Ipsen’s liver cancer treatment clears phase III trial

Ipsen and partner Exelixis are on track to file cancer treatment Cabometyx (cabozantinib) for a new liver cancer indication in the first half of next year, following positive phase III trial results.

The randomised, double-blind CELESTIAL study was set up to test Cabometyx in 760 patients with advanced hepatocellular carcinoma (HCC), the sixth most common form of cancer with around 800,000 new cases diagnosed each year.

Data showed cabozantinib provided a ‘statistically significant’ and ‘clinically meaningful’ improvement of overall survival (OS) compared to placebo.

Alexandre Lebeaut, Ipsen’s chief scientific officer, said: “Liver cancer is one of the leading causes of cancer deaths worldwide and more effective treatment options are urgently needed.

“We are pleased to report that in the CELESTIAL clinical study cabozantinib has been shown to provide a survival benefit and therefore has the potential to bring a new oral systemic treatment to previously treated patients with advanced liver cancer.”

The once-daily oral drug comprises of a small molecule inhibitor of receptors - including VEGFR, MET, AXL and RET - which are involved in normal cellular function and pathologic processes such as invasiveness, metastasis and drug resistance.

The duo has already seen success with the drug after gaining a US FDA approval to treat patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Additionally, the drug received the European go ahead for the treatment of RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.

Ipsen will now “evaluate potential next steps in the development strategy” for cabozantinib outside the US and Japan as a treatment for advanced HCC in patients who have been previously treated.