Clinical Trials

Date: 2015-10-16

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Celgene (USA - NJ) Agios Pharmaceuticals (USA -MA)

Product: AG-221 (enasidenib)

Action mechanism:

enzyme inhibitor/isocitrate dehydrogenase inhibitor. AG-221 is an orally available, selective, potent inhibitor of the mutated isocitrate dehydrogenase (IDH) 2 protein, making it a highly targeted investigational medicine for the potential treatment of patients with cancers that harbor an IDH2 mutation. AG-221 has received orphan drug and fast track designations from the FDA. In September 2013, Agios initiated a Phase 1 multicenter, open-label, dose escalation clinical trial of AG-221 designed to assess the safety and tolerability of AG-221 in advanced hematologic malignancies. In October 2014, Agios initiated four expansion cohorts as part of the ongoing Phase 1 study and expanded its development program with the initiation of a Phase 1/2 study of AG-221 in advanced solid tumors.
AG-221 is part of Agios' global strategic collaboration with Celgene. Under the terms of the collaboration, Celgene has worldwide development and commercialization rights for AG-221. Agios continues to conduct clinical development activities within the AG-221 development program and is eligible to receive up to $120 million in payments on achievement of certain milestones and royalties on net sales.

Disease: acute myeloid leukemia (AML)

Therapeutic area: Cancer - Oncology

Country: Australia, Belgium, Italy, Spain, USA

Trial details:

The IDHENTIFY study is an international, multicenter, open-label, randomized, Phase 3 study designed to compare the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation. (NCT02577406)

Latest news:

• On October 16, 2015, Agios Pharmaceuticals announced the initiation of the AG-221 Phase 3 Study. The IDHENTIFY study is a Phase 3, international, multi-center, open-label, randomized clinical trial designed to compare the efficacy and safety of AG-221 versus conventional care regimens in patients 60 years or older with IDH2 mutant-positive AML that is refractory to or relapsed after second- or third-line therapy.