Merck's Pembrolizumab Receives First-in-Class Global Approval in China for Combination Therapy with Lenvatinib and TACE in Unresectable, Non-Metastatic Hepatocellular Carcinoma

Jun 13, 2025 10:39 CST Updated 10:39

MSD

Pharmaceutical R&D and Manufacturer

On June 13, MSD announcedIts PD-1 inhibitor Pembrolizumab(Product name: Keytruda®)Has obtained the approval of the National Medical Products Administration of China（NMPA）Approval,Combination of Lenvatinib and Transarterial Chemoembolization（TACE）, used forTreatment of patients with unresectable, non-metastatic hepatocellular carcinoma。

Screenshot source: Official WeChat account of the company

The press release pointed out,The approval of this combination therapy is based on the data from the international multicenter clinical trial LEAP-012, in which Chinese patients accounted for 43.3% of the enrolled participants. This is also the indication forFirst Approval Worldwide, will bring new options for the clinical treatment of hepatocellular carcinoma in China.

LEAP-012 is aPhase III multicenter, randomized, double-blind, positive-controlled clinical study, aimed atEvaluation of Lenvatinib and Pembrolizumab Combined with Transarterial Chemoembolization in Subjects with Unresectable/Non-Metastatic Hepatocellular Carcinoma（TACE）Compare the safety and efficacy with TACE.The primary endpoints of the study are PFS and OS.。

Screenshot source: Insight database

The latest data released by the National Cancer Center shows that in 2022, China had 367,700 new cases of liver cancer and 316,500 deaths, making it the fourth most commonly diagnosed cancer and the second deadliest cancer in China. From 2012 to 2015, the five-year survival rate for liver cancer patients in China was only 12.1%. Approximately 70% of patients are diagnosed at middle or late stages, having already missed the opportunity for curative surgical resection.TACE, as an important treatment modality at present, still has significant unmet medical needs.. This timePembrolizumab and Lenvatinib Combination Therapy Approved in China, will bring new options for the clinical treatment of hepatocellular carcinoma in China.

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Disclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment options. If needed, please consult and contact正规医疗机构.

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