Agios lines up solid PhIII data to back Tibsovo's use in bile duct cancer — ahead of planned sNDA
BARCELONA — A little more than a year after securing the first FDA approval for ivosidenib — now on the market as Tibsovo for acute myeloid leukemia — Agios has lined up another slate of data in a type of solid tumor to take to regulators by the end of the year.
The key takeaway: For a genetically-defined group of patients with cholangiocarcinoma, or bile duct cancer, who have gone through one to two rounds of chemotherapy, ivosidenib prolonged progression-free survival, with a 6-month PFS of 32% and a 12-month rate of 22% while all patients on the placebo arm had progressed by 6 months.
In terms of numbers, the median PFS on ivosenibd was 2.7 months compared to 1.4 months on placebo — a hazard ratio of 0.37 (p<0.001) that Agios says is remarkable for this aggressive form of cancer.
“I think that when you look at the curve, it really tells the story as opposed to focusing on the median,” said Susan Pandya, VP of clinical development. Besides, “our overall sense of how chemotherapy performs in this setting is that OS outcome is around 6 months in patients who have second-line chemotherapy. So to see a progression-free survival rate of 32% at 6 months is really compelling.”
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