QuANTUM-R phase III study of single agent quizartinib met its primary endpoint in relapsed/refractory acute myeloid leukemia .- Daiichi Sankyo.
Daiichi Sankyo Company, Limited announces that 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.
“Single agent quizartinib is the first FLT3 inhibitor to show a significant improvement in overall survival compared to cytotoxic chemotherapy in a randomized phase 3 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, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo.
QuANTUM-R is a pivotal, global, phase III, open-label randomized study that enrolled 367 patients with FLT3-ITD-mutated AML who were refractory to or in relapse (with duration of remission of six months or less) following standard first-line AML therapy with or without HSCT. Patients were randomized in a 2:1 ratio to receive either single agent oral quizartinib or salvage chemotherapy. The primary objective of the study was to determine whether single agent quizartinib prolonged overall survival compared to salvage chemotherapy. Daiichi Sankyo intends to initiate regulatory submissions worldwide for quizartinib on the basis of the QuANTUM-R results. The topline results of QuANTUM-R will be presented at an upcoming scientific conference.
Comment: Rydapt (midostaurin) is a Novartis’ drug which inhibits FLT3 but also other kinases— and is currently approved for use alongside chemotherapy in newly-diagnosed AML patients. Another targeted therapy is Celgene’s Idhifa (enasidenib) that targets AML patients with IDH mutations.
Comment: Daiichi Sankyo is carrying out a phase III trial in previously-untreated patients called QuANTUM-First that is due to report in 2020.
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