Agios Pharmaceuticals Inc.'s cancer drug Tibsovo helped certain patients with a type of bile duct cancer to live longer without the disease worsening in a late-stage study, data presented at the European Society for Medical Oncology's 2019 scientific meeting showed.
The Cambridge, Mass.-based biopharmaceutical company evaluated Tibsovo, or ivosidenib, against placebo in the phase 3 study, named ClarIDHy, in 185 cholangiocarcinoma patients with a mutation called isocitrate dehydrogenase 1, or IDH1. The patients in the study had previously undergone one or two therapies.
Cholangiocarcinoma is a cancer of the bile ducts within and outside of the liver. An estimated 8,000 people are diagnosed with this type of cancer in the U.S. every year.
In the study, 124 patients were given different doses of Tibsovo and 61 were given placebo. From the placebo group, 35 patients were shifted to Tibsovo after their disease progressed.
Results from the trial showed that patients given Tibsovo lived for a median of 2.7 months without any progression in their cancer compared to 1.4 months for those who received a placebo.
Also, 32% of patents on Tibsovo saw no disease progression at six months and 22% did not see their cancer progress at 12 months. In comparison, no patients on placebo were free from disease progression beyond these time periods.
Only 2% of patients on Tibsovo saw a reduction in their cancer, while the disease remained stable — neither decreasing nor increasing in severity — in 51% of these patients. This compares to 28% of patients on placebo with stable disease.
Patients on Tibsovo survived for a median of 10.8 months versus 9.7 months for placebo. The median survival for the placebo group would be six months if it is assumed that placebo subjects never crossed over to Tibsovo.
Agios plans to submit an application for Tibsovo to the U.S. Food and Drug Administration by the end of the year for treating patients with cholangiocarcinoma, said Chief Medical Officer Chris Bowden. Currently, Tibsovo is not approved anywhere in the world to treat this advanced bile duct cancer.
Tibsovo is approved in the U.S to treat certain patients with acute myeloid leukemia, a type of blood cancer.
Agios' stock price was down 5.95% to $32.40 as of market close on Sept. 30.
The European Society for Medical Oncology is holding its 2019 scientific meeting in Barcelona, where more than 3,900 study abstracts have been submitted for review by oncology professionals from around the world.
