FLT3,   General AML

ASH 2017 | Long-term follow-up results from the phase II SORAML trial 

The phase II randomized SORAML trial assessed the efficacy of sorafenib, a multi-targeted kinase inhibitor, in combination with standard chemotherapy in newly diagnosed patients with AML aged ≤60 years. In total, 267 AML patients (median age = 50 years) were randomly assigned to receive standard induction and post-remission chemotherapy with (n = 134) or without sorafenib (n = 133). The primary endpoint of the study was Event Free Survival (EFS).

Findings from that study after a median follow-up of 3 years showed that sorafenib in combination with standard induction and consolidation therapy significantly prolonged the EFS and Relapse Free Survival (RFS) in patients. However, although the Overall Survival (OS) was higher in patients administered sorafenib, it was not statistically significant.1

Christoph Röllig, MD, from University Hospital, Dresden, Germany, presented an updated results from the long-term follow up of outcomes in patients treated in the phase II randomized SORAML trial (NCT00893373) during an oral abstract session at the 59th American Society of Hematology (ASH) Annual Meeting, Atlanta, GA, on Monday 11th December 2017.2

Key findings from the prolonged follow-up of the SORAML trial were1:
  • Median observation time: 78 months
  • Median EFS in the placebo and sorafenib arm: 9 vs 26 months, HR = 0.68, P = 0.01
  • Median RFS in the placebo and sorafenib arm: 23 vs 63 months, HR = 0.64, P = 0.035
  • 4-year OS in the placebo and sorafenib arm: 55% vs 62%, HR = 0.819, P = 0.282
  • Patients in the sorafenib arm had an increased risk of relapse than patients in the placebo arm: HR = 2.03, P = 0.078
  • Median OS from relapse in the placebo and sorafenib arm: 27 vs 10 months, HR = 1.67, P = 0.103

The speaker concluded that, the long-term follow up analysis of this SORAML trial “confirms significant prolongation of EFS by addition of sorafenib to standard chemotherapy” in newly diagnosed AML patients irrespective of their FLT3 mutation status.

Primary sorafenib led to a better OS compared to placebo, albeit not significantly, which the speaker concluded is probably a result of the fact that this “phase II trial was not adequately powered to detect OS differences”. 

  1. Röllig C. et al. Sorafenib Versus Placebo in Addition to Standard Therapy in Younger Patients with Newly Diagnosed Acute Myeloid Leukemia: Results from 267 Patients Treated in the Randomized Placebo-Controlled SAL-Soraml Trial. Blood. 2014; 124:6.
  2. Röllig C. et al. The Addition of Sorafenib to Standard AML Treatment Results in a Substantial Reduction in Relapse Risk and Improved Survival. Updated Results from Long-Term Follow-up of the Randomized-Controlled Soraml Trial. Oral Abstract #721: 59th ASH Annual Meeting and Exposition, Atlanta, GA.
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