By Fineline Cube 
Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another indication approval from the US Food and Drug Administration (FDA) for its immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab). The therapy is now approved for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC), the most common form of primary liver cancer. This approval expands the therapeutic options for patients with this aggressive disease.
Clinical Trial Evidence
The FDA’s decision is supported by results from the CheckMate-9DW study, a global Phase III randomized, open-label trial comparing the Opdivo-Yervoy regimen to investigator’s choice of tyrosine kinase inhibitor monotherapy (lenvatinib or sorafenib) in patients with previously untreated unresectable or metastatic HCC. The study demonstrated statistically significant improvements in overall survival (OS) and overall response rate (ORR) for the Opdivo-Yervoy combination compared to the comparator arm. Notably, this is the only trial supporting an FDA approval to show superior results against this comparator arm.
Market Impact and Future Outlook
The approval of the Opdivo-Yervoy combination for HCC underscores BMS’s leadership in immuno-oncology and positions the therapy as a new standard of care for patients with unresectable or metastatic liver cancer. This milestone further strengthens BMS’s portfolio of innovative cancer treatments, offering hope for improved outcomes in a disease with limited therapeutic options.-Fineline Info & Tech