Investigators announced positive topline results for the phase 3 QuANTUM-First trial, assessing the use of quizartinib plus chemotherapy for adult patients with newly diagnosed FLT3-ITD–positive acute myeloid leukemia.
The combination of quizartinib and chemotherapy yielded a superior overall survival (OS) vs chemotherapy alone in adult patients with newly diagnosed FLT3-ITD–positive acute myeloid leukemia (AML), according to positive topline findings from the pivotal phase 3 QuANTUM-First trial (NCT02668653).1
Quizartinib combined with standard induction and consolidation chemotherapy followed by quizartinib monotherapy resulted in a statistically significant and clinically meaningful improvement in OS, meeting the study's primary end point. Moreover, the agent's safety profile proved to be manageable and was consistent with what has been previously observed.
Findings from the trial will be presented at an upcoming medical meeting.
“The results of the phase 3 QuANTUM-First trial showed that adding quizartinib, a potent and selective FLT3 inhibitor, to chemotherapy significantly prolonged overall survival in patients with newly diagnosed FLT3-ITD positive AML,” Ken Takeshita, MD, global head of R&D at Daiichi Sankyo, said in a press release.2 “We look forward to sharing the QuANTUM-First data with the hematology community and will initiate discussions with global regulatory authorities.”
The double blind, placebo controlled, multicenter global trial assessed quizartinib, an oral, highly potent and selective type II FLT3 inhibitor, combined with chemotherapy in a population of adult patients between the ages of 18 and 75 years. Patients who enrolled on the study (n = 539) were randomized 1:1 to received either quizartinib and chemotherapy or placebo plus standard anthracycline- and cytarabine-based induction and consolidation chemotherapy. Patients were treated with either regimen for up to 36 cycles. Those who had undergone allogenic hematopoietic stem cell transplant were eligible for the trial.
Key secondary end points included event-free survival, post-induction rates of complete remission (CR) and composite CR, and the percentage of those who achieved a CR with minimal residual disease negativity.
In June 2019, the FDA issued a complete response letter to drug developer Daiichi Sankyo regarding a new drug application for quizartinib for adult patients with relapsed/refractory FLT3-ITD–positive AML.