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Acute Myeloid Leukemia: Daiichi Sankyo to Present Data from AML Franchise Including FLT3 Inhibitor Quizartinib at ASH Annual Meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it will present data on investigational compounds in the AML Franchise pipeline of the Daiichi Sankyo Cancer Enterprise at the 60th Annual Meeting of the American Society of Hematology (ASH) from December 1-4 in San Diego.

Final results from the pivotal phase 3 QuANTUM-R study of quizartinib will be presented during an oral presentation, which will include sensitivity analyses of overall survival and event-free survival, key subgroup analyses and exploratory endpoints of response rates, duration of composite complete response rate and transplant rate. Additional poster presentations will include updated phase 1 data on valemetostat (DS-3201), an investigational EZH1/2 dual inhibitor, in patients with relapsed/refractory non-Hodgkin lymphomas, and preclinical research evaluating the combination of quizartinib and milademetan (DS-3032), an investigational MDM2 inhibitor, in FLT3-ITD AML.

“This is an exciting time in the advancement of science to treat patients with AML, and we look forward to presenting additional data from the QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD AML, a difficult-to-treat form of the disease,” said Arnaud Lesegretain, Vice President, Oncology Research and Development and Head, AML Franchise, Daiichi Sankyo. “Our research presented at ASH demonstrates our commitment to developing compounds that may have the potential to represent meaningful treatment advances for patients with cancer.”

Quizartinib is currently under accelerated regulatory review with the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of adult patients with relapsed/refractory FLT3-ITD AML. Submissions in the U.S. and EU remain on track for the second half of fiscal year 2018. In the QuANTUM-R study, the median treatment duration with quizartinib was 4 cyles of 28 days each versus 1 cycle in the salvage chemotherapy arm.

Incidence of treatment-emergent adverse events was comparable between patients who received single agent quizartinib and those who received salvage chemotherapy. The most common adverse drug reactions (>30 percent, any Grade) in patients treated with quizartinib included infections, bleeding, nausea, asthenic conditions, pyrexia, febrile neutropenia and vomiting, and the most common Grade ≥ 3 adverse drug reactions (>20 percent) were infection and febrile neutropenia. The most common laboratory adverse reactions (incidence >50 percent) were decreased white blood cell count, decreased lymphocyte count, decreased hemoglobin, decreased neutrophil count and decreased platelet count.

The safety profile observed in QuANTUM-R appears consistent with that observed at similar doses in the quizartinib clinical development program.

The following data from the pipeline of Daiichi Sankyo Cancer Enterprise will be presented at ASH:

  • Efficacy and Safety of Single-Agent Quizartinib (Q), a Potent and Selective FLT3 Inhibitor
    (FLT3i), in Patients (pts) with FLT3-Internal Tandem Duplication (FLT3-ITD)-Mutated
    Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) Enrolled in the Global, Phase 3,
    Randomized Controlled QuANTUM-R Trial. (Abstract 563; Oral Presentation; Monday, December 3, 2018 at 8:00 AM PST)
  • DS-3201, a Potent EZH1/2 Dual Inhibitor, Demonstrates Antitumor Activity in Non-Hodgkin
    Lymphoma Regardless of EZH2 Mutation. (Abstract 2217; Poster Presentation; Saturday, December 1, 2018 at 6:15 PM – 8:15 PM PST)
  • Combination of FLT3 Inhibitor Quizartinib and MDM2 Inhibitor Milademetan Results in Greater Preclinical Antileukemic Activity in FLT3-ITD Mutant/P53 Wild-type Acute Myeloid Leukemia Models. (Abstract 2720; Poster Presentation; Sunday, December 2, 2018 at 6:00 – 8:00 PM PST)
  • Development of a Novel Next-Generation Sequencing (NGS)-Based Assay for Measurable Residual Disease (MRD) in FLT3-ITD AML and Its Potential Clinical Application in Patients Treated with Chemotherapy Plus FLT3 Inhibitors. (Abstract 1459; Poster Presentation; Saturday, December 1, 2018 at 6:15 PM – 8:15 PM PST)
  • Real-World Differences in Characteristics and Survival of Relapsed AML Patients With and Without Transplant. (Abstract 2297; Poster Presentation; Saturday, December 1, 2018 at 6:15 PM –8:15 PM PST)
  • Characterization of Health Care Resource Utilization Among Commercially Insured Relapsed Acute Myeloid Leukemia Patients in the United States. (Abstract 5860; Online Abstract Publication)

 

Quizartinib, the lead investigational agent in the AML Franchise of the Daiichi Sankyo Cancer Enterprise, is an oral selective FLT3 inhibitor currently in phase 3 development for relapsed/refractory FLT3-ITD AML (QuANTUM-R) in the U.S. and EU; phase 3 development for newly-diagnosed FLT3-ITD AML (QuANTUM-First) in the U.S., EU and Japan; and, phase 2 development for relapsed/refractory FLT3-ITD AML in Japan. Quizartinib has been granted Breakthrough Therapy designation for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, and Fast Track designation for the treatment of relapsed/refractory AML by the U.S. Food and Drug Administration (FDA). Quizartinib also has been granted Orphan Drug designation by both the FDA and the European Commission (EC) for the treatment of AML and by the Japan MHLW for the treatment of FLT3-mutated AML.

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