Success for phase III ClarIDHy trial of Tibsovo in previously treated cholangiocarcinoma
Agios Pharmaceuticals, Inc. has announced that the global Phase III ClarIDHy trial of Tibsovo (ivosidenib) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation met its primary endpoint. Treatment with Tibsovo demonstrated a statistically significant improvement in progression-free survival (PFS) by independent radiology review compared with patients who received placebo.
The safety profile observed in the study was consistent with previously published data. A full analysis of the ClarIDHy trial will be submitted for presentation at the European Society for Medical Oncology Congress taking place in Barcelona, Spain from September 27-October 1, 2019.
The company plans to submit a supplemental new drug application for Tibsovo in previously treated IDH1 mutant cholangiocarcinoma by the end of 2019.
The study was designed with 96% power to detect a hazard ratio of 0.5 for PFS (Tibsovo vs. placebo), with a one-sided alpha of 0.025. Thermo Fisher Scientific is providing next-generation sequencing to detect IDH1 mutations for all tumor samples as inclusion criteria for enrollment in the study and will develop and commercialize the validated companion diagnostic.
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