Ipsen ends P3 trial on liver cancer early due to strong data
Ipsen and Exelixis, partners in developing Cabometyx (cabozantinib), have revealed that they have cut short a Phase 3 trial into the benefit of the drug in liver cancer, after the treatment hit its primary endpoints.
Cabometyx is currently approved for the use in the treatment of advanced renal cell carcinoma and the partners are looking to expand this with a trial into its use in advanced hepatocellular carcinoma. They were rewarded with the treatment being able to display a 2.2 month improvement to median overall survival against placebo, boosting it from 8.0 to 10.2 months.
Further than this, there was a median progression-free survival improvement of 5.2 months on those taking Cabometyx, compared with 1.9 months on placebo. Those treated with the drug had received it as a second- or third-line treatment.
Hepatocellular carcinoma is the most common form of cancer and occurs in people with chronic liver diseases. The condition is often diagnosed late and the median survival span for patients following diagnosis found to be between six and 20 months.
This is why even the modest boost to overall survival that the companies were able to show is strong enough for them to take the data onto regulators. In addition, in a subgroup analysis of patients who had received only Bayer’s Nexavar, median overall survival was 11.3 months with Cabometyx compared with 7.2 months with placebo, a four month advantage.
“We are excited by the potential benefit cabozantinib may offer to patients with previously treated advanced hepatocellular carcinoma,” said Gisela Schwab, President and Chief Medical Officer of Exelixis.
Ipsen’s General Manager in the UK & Ireland, Ewan McDowall, said of the research results: “At Ipsen we firmly believe that patients don’t have time to wait, so are delighted that the Phase 3 results from the Celestial trial have concluded that Cabometyx significantly improves overall survival in patients living with advanced HCC following prior treatment – an area where trial failures are more common than successes due to the challenging nature of this type of liver cancer. These data will form the basis of our licence submission, bringing us one step closer to making this positive new treatment available to patients in the UK & Ireland. We are committed to continuing with our mission of developing our oncology portfolio with medicines that improve treatment outcomes and patients’ lives.”
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