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Frontline Guadecitabine Falls Short in Phase III AML Study

Published: Thursday, Aug 02, 2018

Dr Mohammad Azab

Mohammad Azab, MD

Guadecitabine (SGI-110) did not meet the coprimary endpoints of the phase III ASTRAL-1 study comparing the hypomethylating agent with physician’s choice of standard therapy in treatment-naïve adult patients with AML who are not candidates for intensive induction chemotherapy.

Astex Pharmaceuticals and Otsuka Pharmaceutical announced in a press release that guadecitabine failed to improve complete response rate (P >.04) and overall survival (OS; P >.01)—the 2 primary endpoints of the study—compared with physician’s choice of azacitidine, decitabine, or low-dose cytarabine.

Investigators continue to evaluate secondary outcome measures from the trial, as well as safety. Data from the study will be presented at an upcoming medical conference, according to Astex and Otsuka. Additionally, 2 ongoing trials are examining guadecitabine in the relapsed/refractory setting—ASTRAL-2 (NCT02920008) in AML and ASTRAL-3 (NCT02907359) in myelodysplastic syndromes and chronic myelomonocytic leukemia.

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