Ono Pharmaceutical Receives Approval for Opdivo® and Yervoy® Combination to Treat Advanced Liver Cancer
Monday, July 28, 2025
Ono Pharmaceutical has announced that it has received approval from the Taiwan Food and Drug Administration (TFDA) for the combination use of Opdivo® (nivolumab) and Yervoy® (ipilimumab).
Hepatocellular carcinoma is the most common form of primary liver cancer, accounting for around 90% of all cases. Globally, liver cancer is the third leading cause of cancer-related death. In 2022, there were an estimated 866,000 new cases and around 758,000 deaths from liver cancer worldwide.
In Taiwan, approximately 9,000 new cases and 8,000 deaths were reported in the same year. While many cases have historically been linked to viral hepatitis B or C, non-viral causes of liver disease are increasingly contributing to new cases, often leading to late-stage diagnoses and limited treatment options.
The approval covers the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), a common form of liver cancer.
The decision is supported by findings from the global Phase 3 CheckMate -9DW study, which compared Opdivo plus Yervoy with standard treatments lenvatinib or sorafenib in patients who had not received prior systemic therapy.
The study demonstrated that the combination therapy significantly improved overall survival, with patients receiving Opdivo and Yervoy living a median of 23.7 months compared to 20.6 months for those on lenvatinib or sorafenib. This represents a 21% reduction in the risk of death. The safety results were consistent with previous data, and no new safety concerns were reported.
The CheckMate -9DW trial was a large, international study involving 668 participants. Patients were randomly assigned to either receive the combination immunotherapy or one of the oral treatments used in the control group.
In the combination group, patients were given Opdivo and Yervoy for up to four doses, followed by Opdivo alone once every four weeks. Key study outcomes included overall survival, response rates, and time to worsening of symptoms.
Source: ono-pharma.com
