Bristol Myers Squibb’s star Opdivo now can lay claim to an earlier melanoma stage with a new approval that “reinforces the company’s legacy” in treating the cancer type, it said.
The FDA blessed the PD-1 inhibitor as a post-surgical adjuvant therapy in completely resected stage 2B or 2C melanoma in patients 12 years of age or older, marking Opdivo’s fifth nod in earlier cancer stages, the company said in a release.
The approval was based on BMS’ phase 3 CheckMate-76K trial. In the study, Opdivo was able to reduce the risk of recurrence, new primary melanoma or death by 58% compared with placebo. The drug showed a recurrence-free survival rate of 89%, compared with placebo's 79%, at one year.
Early-stage melanoma patients “may still face the threat of disease recurrence, despite the benefit of surgery, which can impact outcomes,” BMS' SVP and general manager of U.S. cardiovascular, immunology and oncology, Catherine Owen. said.
Now, patients have a new option which “may help prevent recurrence,” Owen added.
The nod in stages 2B and 2C tumors add to previous approvals in stages 3 and 4, giving Opdivo reign over the larger melanoma circle and setting up more competition for Merck & Co.’s Keytruda. The Merck drug earned the same expansion in December 2021 after a study similarly boasted an improvement in recurrence-free survival.
BMS is relying on such label expansions to weather pressure stemming from the Inflation Reduction Act and major patent losses over the coming years, including Opdivo’s loss of exclusivity by the end of the decade. Last month at its R&D day, the company divulged its plans to score more than 25 label expansions in several disease areas such as immunology, oncology and hematology.
For Opdivo specifically, BMS is looking forward to a potential subcutaneous formulation of the med with a readout likely coming in the “next couple of months,” chief medical officer Samit Hirawat, M.D. said in an interview at the time.