OnCo
trialsTrialPositive

ADMIRAL

Showed a pill beats intensive salvage chemotherapy in relapsed FLT3-mutated AML, with fewer days in hospital.

Median OS 9.3 vs 5.6 months (HR 0.64, 95% CI 0.49-0.83, p<0.001); CR/CRh 34.0% vs 15.3%; 1-year OS 37.1% vs 16.7%. NEJM 2019. Converted gilteritinib's accelerated approval to full approval and made FLT3 inhibitor monotherapy the standard bridge to transplant in relapse.

Setting
Relapsed or refractory FLT3-mutated AML: gilteritinib monotherapy vs salvage chemotherapy
Phase
Phase 3
Sponsor
Astellas
Registry
NCT02421939
Headline result
OS 9.3 vs 5.6 months; HR 0.64.
Reported
2019
Enrolled
371
Replication
Real-world cohorts reproduce ~30% CR/CRh; the LACEWING trial (gilteritinib + azacitidine in unfit frontline) did not improve OS, showing the setting matters.

Outcomes

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In plain words
What these results mean for people, not percentages
371 people took part
Overall survival (median)primarysurvival endpoint
  • Median 9.3 vs 5.6 months with Gilteritinib compared with Salvage chemotherapy; about 3.7 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 36 percent lower chance of the event at any given time (hazard ratio 0.64, likely range 0.49 to 0.83).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
CR/CRhprimarysurrogate endpoint
  • 34 vs 15.3 out of 100 reached this endpoint with Gilteritinib compared with Salvage chemotherapy; 18.7 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.
Be careful
  • These results apply to the people the trial enrolled: Relapsed or refractory FLT3-mutated AML: gilteritinib monotherapy vs salvage chemotherapy. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (FLT3); 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.

371 participants enrolled.

Overall survival (median)primary
HR 0.64 (0.49–0.83) · p <0.001
Gilteritinib
9.3 mo
Salvage chemotherapy
5.6 mo
Source
CR/CRhprimary
Gilteritinib34 of 100
Salvage chemotherapy15.3 of 100
EndpointArmnValueHR (95% CI)pSource
Overall survival (median)primaryGilteritinib2479.3 months0.64 (0.49–0.83)<0.001link
Salvage chemotherapy1245.6 months
CR/CRhprimaryGilteritinib—34%———
Salvage chemotherapy—15.3%
Replication
Real-world cohorts reproduce ~30% CR/CRh; the LACEWING trial (gilteritinib + azacitidine in unfit frontline) did not improve OS, showing the setting matters.

Key papers

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rctNew England Journal of Medicine 2019changed practice
ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia

ADMIRAL showed that a targeted oral drug can beat chemotherapy outright in relapsed AML, and made gilteritinib the standard bridge to transplant for FLT3-mutated relapse. Its success also underpinned FLT3 inhibitor use in first-line combinations. Resistance through FLT3-independent clones and RAS pathway mutations limits durability without transplant.

Connected

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Pages like this

not linked directly; found by shared links

cancers

1
Acute myeloid leukaemia

targets

1
FLT3

drugs

1
ApprovedSmall-molecule kinase inhibitor (FLT3, type I)
Gilteritinib · Xospata

key papers

1
ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia