursday.

The Checkmate-67T trial was investigating whether a subcutaneous formulation of Opdivo (nivolumab), combined with an enzyme that breaks down hyaluronic acid to aid in absorption, would perform comparably to the approved IV formulation. BMS said that the combination of subcutaneous nivolumab and Halozyme’s proprietary recombinant human hyaluronidase demonstrated noninferiority of time-averaged serum concentration and trough serum concentration at steady state—the two primary endpoints of the study—as well as noninferiority of overall response rate, a key secondary endpoint, relative to intravenous nivolumab.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor intended to enhance the body’s immune response to cancer, and its approval in 2014 as an IV treatment marked the first approval of a PD-1 immune checkpoint inhibitor.

Renal cell carcinoma is the most common form of kidney cancer among adults, and clear cell renal carcinoma is the most common form, BMS said, with five-year survival rates for metastatic or advanced kidney cancer as low as 14%.

“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,” Gina Fusaro, vice president and global program lead at BMS, said in a statement. “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.”

BMS will present the results at an upcoming medical conference, as well as discuss the next steps with health authorities across multiple indications, while ongoing follow-up will assess “additional secondary efficacy and safety endpoints.”

The news comes after BMS dropped another alternative to the IV treatment. CMO Samit Hirawat said during a first-quarter earnings call that the company was terminating testing of an auto-injected version, saying BMS “didn’t see more additional benefit of continuing that program.”

Opdivo has been a cash cow for BMS, raking in $8.25 billion in sales in 2022, up 10% over 2021, and the success of a subcutaneous version could enable the company to extend its patent protection for it beyond the 2028 expiration date.

Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.

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