Merck has reported successful results from its Phase III trial of Keytruda, a liver cancer treatment. The primary goal was overall survival in Asian patients with the most common form of liver cancer, hepatocellular carcinoma.
Keytruda works by triggering T lymphocytes that could impact both tumor cells and healthy cells. The drug hinders the interaction between receptors (those denoted death receptor-1, or PD-1) and its ligands.
This treatment boosts the immune system and allows the body to fight off tumor cells.
The trial at hand addressed Keytruda's performance as compared to a placebo treatment involving sorafenib or oxaliplatin on measures of response duration and disease control rate. The study employed a randomized, placebo controlled study. The subjects in both groups received either an intravenous dose of Keytruda every 3 weeks (for up to 35 total doses) or the placebo treatments.
The trial found that Keytruda, when combined with supportive care, provided a statistically significant increase in overall survival rates versus the placebo.
The trial also met secondary endpoints of progression free survival and objective response rate.
No new safety concerns arose during the third phase of the trial.
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