7 quick thoughts about this important aza-ven #AML trial from #EHA25:
1) Study had specific "ineligible for intensive therapy" criteria, akin to Ferrara et al SIS/GITMO @LeukemiaJnl 2013 & ELN 2017 criteria, which we're seeing more of - positive development given past problems./1
1) Study had specific "ineligible for intensive therapy" criteria, akin to Ferrara et al SIS/GITMO @LeukemiaJnl 2013 & ELN 2017 criteria, which we're seeing more of - positive development given past problems./1
2) HMA/venetoclax turned out to be an appropriate use of the @FDAOncology accelerated approval pathway (November 2018) - but we can only know that in retrospect!
3) Median OS of 14.7 months in combination therapy arm is still pretty crummy, and shows we have more work to do./2
3) Median OS of 14.7 months in combination therapy arm is still pretty crummy, and shows we have more work to do./2
4) OS in azacitidine monotherapy control group of 9.6 months (95% CI 7.4-12.7) benchmarks with AZA-AML-001 trial result (10.4 mos) & with Austrian AGMT study group azacitidine #AML registry data (10.3 mos, 10.8 months for "AZA-AML-001 like" patients)./4
ncbi.nlm.nih.gov/pmc/articles/P…
ncbi.nlm.nih.gov/pmc/articles/P…
5) This is an opportunity for 'functional precision medicine', eg pre-Rx BCL2 sensitivity testing @DrTonyLetai. Such testing works in predicting AML induction outcomes; we don't know yet how cost effective. Coincidentally this was topic of @giuliosfat #EHA25 Plenary II talk./5
6) Compare this with just-published low-dose cytarabine (LDAC) + venetoclax vs LDAC + placebo: OS 8.4 months vs. 4.1 months.
7) No trial is perfect but this one was pretty good, and we need more RCTs and less other stuff.
I don't have COI here. /End
ashpublications.org/blood/article/…
7) No trial is perfect but this one was pretty good, and we need more RCTs and less other stuff.
I don't have COI here. /End
ashpublications.org/blood/article/…
