This study, part of the company’s broad oncology development program, will evaluate the safety, tolerability and initial response rates of MLN518 in combination with cytarabine and daunorubicin, the standard induction chemotherapy in front-line acute myelogenous leukemia (AML).
Previous results from a single-agent phase I/II study of MLN518, presented at the annual meeting of the American Society of Hematology 2004, established a well- tolerated dose along with strong preliminary antileukemic activity.
MLN518 is a novel, oral, small molecule designed to inhibit type III receptor tyrosine kinases, including FLT3, PDGFR and c-KIT. Tyrosine kinases are enzymes involved in several cellular processes and are known to be activated in cancer cells to drive tumor growth.
AML patients with FLT3 mutations experience earlier disease relapse and shorter survival rates compared to patients without these mutations. Approximately 25 to 30 percent of all adult AML patients have a mutation of the FLT3 gene. The use of MLN518 to treat AML has been granted fast-track status by the FDA.
“MLN518 has shown promising single-agent activity in relapsed and refractory AML patients whose advanced disease has likely undergone multiple mutations and is therefore more difficult to treat,” said Dr David Schenkein, senior vice president, clinical research, Millennium. “We hope that by administering MLN518 earlier in the treatment paradigm, patients will experience improved outcomes.”