NICE recommends Cabometyx (cabozantinib) for hepatocellular carcinoma
Cabometyx (cabozantinib) has been recommended by NICE for previously treated hepatocellular carcinoma (HCC) in adult patients. The CELESTIAL phase 3 trial has shown significant improvements in progression-free survival as well as overall survival when compared with a placebo group.
Ipsen UK gratefully received this recommendation from NICE for the use of its drug to treat advanced HCC, a type of primary liver cancer, in patients who have already been treated with sorafenib, with a Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.1. The phase 3 CELESTIAL trial had generally positive results which presumably influenced this recommendation, with the trial including a patient population who received cabozantinib in second- or third-line treatment with sorafenib.
The primary endpoint of this trial was overall survival, with the new drug providing a statistically significant improvement in this area, when compared to the placebo group. The median overall survival with cabozantinib was 10.2 months, while the placebo group only saw 8.0 months. Similarly, cabozantinib appeared to improve progression-free survival, with the median in this area being 5.2 months, while the placebo only had 1.9 months.
Vanessa Hebditch, director of communications and policy at the British Liver Trust, commented: “People living with the most common form of primary liver cancer, HCC, have a poor prognosis and there are very few treatments available. Often, the disease is diagnosed so late that palliative care is the only option. The nurses on the British Liver Trust’s helpline hear every day from patients who are completely devastated. They live with uncertainty, hopelessness, and often stigma and isolation due to the image of liver cancer. Treatments that buy extra time can not only positively impact those individuals but can also have a huge positive impact on families and the wider community, so today’s recommendation is an important step forward in the treatment of HCC.”
Professor Tim Meyer, professor of experimental cancer medicine at UCL Cancer Institute and honorary consultant in medical oncology at the Royal Free Hospital, added: “HCC is the third leading cause of cancer death worldwide and has one of the lowest five-year survivals of all cancers. For patients with advanced disease, treatment options remain limited, and outcomes are poor. Today’s recommendation by NICE will make cabozantinib available to such patients and provides an important addition to the therapeutic landscape for HCC. Cabozantinib has been proven to improve survival, slow disease progression and delay deterioration in symptoms when used as a second- or third-line treatment, and the decision to allow its use will be welcomed by doctors treating this challenging disease.”
Pharmaceutical Industry news, analysis and insights