US major Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 9th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used as a monotherapy to treat hepatocellular carcinoma (HCC) previously treated with sorafenib or oxaliplatin.
Approval Based on KEYNOTE-394 Study
The approval is based on the results of the Phase III KEYNOTE-394 study, which showed in January 2022 that compared with the best supportive treatment combined with a placebo, Keytruda produced a 14.6-month overall survival (OS) (95% CI, 12.6-18.0) and reduced the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]; P=0.0180). In terms of long-term survival benefits, Keytruda and the placebo delivered a respective 34.3% and 24.9% two-year survival rate.
Previous Approvals and Market Presence
First approved in China in July 2018, Keytruda has since been approved to treat melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer, among others. According to the World Health Organization, China had 410,000 new cases of liver cancer in 2020, accounting for 45% of the global total, with about 391,000 deaths from liver cancer in the country, second only to lung cancer.
Future Outlook
The latest indication approval for Keytruda underscores Merck’s ongoing commitment to expanding the therapeutic applications of its PD-1 inhibitor. By addressing the significant unmet medical needs in hepatocellular carcinoma, Keytruda aims to improve patient outcomes and contribute to the management of this challenging disease.-Fineline Info & Tech
