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.
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 moreThe 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.
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.
Bookmark this article
On February 28, 2020, it was announced that the VIALE-C trial, comparing venetoclax plus low dose cytarabine (LDAC) to placebo plus LDAC, failed to meet the primary endpoint of significant improvement in overall survival (OS) in patients with treatment-naïve acute myeloid leukemia (AML).1 On the same date, results from the primary analysis were published on ClinicalTrials.gov.2
In November 2018, the U.S. Food & Drug Administration (FDA) granted accelerated approval to venetoclax in combination with azacitidine, decitabine, or LDAC for patients with newly diagnosed AML who were ineligible for intensive induction chemotherapy. The approval for venetoclax plus LDAC was based on promising results reported from a phase I/II trial (NCT02287233), previously reported by the AML Hub.3 The FDA approved the combination but required that the clinical benefit was be verified in a confirmatory trial — VIALE-C.4 No comment has been made from the FDA in light of the announcement and the indications for venetoclax currently remain unchanged.1
Given as venetoclax + LDAC vs placebo + LDAC throughout
In the founding phase I/II trial, venetoclax plus LDAC led to a median OS of 10.1 months (95% CI, 5.7–14.2) with a median duration of remission for patients in CR/CRi of 8.1 months (95% CI, 5.3–14.9). The authors of the phase I/II study concluded that the combination was tolerable and induced high remission rates.4 However, in this confirmatory phase III study, median OS with venetoclax plus LDAC was 7.2 months compared to 4.1 months with LDAC alone. This represented a 25% reduction in the risk of death compared to LDAC alone, which was not statistically significant.1
The results from this study are expected to be presented at an upcoming medical congress and published in full in due course.
Your opinion matters
Subscribe to get the best content related to AML delivered to your inbox