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.

2019-01-04T12:38:10.000Z

ASH 2018 | Phase II RADIUS study of standard of care with or without midostaurin after allogeneic SCT in patients with FLT3-ITD mutated acute myeloid leukemia

Jan 4, 2019
Share:

Bookmark this article

The primary results of the phase II RADIUS study (NCT01883362) were reported at the 60th American Society of Hematology Annual Meeting & Exposition by Richard Thomas T. Maziarz from OR Health Sciences University, Portland, US. The phase II, randomized, exploratory RADIUS study is assessing whether the addition of midostaurin, a multi-targeted tyrosine kinase inhibitor, to standard of care (SOC) after allogeneic stem cell transplantation (alloSCT) can reduce the risk of relapse in patients with fms-like tyrosine kinase 3-internal tandem duplication positive (FLT3-ITD+) acute myeloid leukemia (AML).

In this study, 60 patients with FLT3-ITD+ AML who underwent myeloablative alloSCT in first complete remission (CR1) were randomized to receive SOC with (n = 30; median age = 48 years) or without (n = 30; median age = 56 years) midostaurin (50 mg twice daily, continuous 28 day cycles). Treatment began 28–60 days after alloSCT. The median duration of exposure in the midostaurin arm was 10.5 months (range: 1.2–11.5 months) and the median dose intensity was 93 mg/day (range, 25–100 mg/day).

The primary objective of the study was relapse-free survival (RFS) at 18 months post-alloSCT. Key secondary objectives include safety and RFS at 24 months post-alloSCT.

Key findings:

  • RFS at 18 months post-alloSCT in the midostaurin plus SOC and SOC alone arm, respectively: 89% (95% CI, 69–96) vs 76% (95% CI, 54–88), HR = 0.46 (95% CI, 0.12–1.86), P = 0.2655
  • RFS at 24 months post-alloSCT in the midostaurin plus SOC and SOC alone arm, respectively: 85% (95% CI, 64–94) vs 76% (95% CI, 54–88), HR = 0.60 (95% CI, 0.17–2.14), P = 0.4297
  • The most common any-grade adverse event (AE) in the SOC and midostaurin plus SOC arm was vomiting: 23% vs 73%, respectively 
  • The most common any-grade AEs with midostaurin were low-grade gastrointestinal events
  • Rates of graft-versus-host disease (GvHD) were similar between SOC and midostaurin plus SOC arms
    • Acute GvHD: 70% vs 73%
    • Chronic GvHD: 47% vs 37%

The speaker stated that maintenance therapy with midostaurin may contribute to a 54% relative reduction in the risk of relapse versus SOC alone. In addition, midostaurin was well tolerated and did not increase the rates or severity of GvHD.

In an interview with the AGP, Richard Maziarz concluded that the midostaurin monotherapy can be safely administered in the post-transplant setting and may improve outcomes in patients who undergo alloSCT in CR1.

Expert Opinion

  1. Maziarz R.T.T. et al. Radius: a phase 2 randomized trial investigating standard of care ± midostaurin after allogeneic stem cell transplant in FLT3-ITD–mutated AML. 2018 Dec 3; Oral Abstract #66260th ASH Annual Meeting and Exposition, San Diego, CA.

Your opinion matters

HCPs, what is your preferred format for educational content on the AML Hub?
15 votes - 80 days left ...

Newsletter

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