Daiichi Sankyo has reported positive data from a Phase III clinical trial, where its quizartinib plus standard induction and consolidation chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival (OS) in adults with FLT3-ITD positive acute myeloid leukaemia (AML).

Quizartinib is an oral, highly potent and selective type II FLT3 inhibitor.

Named QuANTUM-First, the double-blind, randomised, placebo-controlled international trial analysed quizartinib plus standard induction and consolidation chemotherapy and then as continued monotherapy in adults aged 18 to 75 years with newly diagnosed FLT3-ITD positive AML. 

Subjects were categorised into 1:1 ratio to receive quizartinib or placebo, along with anthracycline- and cytarabine-based regimens. 

According to the findings, quizartinib plus chemotherapy and subsequently continued as a monotherapy, offered a 22.4% decline in mortality risk versus standard chemotherapy alone in trial subjects.

Median OS was 31.9 months for subjects in the quizartinib arm versus 15.1 months for those who received chemotherapy alone, following a median follow-up of 39.2 months.

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Quizartinib combination treatment’s safety was found to be generally manageable without any new safety signals detected.

The initial event-free survival assessment did not demonstrate a statistically significant difference between the two trial arms.

The composite complete remission rate was found to be greater for subjects who received quizartinib versus chemotherapy alone while the complete remission rates were consistent between the two trial arms.

Daiichi Sankyo R&D global head Ken Takeshita said: “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. 

“Adding targeted treatment with quizartinib, a potent and selective FLT3 inhibitor, to standard chemotherapy resulted in a doubling of median overall survival in patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia compared to standard chemotherapy alone.”

In January this year, the company initiated a Phase I/II/III trial of a booster dose of Covid-19 vaccine, DS-5670, in Japan.