Abstract Number – LBA4008

Title – Nivolumab and ipilimumab combination preparing to enter the first-line hepatocellular carcinoma realm

Commentary – The latest results from CheckMate 9DW met its primary endpoint of improved overall survival compared to the investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis. Bristol Myers Squibb is all set to present the latest results in the upcoming presentation to put this combination in the hepatocellular carcinoma conversation.

Executive Summary – Recently, Bristol Myers Squibb announced that the first-line treatment with nivolumab and ipilimumab significantly improved overall survival in advanced hepatocellular carcinoma patients compared to sorafenib or lenvatinib, meeting the trial's primary endpoint. The interim analysis confirmed the combination's manageable safety profile, consistent with prior data, with no new safety signals. The latest results which are to be presented at the upcoming ASCO meeting, reinforce the combination’s efficacy and competitive potential in this indication.

Main Content – In March 2020, the US FDA granted accelerated approval to the combination of nivolumab and ipilimumab for the treatment of patients with hepatocellular carcinoma who have received prior therapy with sorafenib. The regulatory decision was supported by data from the Phase I/II CheckMate-040 trial. CheckMate 9DW was designed as a confirmatory trial following the accelerated approval.

In March 2024, Bristol Myers Squibb announced that the treatment with first-line nivolumab in combination with ipilimumab resulted in a statistically significant and clinically meaningful improvement in overall survival compared with the investigator’s choice of sorafenib or lenvatinib in patients with advanced hepatocellular carcinoma, meeting the primary endpoint of the Phase III CheckMate 9DW trial. Findings from the prespecified interim analysis of the trial confirmed that the combination had a manageable safety profile that was consistent with previously reported data. No new safety signals were observed. Now, the company plans to present the topline results from the Phase III trial, however we believe that to break into this area, an exceptional performance is required.

Conclusion: The Phase III CheckMate 9DW trial demonstrated that first-line treatment with nivolumab and ipilimumab significantly improves overall survival in patients with advanced hepatocellular carcinoma compared to sorafenib or lenvatinib, confirming the combination's efficacy and manageable safety profile. With no new safety signals observed, the upcoming presentation at ASCO is poised to solidify its potential as a competitor in this indication.