AGILE
In IDH1-mutated AML, adding ivosidenib to azacitidine tripled survival, one of the largest effects ever seen in a randomised AML trial.
Event-free survival HR 0.33 (95% CI 0.16-0.69); median OS 24.0 vs 7.9 months (HR 0.44, 95% CI 0.27-0.73); CR 47% vs 15%. Stopped early for benefit. NEJM 2022. Whether ivosidenib-azacitidine or venetoclax-azacitidine (which also works well in IDH-mutant AML) should be first line remains debated; triplets are being tested.
- The treated group had about 67 percent lower chance of the event at any given time (hazard ratio 0.33).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- 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.
- Median 24 vs 7.9 months with Ivosidenib + azacitidine compared with Placebo + azacitidine; about 16.1 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 56 percent lower chance of the event at any given time (hazard ratio 0.44, likely range 0.27 to 0.73).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 47 vs 15 out of 100 had no sign of cancer on scans or tests with Ivosidenib + azacitidine compared with Placebo + azacitidine; 32 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 IDH1-mutated AML unfit for intensive chemotherapy: ivosidenib + azacitidine vs placebo + azacitidine. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (IDH1); the result should not be assumed for people whose cancer does not have it.
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.
146 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | Ivosidenib + azacitidine | 72 | — | 0.33 (0.16–0.69) | 0.002 | link |
| Placebo + azacitidine | 74 | — | ||||
| Overall survival (median) | Ivosidenib + azacitidine | — | 24 months | 0.44 (0.27–0.73) | — | — |
| Placebo + azacitidine | — | 7.9 months | ||||
| Complete remission | Ivosidenib + azacitidine | — | 47% | — | — | — |
| Placebo + azacitidine | — | 15% |
Pages like this
not linked directly; found by shared links- TrialClarIDHy
Shares Ivosidenib, IDH1 / IDH2.
- ProductEnasidenib
Shares IDH1 / IDH2, Acute myeloid leukaemia.
- PersonStephen B. Baylin
Shares Azacitidine, Acute myeloid leukaemia.
- CompanyServier
Shares AGILE: ivosidenib plus azacitidine for newly diagnosed IDH1-mutated AML in patients unfit for intensive chemotherapy, Ivosidenib, Acute myeloid leukaemia.
- PersonTimothy J. Ley
Shares IDH1 / IDH2, Acute myeloid leukaemia.
- Key paperVIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy
Shares AGILE: ivosidenib plus azacitidine for newly diagnosed IDH1-mutated AML in patients unfit for intensive chemotherapy, Azacitidine, Acute myeloid leukaemia.
- ProductOlutasidenib
Shares IDH1 / IDH2, Acute myeloid leukaemia.
- IdeaShorter venetoclax courses in unfit AML
Shares Azacitidine, Acute myeloid leukaemia.