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).

小野制药宣布已获得台湾食品药物管理局（TFDA）批准，将Opdivo®（nivolumab）与Yervoy®（ipilimumab）联合使用。

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.

肝细胞癌是最常见的原发性肝癌形式，约占所有病例的90%。在全球范围内，肝癌是癌症相关死亡的第三大原因。2022年，全球估计有866,000例新发肝癌病例，约758,000人死于肝癌。

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..

在台湾，同年报告了大约 9,000 例新病例和 8,000 例死亡。虽然历史上许多病例与乙型或丙型病毒性肝炎有关，但非病毒性肝病原因日益成为新病例的致病因素，常导致晚期诊断和治疗选择有限。

The approval covers the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), a common form of liver cancer.

该批准涵盖了无法切除或转移性肝细胞癌（HCC）成人患者的一线治疗，这是一种常见的肝癌形式。

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.

该决定得到了全球三期 CheckMate -9DW 研究结果的支持，该研究比较了 Opdivo 加 Yervoy 与标准治疗药物仑伐替尼或索拉非尼在未接受过先前系统治疗的患者中的效果。

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..

该研究显示，联合疗法显著改善了总生存期，接受Opdivo和Yervoy治疗的患者中位生存期为23.7个月，而接受仑伐替尼或索拉非尼治疗的患者为20.6个月。这代表死亡风险降低了21%。安全性结果与之前的数据一致，没有报告新的安全问题。

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.

CheckMate -9DW 试验是一项大型国际研究，涉及 668 名参与者。患者被随机分配接受组合免疫疗法或对照组中使用的口服治疗之一。

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.

在联合治疗组中，患者接受最多四剂Opdivo和Yervoy，随后每四周单独使用Opdivo一次。关键研究结局包括总生存期、应答率以及症状恶化的时间。