Agios data from Phase 3 ClarIDHy trial shows significant improvement in PFS
Agios Pharmaceuticals presented data from the global Phase 3 ClarIDHy trial of TIBSOVO in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 mutation in a Presidential Symposium at the European Society for Medical Oncology Congress. Results from the ClarIDHy trial demonstrated a statistically significant improvement in progression-free survival by independent radiology review of 2.7 months among patients randomized to TIBSOVO compared with 1.4 months among placebo patients. The safety profile observed in the study was consistent with previously published data. "Advanced cholangiocarcinoma is an aggressive disease oftentimes characterized by rapid progression following multiple lines of therapy, and there are no currently approved treatments," said Ghassan Abou-Alfa, M.D., medical oncologist at Memorial Sloan Kettering Cancer Center, who presented the data at ESMO. "The ClarIDHy study is the first randomized trial in previously treated IDH1 mutant cholangiocarcinoma patients and demonstrates that TIBSOVO provides significant improvement in PFS compared to placebo, while also showing a favorable trend in overall survival. These critical data also provide strong justification for genomic testing in cholangiocarcinoma patients where a targeted therapeutic approach may provide benefit."