- An experimental, under-the-skin shot of Bristol Myers Squibb’s immunotherapy Opdivo appeared to work similarly to the approved, intravenous version of the drug, shrinking kidney tumors at an equivalent rate, the company said Saturday.
- The subcutaneous shot also had a similar side effect profile, with about 7% of patients receiving either version experiencing a “serious treatment-related adverse event,” Bristol Myers said. The Phase 3 trial, called CheckMate -67T, is the first to show the new formulation as “noninferior” to the intravenous version that Bristol Myers launched 10 years ago.
- The trial data, disclosed at an American Society of Clinical Oncology meeting, could help Bristol Myers protect Opdivo revenues after the drug’s main patent expires in 2028. Cancer immunotherapy rivals Merck & Co. and Roche have been working on subcutaneous versions of their respective drugs Keytruda and Tecentriq, with Roche potentially launching its shot this year.
Bristol Myers’ 500-person study assessed whether the two versions of Opdivo were processed by the body similarly, as well as compare their efficacy and safety. To succeed, the subcutaneous shot only had to prove noninferior, because Bristol Myers hopes to use it to replace the intravenous form.
Results showed that, with either version, the average and lowest blood concentration levels were similar, meeting the study’s primary goals.
Bristol Myers also measured remission rates and disease progression in participants, who had cancer so far advanced it couldn’t be treated with surgery or radiation, or had spread beyond the kidney. In patients taking the subcutaneous version, treatment shrank or eliminated tumors in 24%, compared with 18% in the group given intravenous Opdivo — a statistically similar rate.
Patients getting the under-the-skin shot went a median of 7.2 months without dying or their disease progressing, compared with 5.4 months in those who got the intravenous formulation. Investigators didn’t, however, design the trial to detect statistical similarity on that measure.
“Having the option to administer immunotherapy subcutaneously could undoubtedly reduce the treatment burden that patients diagnosed with cancer currently face, as well as help maximize efficiencies within healthcare systems,” said Saby George, a professor at the State University of New York Buffalo medical school, in a statement provided by Bristol Myers.
Opdivo is Bristol Myers’ second-biggest drug after blood thinner Eliquis, recording $6.6 billion in sales through the first nine months of 2023. Both face patent expiration later this decade, making conversion of Opdivo to subcutaneous use a major company goal.
In its presentation to the J.P. Morgan Healthcare Conference earlier this month, Bristol Myers executives said they expect to be able to retain 65% to 75% of Opdivo’s U.S. usage through conversion to subcutaneous use and through a combination drug that’s now approved in melanoma.