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Otsuka's Guadecitabine Fails in ASTRAL-1 But AML Studies Continue

 
• By John Davis

Otsuka's guadecitabine has missed co-primary endpoints in older treatment-naïve AML patients but it continues to be evaluated in relapsed and refractory patients, in a therapeutic area undergoing considerable innovation.  

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Drug development can be an up and down journey. • Source: Shutterstock

Astex Pharmaceuticals Inc./Otsuka Holdings Co. Ltd.'s potential next-generation leukemia therapy, guadecitabine, has missed its co-primary endpoints in the Phase III ASTRAL-1 study in older patients with previously untreated acute myeloid leukemia (AML).

Top-line data from the study, comparing guadecitabine with the physician's choice of therapy - azacitidine (Celgene Corp./Nippon Shinyaku Co. Ltd.'s Vidaza), decitabine (Otsuka/Johnson & Johnson's Dacogen) or...

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