The QuANTUM-First phase 3 trial studying the safety and efficacy of quizartinib for newly diagnosed patients with FLT3-ITD positive acute myeloid leukemia showed superior overall survival when compared to standard of care chemotherapy alone, according to a press release.

Quizartinib is a highly potent selective type II FLT3 inhibitor.

The QuANTUM-First trial was a randomized, double-blind, placebo-controlled, multi-center global phase 3 study that evaluated quizartinib in combination with standard induction and consolidation chemotherapy followed by quizartinib as monotherapy. Patients ages 18-75 with newly diagnosed FLT3-ITD positive acute myeloid leukemia were eligible for this study as well as those who had previously undergone an allogeneic hematopoietic stem cell transplant.

Patients were randomized 1:1 to receive either quizartinib or placebo in combination with standard anthracycline and cytarabine-based induction and consolidation chemotherapy regimens. Quizartinib monotherapy or placebo was then continued for up to 36 cycles.

The primary study endpoint was overall survival, which was met. Secondary endpoints were event-free survival, post-induction rates of complete remission, and composite complete remission.

Quizartinib is currently approved for use in Japan and is still considered an investigational medicine in all other countries. Phase 1/2 clinical trials for quizartinib are still underway in Europe and North America.