Positive results from the global pivotal QuANTUMFirst phase 3 trial of Daiichi Sankyo’s quizartinib demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive acute myeloid leukaemia (AML) compared to standard chemotherapy alone.

The data were featured as part of the press programme and presented during the Presidential Symposium (#S100) at the European Haematology Association (#EHA2022) Congress. 

Quizartinib combined with standard induction and consolidation chemotherapy and then continued as a single agent demonstrated a 22.4 per cent reduction in the risk of death compared to standard chemotherapy alone in patients with newly diagnosed FLT3-ITD positive AML. 

“The QuANTUM-First results show that adding quizartinib to standard chemotherapy significantly improved overall survival in patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia,” said Harry P Erba, Instructor, Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke Cancer Institute. 

“We are proud that another one of our medicines has demonstrated a significant survival advantage, as our goal is to leverage innovative science to change the way cancer is treated,” said Ken Takeshita, Global Head, R&D, Daiichi Sankyo. 

The OS improvement with quizartinib was also supported by a sensitivity analysis censoring for the effect of allogenic hematopoietic stem cell transplant.

Quizartinib has received Fast Track Designation from the US Food and Drug Administration for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive, in combination with standard cytarabine and anthracycline induction and cytarabine consolidation. Orphan Drug Designation has been granted to quizartinib for the treatment of AML in Europe, Japan and the US.

Quizartinib is currently approved for use in Japan under the brand name Vanflyta for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan.