Daiichi Sankyo’s FLT3 Inhibitor Vanflyta Plus Chemotherapy Significantly Extends Survival in First-Line Treatment of FLT3-ITD+ AML

The results showed that the QuANTUM-First trial met its primary endpoint:Compared to patients receiving only standard treatment, patients receiving Vanflyta + standard induction and consolidation chemotherapy, followed by continued treatment with Vanflyta monotherapy, showed a statistically significant and clinically meaningful improvement in overall survival (OS).In the study, the safety of Vanflyta was manageable and consistent with the known safety profile of the drug.

AML is one of the most common types of leukemia in adults, accounting for about one-third of all cases. The 5-year survival rate for AML is approximately 29%, and the prognosis for patients with FLT3-ITD positive AML is particularly unfavorable, including an increased risk of relapse and a shorter overall survival. For the majority of AML patients, the need for improved survival remains high.

Data from the QuANTUM-First trial will be presented at an upcoming medical conference.Meeting, and will be shared with regulatory authorities. Ken Takeshita, Head of R&D at Daiichi Sankyo, stated: "The results of the Phase 3 QuANTUM-First trial demonstrate that adding the potent and selective FLT3 inhibitor Vanflyta to chemotherapy can significantly extend...DiagnosisOverall survival in FLT3-ITD positive AML patients. We look forward to sharing the QuANTUM-First data with the hematology community and will engage in discussions with global regulatory authorities."

The active pharmaceutical ingredient quizartinib in Vanflyta belongs to the second-generation FLT3 inhibitors. This drug is an oral small-molecule receptor tyrosine kinase inhibitor that selectively targets and inhibits FLT3.In the United States, quizartinib has been approvedFDAGranted Breakthrough Therapy Designation (BTD) for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, and Fast Track Designation (FTD) for the treatment of relapsed/refractory AML. Additionally, quizartinib has been granted Orphan Drug Designation (ODD) for the treatment of AML in the United States and the European Union, and ODD for the treatment of FLT3-mutated AML in Japan.

Acute Myeloid Leukemia (AML) is an aggressive blood and bone marrow cancer that causes dysfunctional cancerous white blood cells to proliferate and accumulate uncontrollably in the patient's body, affecting the normal production of blood cells. FLT3 (FMS-like tyrosine kinase 3) is typically expressed by hematopoieticStem CellsThe transmembrane receptor tyrosine kinase protein. FLT3 promotes cell survival, growth, and differentiation through various signaling pathways, playing a crucial role in cell development.

FLT3 gene mutations can drive oncogenic signaling and are one of the most common genetic abnormalities in AML, occurring in approximately 30% of AML patients. Among these, FLT3-ITD is the most common FLT3 mutation, affecting about 25% of AML patients. FLT3-ITD is a driver mutation associated with high leukemia burden, poor prognosis, and significant impact on disease management in AML patients.Compared with AML patients without FLT3-ITD mutations, FLT3-ITD AML patients have a poorer overall prognosis, including increased relapse rates, increased risk of death after relapse, and hematopoieticStem CellsThe possibility of recurrence after transplantation is higher.

June 2019,Vanflyta Receives World's First Regulatory Approval in Japan for the Treatment of Adult Patients with Relapsed/Refractory FLT3-ITD Positive AML.Currently, Vanflyta has not been approved in other countries and regions. (Bioon.com)

Source of the original text:Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed FLT3-ITD Positive AML