Quizartinib meets Phase III goals

The pivotal QuANTUM-R Phase III study of single agent quizartinib met its primary endpoint of significantly prolonging overall survival compared to salvage chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations after first-line treatment with or without hematopoietic stem cell transplantation (HSCT).

Safety appears consistent with that observed at similar doses in the quizartinib program, said the drug’s developer, Japanese pharma major Daiichi Sankyo (TYO: 4568), which acquired quizartinib originator, USA-based Ambit Biosciences in a $410 million deal in 2016.

“Single agent quizartinib is the first FLT3 inhibitor to show a significant improvement in overall survival compared to cytotoxic chemotherapy in a randomized Phase III study of patients with relapsed/refractory AML with FLT3-ITD mutations, a very aggressive form of the disease with limited treatment options,” said Antoine Yver, executive vice president and global head, oncology R&D at Daiichi Sankyo