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The trial that gave older AML patients a real treatment: adding venetoclax to azacitidine doubled remission rates and extended survival.
Median OS 14.7 vs 9.6 months (HR 0.66, 95% CI 0.52-0.85); composite CR 66.4% vs 28.3%; CR 36.7% vs 17.9%. Benefit across IDH1/2 (OS HR 0.35) and NPM1 subgroups; less in FLT3-ITD and TP53. Long-term follow-up (2022): 24-month OS 37.5% vs 16.7%. NEJM 2020. Became the global standard for unfit AML and the backbone for triplet trials.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
443 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Venetoclax + azacitidine | 286 | 14.7 months | 0.66 (0.52 to 0.85) | <0.001 | link |
| Placebo + azacitidine | 145 | 9.6 months | ||||
| Complete remissionprimary | Venetoclax + azacitidine | - | 36.7% | - | - | link |
| Placebo + azacitidine | - | 17.9% | ||||
| Composite CR (CR + CRi) | Venetoclax + azacitidine | - | 66.4% | - | - | link |
| Placebo + azacitidine | - | 28.3% |
Shares Courtney D. DiNardo, VIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy, IDH1- and IDH2-mutated acute myeloid leukaemia, Acute myeloid leukaemia in older or unfit patients.
Shares Courtney D. DiNardo, IDH1- and IDH2-mutated acute myeloid leukaemia, Acute myeloid leukaemia in older or unfit patients, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, FLT3-mutated acute myeloid leukaemia, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Secondary and therapy-related acute myeloid leukaemia.
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, Secondary and therapy-related acute myeloid leukaemia, Acute myeloid leukaemia in older or unfit patients, Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome.
Shares Acute myeloid leukaemia in older or unfit patients, BCL-2 inhibitors, Azacitidine, Venetoclax.
Shares Acute myeloid leukaemia in older or unfit patients, BCL-2 inhibitors, Azacitidine, Venetoclax.
Shares BCL-2 inhibitors, Azacitidine, AbbVie (incl. ImmunoGen, Capstan), Venetoclax.
Shares BCL-2 inhibitors, Azacitidine, AbbVie (incl. ImmunoGen, Capstan), Venetoclax.