Agios Pharmaceuticals Inc.'s Tibsovo helped patients with a type of bile duct cancer live longer without the disease worsening in a late-stage study.
The Cambridge, Mass.-based biopharmaceutical company evaluated Tibsovo, or ivosidenib, against placebo in a phase 3 trial, named ClarIDHy, in previously treated patients with cholangiocarcinoma with a mutation called isocitrate dehydrogenase 1, or IDH1. These patients had undergone one or two prior lines of other therapies.
Cholangiocarcinoma is cancer that forms in the bile ducts that connect the liver to the gallbladder and the small intestine.
Surgical resection is the primary treatment option, and there is no standard second- and third-line treatment for patients with advanced cholangiocarcinoma, CStone Pharmaceuticals, a partner of Agios, said in a May 23 press release. CStone added that China is among the countries with the highest incidence of cholangiocarcinoma.
The companies said the drug demonstrated a statistically significant improvement in progression-free survival compared to placebo. Progression-free survival, or how long a patient lives without the disease worsening, is a measure to see how well a cancer treatment works.
The safety profile of Tibsovo was consistent with previously seen data on the drug.
Agios plans to submit a supplemental new drug application for Tibsovo, which has been approved by the U.S. Food and Drug Administration to treat certain types of blood cancer, by the end of the year for treating patients with cholangiocarcinoma.
The company intends to present a full analysis of the trial at the European Society for Medical Oncology Congress later in the year.
In June 2018, Shanghai-based CStone had entered into a collaboration and license agreement with Agios to develop and commercialize Tibsovo in the Greater China region.