On 14 January 2019, the FDA approved cabozantinib (Cabometyx®, Exelixis) for hepatocellular carcinoma (HCC) patients previously treated with sorafenib.

CELESTIAL

The randomised, double-blind, placebo-controlled, multicentre CELESTIAL trial randomised 707 HCC patients with Child-Pugh Class A liver impairment and previously treated with sorafenib in a 2:1 ratio to either receive cabozantinib (N=470) or placebo (N=237) until disease progression or unacceptable toxicity. The primary endpoint was the overall survival (OS) and secondary endpoints included the progression-free survival (PFS) and overall response rate (ORR) assessed by the investigators per RECIST1.1.

The median OS measured 10.2 (95% CI, 9.1-12.0) months in the cabozantinib-arm and 8 (95% CI, 6.8-9.4) months in the placebo-arm (HR=0.76; 95% CI, 0.63-0.92; P=0.0049). The median PFS were 5.2 months (95% CI, 4.0-5.5) and 1.9 months (95% CI, 1.9-1.9) for the cabozantinib- and placebo-groups, respectively (HR=0.44; 95% CI, 0.36-0.52; P<0.001). Finally, the ORRs were 4% (95% CI, 2.3-6.0) and 0.4% (95% CI, 0.0-2.3), again for the cabozantinib-arm and placebo-arm, respectively.

Safety

Common adverse reactions, occurring in ≥25% of patients receiving cabozantinib in clinical trials, include diarrhoea, fatigue, decreased appetite, palmar-plantar erythrodysesthesia, nausea, hypertension, and vomiting.

Full prescribing information Cabometyx.

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

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