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Daiichi scores in PhIII study of AML drug, beating chemo and building its case for worldwide approvals

An AML drug picked up by Daiichi Sankyo in its Ambit buyout has outshone chemotherapy in a late-stage trial, setting up the Japanese drugmaker to file for worldwide approvals.

Antoine Yver

The drug, called quizartinib, was tested in a Phase III study against relapsed or refractory acute myeloid leukemia (blood and bone marrow cancer) — particularly in patients who have the FLT3-ITD mutation. This dangerous (but fairly common) mutation affects one in four AML patients, giving them a worse overall prognosis, including more relapses and an increased risk of death following relapse. There are no approved treatments.

The therapy met its primary endpoint of prolonging overall survival compared to salvage chemotherapy in patients with the FLT3-ITD mutation after first-line treatment. Daiichi didn’t share any data in its press release, but said results would be presented at an upcoming scientific conference.

“Single agent quizartinib is the first FLT3 inhibitor to show a significant improvement in overall survival compared to cytotoxic chemotherapy in a randomized Phase III study of patients with relapsed/refractory AML with FLT3-ITD mutations, a very aggressive form of the disease with limited treatment options,” said Antoine Yver, executive vice president and global head of Daiichi Sankyo’s oncology R&D, in a statement. ” We look forward to working with regulatory authorities worldwide to potentially bring quizartinib to patients as quickly as possible.”

The company said it will use the data to support its other ongoing Phase III trial of the drug. That trial is called QuANTUM-First, and it’s evaluating quizartinib in combination with induction and consolidation chemotherapy as well as a maintenance therapy.

Picked up in the $410 million buyout of San Diego-based Ambit Biosciences in 2014, quizartinib has been granted fast track designation by the FDA, as well as orphan drug designation by the FDA and EMA. The company said these recent Phase III results will form the basis of regulatory submissions for quizartinib worldwide.


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