Primary End Point Achieved

Agios Announces the Randomized Phase 3 ClarIDHy Trial of TIBSOVO® (ivosidenib) Achieved its Primary Endpoint in Previously Treated IDH1 Mutant Cholangiocarcinoma Patients – TIBSOVO® Demonstrated a Statistically Significant Improvement in Progression-Free Survival Compared to Placebo – “Advanced cholangiocarcinoma is a life-threatening disease with no currently approved treatment options,” said Chris Bowden, M.D., chief medical officer at Agios. “The data from the ClarIDHy Phase 3 trial demonstrate the clinically significant benefit of TIBSOVO® in patients with this challenging disease who harbor the IDH1 mutation.

“The data from the ClarIDHy Phase 3 trial demonstrate the clinically significant benefit of TIBSOVO® in patients with this challenging disease who harbor the IDH1 mutation. We are committed to working with regulators to bring this potential treatment option to patients as quickly as possible. We thank the patients and physicians who participated in the ClarIDHy study, without whom this important advancement would not be possible.”