Combination Therapy for Hepatocellular Carcinoma Fails to Achieve Trial Endpoints

According to a story from Market Watch, the drug companies Merch and Eisai recently announced an update on their phase 3 clinical trial. This clinical trial was evaluating a combination therapy of Merck’s anti-PD-1 therapeutic KEYTRUDA and Eisai’s LENVIMA, a multiple receptor inhibitor of tyrosine kinase, as a treatment for hepatocellular carcinoma. This treatment was compared alongside LENVIMA as a monotherapy. The approach was used as a first line treatment for patients whose tumors could not be removed with surgery.

About Hepatocellular Carcinoma

Hepatocellular carcinoma is a type of liver cancer. Although generally considered rare, at least in developed countries, it is the most common type of cancer to originate in the liver in adults and is also the most common cause of death for people who develop cirrhosis. Risk factors are generally any condition that can lead to long term liver damage and cirrhosis, such as certain genetic disorders, chronic hepatitis, type 2 diabetes, nonalcoholic steatohepatitis, and severe alcohol abuse. The cancer is associated with common symptoms of liver dysfunction and damage, such as jaundice, fatigue, abdominal swelling, nausea and vomiting, bruising easily, abdominal pain, loss of appetite, and weight loss. Treatment may include kinase inhibitors, surgery, liver transplant, arterial catheters, and ablation. Survival rates are poor; cancer that cannot be removed with surgery is usually lethal within a year. To learn more about hepatocellular carcinoma, click here.

Study Results

The endpoints of this study were overall survival and progression-free survival. Unfortunately, the Keytruda and Lenvima combination failed to achieve these endpoints. In comparison to monotherapy with Lenvima, the combination appeared to show marginal improvements in these measures, but according to the statistical parameters set for this clinical trial, these improvements were not statistically significant. 

Lenvima alone is already approved around the world for unresectable hepatocellular carcinoma and displayed better median overall survival in this study than in previous trials. While the results with the combination approach were not what Merch and Eisai were hoping for, they plan to continue evaluating this two part treatment in other types of cancer.

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