Cometriq Side Effects May Increase Risk of Hypertension, Other Adverse Events: Study

New research suggests that side effects of the cancer drugs Cabometyx and Cometriq could result in high blood pressure and a number of other health problems, while only extending the lives of individuals with liver cancer by about two months. 

In a study published earlier this month in the New England Journal of Medicine, researchers from the U.K. report that while Cabometyx appears to increase overall survival and progression-free survival in the treatment of liver cancer, it doubles the risk of severe adverse events when compared to a placebo.

Cabometyx and Cometriq (cabozantinib) are approved for the treatment of thyroid cancer and as a second-line treatment for renal cell carcinoma. In this study, however, researchers looked at how the drug responded in the treatment of advanced hepatocellular carcinoma; a form of liver cancer, when patients failed to respond to Nexavar, which is a first-line treatment.

Researchers conducted a randomized, double-blind phase 3 clinical trial that involved 707 patients. They looked for survival rates and adverse events.

According to the findings, treatment with cabozantinib-based drugs resulted in a 10.2 month median overall survival for those with advanced stages of hepatocelluar carcinoma. That compared to 8 months survival for those given a placebo. Cabometyx and Cometriq treatment lengthened the patients’ lives by just over two months.

However, that came with a number of adverse side effects, the most common of which were palmer-plantar erythrodysesthesia, hypertension, increased asparatate aminotransferase level, fatigue and diarrhea. In the case of hypertension, 16% of those given the cancer drug were affected, compared to just 2% of those given the placebo.

“Among patients with previously treated advanced hepatocellular carcinoma, treatment with cabozantinib resulted in longer overall survival and progression-free survival than placebo,” the researchers concluded. “The rate of high-grade adverse events in the cabozantinib group was approximately twice that observed in the placebo group.”

Cabozantinib was first granted orphan drug status in the U.S. by the FDA in January 2011. It was marketed as Cometriq in November 2012 in the U.S. Both Cometriq and Cabometyx are manufactured and marketed by Exelixis.