Otsuka considers guadecitabine program after new failure

15 October 2020

Japanese drugmaker Otsuka (TYO: 4578) and its member company Astex Pharmaceuticals have announced top-line results of the ASTRAL-2 and ASTRAL-3 clinical studies.

These trials evaluated the efficacy and safety of guadecitabine (SGI-110) in adults with previously-treated acute myeloid leukemia (AML) (ASTRAL-2), and with previously-treated myelodysplastic syndromes or chronic myelomonocytic leukemia (MDS/CMML) (ASTRAL-3), respectively.

Neither study met the primary endpoint of statistically-significant improvement in overall survival (OS) compared with the control arm of physicians’ choice of alternative therapy. Evaluation of the studies’ prospective subgroups and secondary endpoints is ongoing.

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