Agios’ Drug Tibsovo Prolongs Progression-Free Survival in Phase 3 Cholangiocarcinoma Trial by only 2 Months, Shares Down by 6%
Agios Pharmaceuticals today announced the presentation of phase 3 clinical trial data for Tibsovo. The drug is currently beeing evaluated for the treatment of patients with IDH1-mutant bile duct cancer. Tibsovo is already approved for treatment of IDH1-mutated acute myeloid leukemia.
The Cambridge-based US company Agios Pharmaceuticals today announced the data from its phase III ClarIDHy trial of Tibsovo (Ivosidenib) in patients with IDH1-mutated advanced cholangiocarcinoma. Tibsvo is an IDH1 inhibitor which is already approved for the treatment of relapsed or refractory IDH1 mutation positive acute myeloid leukemia.
According to Agios, an improvement of 2.7 months in progression-free survival was observed for patients treated with Tibsovo compared to 1.4 months for placebo. Furthermore, the estimated rates of progression-free survival at 6 months and 12 months were 32 percent and 22 percent, respectively. None of the patients in the placebo group were free from progression after after 6 and 12 months.
Although the company stated that the results were statistically significant, a difference in progression-free surivival of only 1.3 months is rather disappointing. As a result, shares of Agios Pharmaceuticals are down by almost 6% to $32.40 today.
The full press release of Agios Pharmaceuticals can be found here.