Bristol Myers Squibb (BMY) has revealed positive outcomes from the Phase 3 CheckMate -9DW clinical trial, showcasing the effectiveness of combining Opdivo (nivolumab) with Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy. This combination treatment demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to traditional treatments of sorafenib or lenvatinib, as assessed at a pre-specified interim analysis.
The trial’s results mark a pivotal advancement in treating advanced HCC, offering new hope to patients with limited treatment options. The safety profile of the Opdivo plus Yervoy combination remained consistent with previously reported outcomes and was deemed manageable with established protocols, with no new safety concerns arising.
Dana Walker, M.D., M.S.C.E., Vice President at Bristol Myers Squibb, emphasized the crucial need for more treatment options to enhance survival rates among patients with advanced-stage liver cancer. The noteworthy survival benefits observed in the CheckMate -9DW trial underscore the potential of the Opdivo plus Yervoy combination to outperform well-established tyrosine kinase inhibitor (TKI) treatment alternatives.
Bristol Myers Squibb plans to comprehensively evaluate the trial data and engage with health authorities and the scientific community to discuss these findings. Further details will be shared at an upcoming medical conference, highlighting the significance of this breakthrough in the treatment of hepatocellular carcinoma.
CheckMate -9DW is a Phase 3, open-label, randomized trial that compares the efficacy of Opdivo plus Yervoy against the investigator’s choice of sorafenib or lenvatinib monotherapy in patients with advanced HCC who have not undergone prior systemic therapy. Approximately 668 patients were randomized to receive either the immunotherapy combination, sorafenib, or lenvatinib oral capsules in the control arm. The trial’s primary goal is to assess overall survival, with key secondary endpoints including objective response rate and time to symptom deterioration.
Hepatocellular carcinoma stands as the most prevalent type of primary liver cancer and is among the leading causes of cancer-related deaths worldwide. Often diagnosed in advanced stages, treatment options for HCC have been limited, generally yielding poor outcomes. With HBV, HCV infections, metabolic syndrome, and nonalcoholic steatohepatitis (NASH) as primary causes, the incidence of HCC is expected to rise, underscoring the importance of innovative therapies like the combination of Opdivo and Yervoy in addressing this growing challenge.
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.
