Bristol Myers Squibb has announced the acceptance by the U.S. Food and Drug Administration (FDA) of its application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a possible first-line treatment for unresectable hepatocellular carcinoma (HCC). This acceptance is based on promising results from the Phase 3 CheckMate -9DW trial.
The FDA has set a goal date of April 21, 2025, for its decision.
HCC, the most common form of liver cancer, is often diagnosed when surgery is not viable. With an increasing incidence in the United States, the need for new treatment options is critical.
Dana Walker, Bristol Myers Squibb’s vice president for gastrointestinal and genitourinary cancers indicated that the CheckMate -9DW trial demonstrated the superiority of Opdivo plus Yervoy in overall survival compared to current treatments and that they are eager to collaborate with the FDA to potentially offer this combination as a new first-line option for patients.”
The trial significantly improved overall patient survival with the Opdivo plus Yervoy combination versus lenvatinib or sorafenib. This combination has previously been used as a second-line treatment for advanced HCC, but these results suggest its potential for early-stage use.
The safety profile of the combination remained consistent with previously known data, and no new safety concerns emerged.
Bristol Myers Squibb expresses gratitude to the participants and researchers involved in the CheckMate -9DW trial.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
