Otsuka's guadecitabine misses in Phase III for first-line AML

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and its Astex Pharmaceuticals Inc. subsidiary said first-line treatment with guadecitabine (formerly SGI-110) missed the co-primary endpoints in the Phase III ASTRAL-1 trial to treat previously untreated acute myelogenous leukemia.

The companies plan to continue evaluating guadecitabine in the Phase III ASTRAL-2 trial for relapsed or refractory AML following intensive chemotherapy and the Phase III ASTRAL-3 trial to treat myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) after failure of azacitidine, decitabine or both...