Bristol Myers Squibb reports CheckMate -9DW trial of Opdivo plus Yervoy meets primary endpoint of OS to treat advanced HCC

Bristol Myers Squibb has announced positive findings from the phase 3 CheckMate -9DW trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line therapy for advanced hepatocellular carcinoma (HCC) patients without prior systemic treatment. The trial met its primary endpoint of improved overall survival (OS) compared to sorafenib or lenvatinib, as chosen by investigators, in an interim analysis.

This combination therapy demonstrated statistically significant and clinically meaningful OS improvement, with a consistent safety profile and manageable side effects. No new safety concerns were identified.

The company plans to conduct a comprehensive data analysis, sharing results at an upcoming medical conference and engaging with health authorities. The phase 3 trial compared Opdivo plus Yervoy to sorafenib or lenvatinib monotherapy in approximately 668 HCC patients. Primary endpoints included OS, with secondary measures like objective response rate and time to symptom deterioration.

Hepatocellular carcinoma (HCC) constitutes 90% of primary liver cancers, often diagnosed late, limiting treatment options. Bristol Myers Squibb's commitment to advancing cancer care through scientific innovation is evident, with Opdivo and Yervoy offering promising avenues for improved patient outcomes.