VIALE-A
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.
- Median 14.7 vs 9.6 months with Venetoclax + azacitidine compared with Placebo + azacitidine; about 5.1 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 34 percent lower chance of the event at any given time (hazard ratio 0.66, likely range 0.52 to 0.85).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 36.7 vs 17.9 out of 100 had no sign of cancer on scans or tests with Venetoclax + azacitidine compared with Placebo + azacitidine; 18.8 more per 100.
- Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 66.4 vs 28.3 out of 100 reached this endpoint with Venetoclax + azacitidine compared with Placebo + azacitidine; 38.1 more per 100.
- Roughly one extra person helped for every 3 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Newly diagnosed AML unfit for intensive chemotherapy: venetoclax + azacitidine vs placebo + azacitidine. People in a different situation may not see the same effect.
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.
431 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Venetoclax + azacitidine | 286 | 14.7 months | 0.66 (0.52–0.85) | <0.001 | link |
| Placebo + azacitidine | 145 | 9.6 months | ||||
| Complete remissionprimary | Venetoclax + azacitidine | — | 36.7% | — | — | — |
| Placebo + azacitidine | — | 17.9% | ||||
| Composite CR (CR + CRi) | Venetoclax + azacitidine | — | 66.4% | — | — | — |
| Placebo + azacitidine | — | 28.3% |
Pages like this
not linked directly; found by shared links- ProductDecitabine + cedazuridine (oral)
Shares Shorter venetoclax courses in unfit AML, Venetoclax + hypomethylating agent, Venetoclax, Acute myeloid leukaemia.
- TrialASCERTAIN-V
Shares Venetoclax + hypomethylating agent, Venetoclax, Acute myeloid leukaemia.
- PersonAnthony Letai
Shares Intrinsic apoptosis (BCL-2 family), BCL-2, Venetoclax, Acute myeloid leukaemia.
- TrialCLL14
Shares Tumour lysis syndrome (TLS), BCL-2, Venetoclax, Older and multimorbid patients are excluded and undertreated.
- PairingMenin inhibitor + venetoclax + azacitidine
Shares VIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy, Azacitidine, Venetoclax, Acute myeloid leukaemia.
- Key paperAGILE: ivosidenib plus azacitidine for newly diagnosed IDH1-mutated AML in patients unfit for intensive chemotherapy
Shares VIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy, Azacitidine, Venetoclax, Acute myeloid leukaemia.
- ProductSonrotoclax
Shares Tumour lysis syndrome (TLS), Intrinsic apoptosis (BCL-2 family), BCL-2, Venetoclax.
- TechnologyBH3 profiling (functional apoptosis testing)
Shares Intrinsic apoptosis (BCL-2 family), BCL-2, Venetoclax, Acute myeloid leukaemia.