CheckMate 9DW

CheckMate 9DW, trial NCT04039607 sponsored by Bristol Myers Squibb and reported in 2024, showed that dual checkpoint blockade with nivolumab plus ipilimumab gives the longest median survival yet seen in a first-line liver cancer trial. It randomised 668 patients with unresectable hepatocellular carcinoma to the combination or to lenvatinib or sorafenib, met its primary overall survival endpoint, and produced a much higher response rate with far more durable responses, leading to FDA approval in April 2025, at the cost of more immune-related toxicity than single-agent regimens. OnCo links it to PD-1 and CTLA-4 as targets and to nivolumab and ipilimumab. Whether the extra toxicity is worth it for all patients, or whether a biomarker could pick those who need the CTLA-4 component, is the open question.