Exelixis’ liver cancer drug cabozantinib (Cabometyx) has met its primary end point in the global phase 3 Celestial trial.
Cabozantinib has achieved its primary endpoint of overall survival (OS) through demonstrating a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC).
Cabometyx, which is the tablet formulation of cabozantinib, includes targets such as MET, AXL and VEGFR-1, -2 and -3.
Celestial is a randomized and global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib.
According to the company, the safety data in the study were consistent with the established profile of cabozantinib.
Exelixis is planning to submit a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) based on the current results.
In March this year, the company secured orphan drug status from the FDA for cabozantinib to treat advanced HCC.
The double-blind and placebo-controlled study has been conducted at more than 100 sites in 19 countries.
It is designed to enroll 760 patients with advanced HCC who received prior sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function.
The trial’s secondary endpoints comprised of objective response rate and progression-free survival, while exploratory endpoints include patient-reported outcomes, biomarkers and safety.
Exelixis product development and medical affairs president and CEO Dr Gisela Schwab said: “We are excited that these positive results from the phase 3 CELESTIAL trial bring us one step closer to the potential of offering previously treated patients with this aggressive form of advanced liver cancer a much-needed new treatment option.”
“This is an important milestone for the cabozantinib development program; we are committed to studying cabozantinib in a range of tumor types as part of our mission to deliver medicines that improve treatment outcomes and give patients hope for the future.”