Daiichi's AML candidate leads to median OS of 6.2 months

Daiichi Sankyo Co. Ltd. (Tokyo:4568) reported additional data from the Phase III QuANTUM-R trial to treat relapsed or refractory acute myelogenous leukemia (AML) showing that oral quizartinib led to median overall survival (OS), the primary endpoint, of 6.2 months vs. 4.7 months for salvage chemotherapy (HR=0.76, 95% CI: 0.58, 0.98, p=0.0177). The estimated survival probability at one year was 27% for quizartinib vs. 20% for salvage chemotherapy. Data were presented at the European Hematology Association meeting in Stockholm.

In May, Daiichi reported that quizartinib met the primary endpoint. At the time, the company said it planned to submit worldwide regulatory applications for the FMS-like tyrosine kinase 3 (FLT3; CD135) inhibitor in the indication, but declined to disclose a timeline (see "Daiichi Planning Regulatory Submissions for AML Candidate")...