The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC), a primary liver cancer.
The approval is anchored in the outcomes from the open-label randomised Phase III CheckMate-9DW trial, in which the combination showed significant overall response rate (ORR) and overall survival (OS) against the comparator arm.
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The trial compared the combo against the investigator’s choice of tyrosine kinase inhibitor monotherapy – either lenvatinib or sorafenib in the unresectable or advanced HCC patient group, who had not undergone previous systemic therapy.
Its primary endpoint is OS, with secondary endpoints objective response rate and time to symptom deterioration.
The latest decision by the agency grants full approval to the regimen and extends its use to the first-line treatment setting, reflecting the CheckMate-9DW trial’s findings.
BMS noted that the trial was not structured to independently evaluate Opdivo plus Yervoy against lenvatinib or sorafenib alone.
BMS oncology commercialisation senior vice-president Wendy Short Bartie stated: “Bringing Opdivo plus Yervoy to patients with HCC in the first-line setting is a testament to our ongoing commitment to research and delivering important progress for people living with cancer.
“Today’s approval builds on the legacy of our dual immunotherapy and the value it has brought to patients for years. We are thrilled to add this indication for this important therapy – our second approval for Opdivo plus Yervoy in the gastrointestinal space this week alone – and look forward to providing a new first-line treatment option to patients in need.”
In 2020, the combination received accelerated approval from the US regulator based on the Phase I/II CheckMate-040 trial outcomes.
It had been recognised as a second-line treatment for advanced HCC patients treated with sorafenib.
In March 2025, BMS agreed to acquire 2seventy bio, the company’s longtime cell therapy partner, in a $286m deal.
