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▎The content team editor of WuXi AppTec recently announced that Daiichi Sankyo (Daiichi Sankyo) announced that the oral FLT3 inhibitor quizartinib will be combined with standard chemotherapy for the first-line treatment of 3 patients with acute myeloid leukemia (AML) with FLT3-ITD mutations.
The primary endpoint was reached in the phase clinical trial
.
Compared with standard treatment controls, the overall survival (OS) of patients who received quizartinib combined with standard induction and consolidation chemotherapy and then continued to receive quizartinib monotherapy showed a significant improvement in overall survival (OS)
.
In addition, the drug showed good safety characteristics, and no new safety signals were found
.
AML is one of the most common leukemias in adults, accounting for about one-third of all cases
.
As a rapidly progressing blood and bone marrow cancer, cancerous white blood cells in AML patients grow rapidly.
Not only can they not perform normal functions, but they also affect the production of normal blood cells
.
The 5-year survival rate of AML patients is the lowest among all leukemia types, and the prognosis of FLT3-ITD mutation patients is particularly poor
.
FLT3 is a transmembrane receptor tyrosine kinase protein, usually expressed by hematopoietic stem cells.
It promotes cell survival, growth and differentiation through various signaling pathways, and plays an important role in cell development
.
FLT3 gene mutation is the most common gene mutation in AML patients
.
FLT3-ITD is the most common FLT3 gene mutation, occurring in approximately one-quarter of AML patients
.
Quizartinib is an oral FLT3 inhibitor
.
It has obtained breakthrough therapy designation and fast-track qualifications granted by the FDA, and has been approved in Japan
.
▲The molecular structure of Quizartinib (picture source: Ed (Edgar181), Public domain, via Wikimedia Commons) This randomized, double-blind, placebo-controlled, multicenter phase 3 trial enrolled 539 AML patients with FLT3-ITD mutations (18-75 years old)
.
Patients were randomized to receive quizartinib or placebo at a ratio of 1:1, combined with anthracyclines and cytarabine (standard induction and consolidation chemotherapy regimens)
.
Eligible patients will continue to use quizartinib monotherapy or placebo for up to 36 cycles
.
The primary endpoint of the trial is OS, and secondary endpoints include event-free survival (EFS), complete remission (CR), safety, and pharmacokinetics
.
"The results of the phase 3 clinical trial show that the addition of a potent and selective FLT3 inhibitor quizartinib to chemotherapy regimens can significantly extend the overall survival of patients with FLT3-ITD mutant AML
.
" Ken Takeshita, Global Head of Research and Development, Daiichi Sankyo The doctor said, “We look forward to sharing trial data with the hematology community and will discuss with global regulatory agencies
.
"Reference: [1] Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed FLT3-ITD Positive AML.
Retrieved November 19, 2021, from https:// home/20211118006328/en/Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The views in the article do not represent WuXi AppTec's position, nor does it mean that WuXi AppTec supports or opposes the article.
Viewpoint
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
The primary endpoint was reached in the phase clinical trial
.
Compared with standard treatment controls, the overall survival (OS) of patients who received quizartinib combined with standard induction and consolidation chemotherapy and then continued to receive quizartinib monotherapy showed a significant improvement in overall survival (OS)
.
In addition, the drug showed good safety characteristics, and no new safety signals were found
.
AML is one of the most common leukemias in adults, accounting for about one-third of all cases
.
As a rapidly progressing blood and bone marrow cancer, cancerous white blood cells in AML patients grow rapidly.
Not only can they not perform normal functions, but they also affect the production of normal blood cells
.
The 5-year survival rate of AML patients is the lowest among all leukemia types, and the prognosis of FLT3-ITD mutation patients is particularly poor
.
FLT3 is a transmembrane receptor tyrosine kinase protein, usually expressed by hematopoietic stem cells.
It promotes cell survival, growth and differentiation through various signaling pathways, and plays an important role in cell development
.
FLT3 gene mutation is the most common gene mutation in AML patients
.
FLT3-ITD is the most common FLT3 gene mutation, occurring in approximately one-quarter of AML patients
.
Quizartinib is an oral FLT3 inhibitor
.
It has obtained breakthrough therapy designation and fast-track qualifications granted by the FDA, and has been approved in Japan
.
▲The molecular structure of Quizartinib (picture source: Ed (Edgar181), Public domain, via Wikimedia Commons) This randomized, double-blind, placebo-controlled, multicenter phase 3 trial enrolled 539 AML patients with FLT3-ITD mutations (18-75 years old)
.
Patients were randomized to receive quizartinib or placebo at a ratio of 1:1, combined with anthracyclines and cytarabine (standard induction and consolidation chemotherapy regimens)
.
Eligible patients will continue to use quizartinib monotherapy or placebo for up to 36 cycles
.
The primary endpoint of the trial is OS, and secondary endpoints include event-free survival (EFS), complete remission (CR), safety, and pharmacokinetics
.
"The results of the phase 3 clinical trial show that the addition of a potent and selective FLT3 inhibitor quizartinib to chemotherapy regimens can significantly extend the overall survival of patients with FLT3-ITD mutant AML
.
" Ken Takeshita, Global Head of Research and Development, Daiichi Sankyo The doctor said, “We look forward to sharing trial data with the hematology community and will discuss with global regulatory agencies
.
"Reference: [1] Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed FLT3-ITD Positive AML.
Retrieved November 19, 2021, from https:// home/20211118006328/en/Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The views in the article do not represent WuXi AppTec's position, nor does it mean that WuXi AppTec supports or opposes the article.
Viewpoint
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.