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 the MPN Advocates Network.

The MPN 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 MPN Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The MPN 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 MPN Hub cannot guarantee the accuracy of translated content. The MPN 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 MPN Hub is an independent medical education platform, sponsored by AOP Health and GSK, and supported through an educational 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.

2020-06-19T09:48:15.000Z

Long-term safety analyses of momelotinib in patients with myelofibrosis

Jun 19, 2020
Share:

Bookmark this article

Momelotinib is a selective and orally available inhibitor of Janus kinase (JAK) 1, JAK2, and activin A type 1 receptor (ACVR1) that targets key drivers of myelofibrosis. The drug was investigated in two phase III studies, SIMPLIFY-1 and SIMPLIFY-2. In the SIMPLIFY-1 trial, patients with myelofibrosis, who were JAK inhibitor naïve (n = 432), were randomized 1:1 to 24 weeks of momelotinib or ruxolitinib. While in the SIMPLIFY-2 trial, patients with myelofibrosis, previously exposed to ruxolitinib (n = 156), were randomized 2:1 to momelotinib or best available therapy for 24 weeks. All patients from both studies were subsequently allowed to receive momelotinib for an extended period.1

Last year momelotinib has been granted Fast Track designation by the U.S. Food and Drug Administration, for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.1,2

The long-term safety and dose intensity of momelotinib from > 550 patients across the two SIMPLIFY studies and their extended treatment periods were presented during the 25th European Hematology Association (EHA) virtual congress. Overall, > 90 patients continued to receive momelotinib for ≥ 3.5 years.2,3

The long-term safety data demonstrated a continued rapid and sustained increase in hemoglobin with momelotinib therapy, compared with a significant decrease observed in patients receiving ruxolitinib. Momelotinib treatment was also associated with a significant increase in platelet count. The improvements in hemoglobin and platelets were also observed in patients who switched from ruxolitinib.  

In contrast to ruxolitinib, which frequently required dose reductions, in the majority of patients, the initial high dose intensity of momelotinib could be maintained over an extended treatment period. Furthermore, the long-term tolerability of momelotinib was favorable, with no new safety concerns, evidence of cumulative toxicity, or significant rates of high-grade hematological toxicities. 

The authors believe that ‘’momelotinib may be an optimal therapy in myelofibrosis patients, in particular for areas with significant unmet needs such as those experiencing hematological toxicity and disease-related myelosuppression, which are common in this disease.’’

Momelotinib is also being compared with danazol in a phase III MOMENTUM clinical trial (NCT04173494) in patients with symptomatic and anemic myelofibrosis who have been treated previously with a JAK inhibitor.3 

  1. Gupta V, Egyed M, Hus M, et al. Momelotinib dose-intensity is maintained in jaki naïve and previously JAKi treated intermediate/ high risk myelofibrosis patients. Poster presentation #EP1103. 2020 EHA Annual Meeting; Jun, 2020; Virtual.
  2. Harrison C, Andreasson B, Cambier N, et al. Long term safety of momelotinib in JAK inhibitor naïve and previously JAK inhibitor treated intermediate/high risk myelofibrosis patients. Poster presentation #EP1113. 2020 EHA Annual Meeting; Jun, 2020; Virtual.
  3. Sierra Oncology. Sierra announces momelotinib granted FDA fast track designation. http://investor.sierraoncology.com/2019-06-05-Sierra-Announces-Momelotinib-Granted-FDA-Fast-Track-Designation. Published Jun 5, 2019. Accessed Jun 15, 2020.

Your opinion matters

As a result of this content, I commit to reviewing the latest data with luspatercept to guide my treatment of myelofibrosis-associated anemia.
29 votes - 3 days left ...

Newsletter

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