US Approval for BMS' Opdivo Combo in Liver Cancer

The US Food and Drug Administration (FDA) has recently approved a new combination therapy for adults dealing with a specific type of liver cancer known as unresectable or metastatic hepatocellular carcinoma (HCC). This decision endorses the use of Bristol Myers Squibb's (BMS) Opdivo (nivolumab) in conjunction with Yervoy (ipilimumab) as an initial treatment approach.

This landmark approval arises from the results of the Phase III CheckMate-9DW trial, which was an open-label and randomized study. The trial demonstrated significant improvements in both overall response rate (ORR) and overall survival (OS) when comparing the combination therapy to other existing treatments. Specifically, the study matched this combination against the investigator’s choice of a tyrosine kinase inhibitor monotherapy. Participants in the trial had not previously received systemic therapy for their unresectable or advanced HCC and were treated with either lenvatinib or sorafenib as comparative options.

The main goal of the trial was to measure overall survival, while secondary objectives included evaluating the objective response rate and the time it took for symptoms to worsen. The FDA's recent decision fully approves this therapeutic regimen, allowing its use as a first-line treatment. This decision aligns with the positive results observed in the CheckMate-9DW trial, highlighting its effectiveness and safety.

Wendy Short Bartie, the senior vice-president of oncology commercialization at BMS, expressed enthusiasm about the approval. She emphasized the company's dedication to advancing cancer treatments and providing new solutions for patients. She noted that this approval enhances the legacy of their dual immunotherapy approach, which has benefited many patients over the years. This is the second time within a week that Opdivo plus Yervoy has been approved for use in gastrointestinal cancers, showcasing the significant impact of these therapies.

Previously, in 2020, the combination of Opdivo and Yervoy gained accelerated approval from the FDA based on promising results from the Phase I/II CheckMate-040 trial. At that time, it was recognized as a second-line treatment option for patients with advanced HCC who had already been treated with sorafenib.

In addition to advancing their therapeutic options, Bristol Myers Squibb is expanding its strategic partnerships. In March 2025, the company announced plans to acquire 2seventy bio, a long-term partner specializing in cell therapy, in a deal valued at $286 million. This acquisition aims to bolster their capabilities and continue driving innovation in cancer treatment options.

Overall, the FDA's approval of Opdivo and Yervoy as a first-line treatment for liver cancer represents a significant advancement in the field of oncology. It offers a promising new option for patients who have limited treatment choices, potentially improving outcomes and quality of life for those battling this challenging disease.