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, Johnson & Johnson, Kura Oncology, Roche, Syndax and Thermo Fisher, 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.

2020-07-21T08:53:02.000Z

Expansion of trial of eprenetapopt in combination with venetoclax and azacitidine in patients with TP53-mutated AML

Jul 21, 2020
Share:

Bookmark this article

On July 16, 2020, it was announced that the phase I trial (NCT04214860), evaluating eprenetapopt in combination with venetoclax and azacitidine in patients with TP53 mutations, was expanded and will include the addition of another cohort of patients who will be treated with eprenetapopt in combination with azacitidine as a frontline treatment. The decision to expand was based upon the results from two independent phase Ib/II clinical trials (NCT03588078 and NCT03072043).1

The lead-in safety portion of these studies demonstrated that both treatment regimens, eprenetapopt + venetoclax + azacitidine, and eprenetapopt + azacitidine, were well tolerated, and no dose-limiting toxicities were experienced. The expansion cohort will treat patients with TP53-muted AML with the triplet therapy of eprenetapopt + venetoclax + azacitidine (~ n = 30) and with the doublet therapy of eprenetapopt + azacitidine (~ n = 30) as frontline therapies. Safety and efficacy will be evaluated in both cohorts.1

Eprenetapopt/APR-2461

  • A small molecule that, once converted into the active form, restores wild-type p53 conformation and function, thus reactivating mutant and inactivated p53 protein to induce apoptosis in cancer cells
  • Is in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML)
  • Received Breakthrough Therapy, orphan drug designation, and Fast Track designation from the U.S. Food and Drug Administration (FDA) for MDS
  • Received orphan drug designation from the European Medicines Agency (EMA) for MDS, AML, and ovarian cancer
  • A pivotal phase III trial, evaluating eprenetapopt in combination with azacitidine as a frontline treatment for patients with TP53-mutated MDS, is currently ongoing

NCT042148602–4

  • Phase I trial of eprenetapopt in combination with venetoclax and azacitidine in TP53-mutant myeloid malignancies
  • Doses:
    • Eprenetapopt, 4.5 g/day
    • Venetoclax, 400 mg/day
    • Azacitidine, subcutaneously or intravenously, 75 mg/m2
  • Primary outcomes: Tolerability and incidence of treatment-emergent adverse events

  1. Aprea Therapeutics. Aprea Therapeutics announces expansion of clinical trial evaluating eprenetapopt for the front-line treatment of TP53 mutant acute myeloid leukemia (AML). https://ir.aprea.com/news-releases/news-release-details/aprea-therapeutics-announces-expansion-clinical-trial-evaluating. Published Jul 16, 2020. Accessed Jul 17, 2020.
  2. Clinicaltrials.gov. APR-246 in combination with venetoclax and azacitidine in TP53-mutant myeloid malignancies. https://clinicaltrials.gov/ct2/show/NCT04214860. Updated Mar 19, 2020. Accessed Jul 17, 2020.
  3. Clinicaltrials.gov. Study of the safety and efficacy of APR-246 in combination with azacitidine. https://clinicaltrials.gov/ct2/show/NCT03588078. Updated Jan 30, 2020. Accessed Jul 17, 2020.
  4. Clinicaltrials.gov. Phase 1b/2 safety and efficacy of APR-246 w/azacitidine for tx of TP53 mutant myeloid neoplasms. https://clinicaltrials.gov/ct2/show/NCT03072043. Updated May 27, 2020. Accessed Jul 17, 2020.

Your opinion matters

HCPs, what is your preferred format for educational content on the AML Hub?
28 votes - 48 days left ...

Newsletter

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