BMS, Halozyme score with subcutaneous version of Opdivo

Months after ditching an auto-injected version of Opdivo (nivolumab), Bristol Myers Squibb has found success with a more traditional way to administer its oncology blockbuster—with a syringe and vial.

The phase 3 CheckMate-67T trial measuring subcutaneous nivolumab against the standard intravenous version of the immunotherapy for advanced or metastatic clear cell renal cell carcinoma (ccRCC) has met its co-primary endpoints.

Compared to intravenous Opdivo, the subcutaneous formulation demonstrated noninferiority on two pharmacokinetics markers, meeting its two primary goals. It also matched up on objective response rate (ORR) as a secondary endpoint, demonstrating activity against advanced or metastatic ccRCC in patients who have received prior systemic therapy.

BMS will discuss with regulators the next steps in submitting for the approval of subcutaneous nivolumab “across multiple indications,” the company said.

To create the subcutaneous formulation of Opdivo, BMS teamed up with Halozyme Therapeutics, using its Enhanze drug delivery technology.

Success in CheckMate-67T came after BMS discontinued a portion of the study, terminating its testing of a more convenient auto-injected version of Opdivo.

“We didn't see more additional benefit of continuing that program,” Samit Hirawat, the company’s chief medical officer, said during BMS’s first quarter earnings call.

A subcutaneous version of Opdivo can be administered in less than five minutes, BMS said, as opposed to the 30 to 60 minutes it takes to deliver the drug by IV.

“There remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems,” Gina Fusaro, Ph.D., VP, global program lead, said in a release.

Providing a subcutaneous version of Opdivo could allow BMS to extend the PD-1 inhibitor's patent protection for years beyond its 2028 expiration date. In 2022, BMS recorded $8.25 billion in sales of Opdivo, which was a 10% increase from the previous year.

Other drugmakers are also working to create more convenient delivery options for their PD-1/L1 treatments. Also using Halozyme’s technology, Roche was set up for a September FDA approval of its subcutaneous version of blockbuster Tecentriq but it has been delayed by a manufacturing issue.

Merck also has developed a subcutaneous formulation of Keytruda, hoping to beat the clock for its 2028 loss of exclusivity for its cancer juggernaut.

This has been a successful month for Opdivo. Six days ago, the FDA signed off on the drug as a treatment for earlier-stage melanoma.