Express significantly prolongs the lives of Asian liver cancer patients, and Keytruda reaches the phase 3 primary clinical endpoint

▎Editor of WuXi AppTec Content Team On September 27, 2021, Merck & Co.
(MSD) announced that in Asian patients with advanced hepatocellular carcinoma (HCC) who have received sorafenib (sorafenib), the heavyweight PD-1 antibody A phase 3 clinical trial of the therapy Keytruda reached the primary endpoint of overall survival (OS)
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Compared with placebo plus best supportive care (BSC), Keytruda plus BSC resulted in a statistically significant improvement in patients' OS
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 Keytruda is a humanized monoclonal antibody that can block the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby stimulating the anti-cancer activity of T lymphocytes
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Keytruda was granted accelerated approval by the U.
S.
FDA in November 2018 for the treatment of hepatocellular carcinoma patients previously treated with sorafenib
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This randomized double-blind phase 3 clinical trial enrolled 453 Asian patients.
In addition to the primary endpoint of the trial, the trial also reached the key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR)
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In addition, no new safety signals were observed
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Hepatocellular carcinoma is the most common type of primary liver cancer and the sixth most common cancer in the world
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It is estimated that in 2020, there will be more than 905,000 new cases of liver cancer worldwide and more than 830,000 deaths.
This is one of the main causes of cancer deaths worldwide
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Risk factors for liver cancer include gender, race, chronic viral hepatitis, cirrhosis, alcohol consumption and metabolic syndrome, etc.
It is often at an advanced stage when diagnosed, and its five-year survival rate is less than 15%
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"Hepatocellular carcinoma is usually diagnosed at an advanced stage and is one of the cancers with the highest mortality rate for solid tumors
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In addition to sorafenib, anti-PD-1 monotherapy for this disease still has significant unmet medical needs
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" Merck Laboratories Clinical Research Vice President Dr.
Scot Ebbinghaus said, “It is very encouraging that Keytruda significantly improved the overall survival of patients in this trial, and we look forward to discussing this result with regulatory agencies as soon as possible
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” References: [1] Merck Announces Keytruda® (pembrolizumab) Met Primary Endpoint of Overall Survival (OS) in Patients with Advanced Hepatocellular Carcinoma Previously Treated with Sorafenib.
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