MSD Wins NMPA Approval for Keytruda-Lenvima Combo in Hepatocellular Carcinoma

MSD Wins NMPA Approval for Keytruda-Lenvima Combo in Hepatocellular Carcinoma

US-based Merck, Sharp & Dohme (MSD; NYSE: MRK) announced that China’s National Medical Products Administration (NMPA) has approved the combination of its anti-PD-1 therapy Keytruda (pembrolizumab) with Lenvima (lenvatinib) and transarterial chemoembolization (TACE) for unresectable, non-metastatic hepatocellular carcinoma (HCC). This marks the world’s first approval for this treatment approach. The approval is based on data from the global, multi-center Phase III LEAP-012 study, in which Chinese patients accounted for 43.3% of participants.

Therapeutic Approval and Significance
Previously approved in China for HCC patients who had been treated with sorafenib or oxaliplatin-containing chemotherapy, Keytruda now offers a new therapeutic option for intermediate-advanced HCC patients ineligible for surgical resection.

Liver Cancer in China
In 2022, China recorded 367,700 new cases of liver cancer and 316,500 deaths, making it the fourth most prevalent and the second leading cause of cancer-related deaths in the country. From 2012 to 2015, the five-year survival rate for liver cancer patients in China was only 12.1%. Approximately 70% of patients were at intermediate-advanced stages when they sought medical treatment, having lost the opportunity for radical treatment and surgical resection.-Fineline Info & Tech