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At present, it is not clear whether prophylactic fms-like tyrosine kinase – internal tandem duplication (FLT3-ITD) inhibition with sorafenib, a tyrosine kinase inhibitor, after allogeneic stem cell transplantation (allo-SCT) has any significant impact on relapse and outcomes of patients with FLT3-ITD-positive acute myeloid leukemia (AML) in complete hematological remission (CHR). The phase II SORMAIN trial (EudraCT 2010-018539-16) is a randomized, double-blind, placebo-controlled study, evaluating sorafenib as maintenance therapy after allo-SCT in patients with FLT3-ITD–positive AML. The results of this study were presented by Andreas Burchert from the University of Marburg, Germany, at the 60th American Society of Hematology Annual Meeting & Exposition.
Eighty-three patients (median age = 54.0 years; range, 18.58–75.58) with FLT3-ITD AML who underwent allo-SCT and were in confirmed CHR at the time of screening between day +30 and day +100 post-allo-SCT were included in this study. Patients were randomized to receive sorafenib (n = 43; starting dose: 2 x 1 tbl. [2 x 200 mg] QD, increasing every 14 days to up to 2 x 2 tbl. [2 x 400 mg] QD according to tolerability) or placebo (n = 40) for up to 24 months. The primary and secondary endpoints of the study were relapse-free survival (RFS) and overall survival, respectively.
In an interview with the AML Global Portal (AGP), Andreas Burchert noted that the mature data from the SORMAIN trial demonstrate for the first time, evidence that FLT3 inhibition after allo-SCT is feasible and significantly reduces the risk of relapse and death in patients with FLT3-ITD AML which in turn results in improved survival. He further added that this study has practice-changing implications that will establish a new treatment paradigm for AML.
Editorial theme │ Maintenance therapy for AML
Maintenance therapy has been proven very efficacious at improving long-term patient outcomes and reducing relapse in the acute lymphoblastic leukemia (ALL) setting. Thus, research into the role of...
Andreas Burchert | ASH 2018 | Key highlights of the Sormain trial
Andreas Burchert discusses the study findings of the Sormain trial, which is evaluating sorafenib as maintenance therapy after allogeneic SCT for patients with FLT3-ITD–positive AML
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