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Acute Myeloid Leukemia (AML) Franchise main content

Acute Myeloid Leukemia (AML) Franchise

Our AML Franchise is looking to change the standard of care for patients with acute myeloid leukemia (AML), a fast-growing form of leukemia that has the lowest 5-year survival rate of all leukemias with little change in the treatment of AML for the past 30 years.     

Molecular subtyping (classifying tumors into genetically distinct categories) is creating new opportunities to develop targeted AML treatments. Among seven emerging classes of targets to potentially treat AML, Daiichi Sankyo Cancer Enterprise is developing five therapies that target five different mechanisms across three of these classes. These include:

  • Growth factor receptor inhibition with quizartinib, a FLT3 inhibitor in phase 3 clinical development
  • Transcriptional deregulation with DS-3032, an MDM2 inhibitor in phase 1 development
  • Epigenetic regulation with DS-3201, an EZH1/EZH2 inhibitor in phase 1 development, PLX51107, a BRD4 inhibitor in phase 1 development, and DS-1001, an IDH1 inhibitor in preclinical development

Source: Adapted from: Dohner-H et al., NEJM 2015; 373:1136-1152, Thol-F et al., Blood 2015; 126:319-327, Khan et al., Clin Can Res, 2012; Ramos-N, et al., J. Clin. Med. 2015; 4:665-695, Isidori-A et al., Can Res Frontiers 2016; 2:226-251

Pursuing combinations with these five investigational compounds will enable us to potentially expedite development to reach patients sooner, as well as leverage scientific findings to determine appropriate treatment pathways that may help address treatment resistance in AML.

These compounds are investigational agents and are not approved by the FDA or other regulatory agencies worldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under investigation. There is no guarantee that these compounds will become commercially available in indications under investigation.

Acute Myeloid Leukemia (AML) Franchise

Quizartinib

FLT3 Inhibitor

Quizartinib is an investigational oral FLT3 inhibitor currently in phase 3 development for newly-diagnosed and relapsed /refractory FLT3-ITD-mutated acute myeloid leukemia (AML). Quizartinib has been granted Orphan Drug Designation by the FDA and EMA for the treatment of AML. Quizartinib also has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory AML.

Two phase 3 studies of quizartinib are currently underway:

QuANTUM-First: This study is evaluating quizartinib in combination with induction and consolidation chemotherapy as well as a maintenance therapy for newly-diagnosed patients with FLT3-ITD-mutated AML. For more information about the QuANTUM-First study:

QuANTUM-R: This study is evaluating quizartinib versus salvage chemotherapy in patients with refractory or relapsed FLT3-ITD-mutated AML.  For more information about the QUANTUM-R study:

A phase 2 study is also ongoing in Japan in patients with relapsed/refractory FLT3-ITD mutated AML. For more information about this study:

DS-3032

MDM2 Inhibitor

DS-3032 is an investigational oral selective MDM2 inhibitor currently being evaluated in three phase 1 clinical trials for solid and hematological malignancies.

Three phase 1 studies of DS-3032 are currently underway:

Hematological Malignancies: A phase 1 study evaluating DS-3032 in several hematological malignancies including refractory/relapsed acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML) in blast phase and myelodysplastic syndrome (MDS). For more information about this study, visit ClinicalTrials.gov.

Solid Tumors and Lymphomas: A phase 1 study evaluating DS-3032 in advanced solid tumors or lymphomas that have relapsed from or are refractory to standard treatment or for which no standard treatment is available. For more information about this study, visit ClinicalTrials.gov.

Solid Tumors and Lymphomas in Japanese Patients: A phase 1 study evaluating DS-3032 in advanced solid tumors or lymphomas that have relapsed from or are refractory to standard treatment or for which no standard treatment is available. For more information about this study, visit Clinicaltrials.jp.

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