On October 23, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported the first patient has been dosed in a Phase 1b/2 study evaluating the oral investigational agent, dubermatinib (TP-0903), an AXL kinase inhibitor, in combination with decitabine, in patients 60 years or older with newly diagnosed acute myeloid leukemia (AML) who have TP53 mutations and/or complex karyotype (Press release, Sumitomo Dainippon Pharma, OCT 23, 2020, View Source;lymphoma-societys-beat-aml-master-clinical-trial-in-patients-with-acute-myeloid-leukemia-301158414.html [SID1234568937]). This study is a new arm included in The Leukemia & Lymphoma Society’s (LLS) groundbreaking Beat AML Master Clinical Trial.
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The primary objectives of the study are to determine the safety and maximum tolerated dose of dubermatinib in combination with decitabine and evaluate the composite complete response rate. Secondary objectives of the study include overall survival and proportion of patients transitioning to allogeneic stem cell transplantation.
"Although there have been recent advances in the treatment of AML, for patients with certain types of mutations, prognosis and responsiveness to therapy remain poor. Therefore, dosing the first patient in this study represents an important milestone for patients with AML who have TP53 mutations," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "We’re pleased to be collaborating with The Leukemia & Lymphoma Society and look forward to advancing the study of dubermatinib to learn more about its safety and effectiveness in AML."
AML is one of the deadliest blood cancers and the second most diagnosed type of leukemia in the U.S.1 The Beat AML Master Clinical Trial aims to leverage the expertise of functional genomic technologies and pharmaceutical collaborators, using a personalized medicine approach to accelerate research findings and ultimately improve outcomes for AML patients. Patients with TP53 mutations have few effective treatment options as their response rate to chemotherapy is poor and long-term survival after stem cell transplant is rare.2 The incidence of TP53 mutations in AML has been reported to be between 5 and 19 percent of patients.3-7
The trial is being conducted at several leading cancer centers across the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03013998).
About Dubermatinib (TP-0903)
Dubermatinib is an investigational oral AXL receptor tyrosine kinase (RTK) inhibitor under evaluation in a Phase 1a/b study in patients with advanced solid tumors (NCT02729298) and an ongoing study in collaboration with The Leukemia & Lymphoma Society as part of the Beat AML Master Clinical Trial (NCT03013998). SDP Oncology is exploring parallel clinical development paths for dubermatinib in both solid and hematologic malignancies.
About AXL Kinase
AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers.8 It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion, and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.9