All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your AML Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.

The AML Hub is an independent medical education platform, sponsored by Daiichi Sankyo, Jazz Pharmaceuticals, Kura Oncology, Roche and Syndax and has been supported through a grant from Bristol Myers Squibb. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.

2018-01-04T12:44:12.000Z

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

Jan 4, 2018
Share:

Bookmark this article

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.

Your opinion matters

HCPs, what is your preferred format for educational content on the AML Hub?
14 votes - 3 days left ...

Newsletter

Subscribe to get the best content related to AML delivered to your inbox