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Showed a pill beats intensive salvage chemotherapy in relapsed FLT3-mutated AML, with fewer days in hospital.
ADMIRAL, trial NCT02421939 sponsored by Astellas and published in the New England Journal of Medicine in 2019, showed that the FLT3 inhibitor gilteritinib as a single tablet beats intensive salvage chemotherapy in relapsed or refractory FLT3-mutated acute myeloid leukaemia, with fewer days in hospital. It randomised 371 patients, met its primary endpoints of overall survival and complete remission with partial haematological recovery, converted gilteritinib's accelerated approval to full approval and made FLT3 inhibitor monotherapy the standard bridge to transplant at relapse. OnCo links it to acute myeloid leukaemia, FLT3 as a target, gilteritinib, Alexander E. Perl and the ADMIRAL paper. Whether gilteritinib should be combined with venetoclax or chemotherapy at relapse is the open question.
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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Gilteritinib | 247 | 9.3 months | 0.64 (0.49 to 0.83) | <0.001 | link |
| Salvage chemotherapy | 124 | 5.6 months | ||||
| CR/CRhprimary | Gilteritinib | - | 34% | - | - | link |
| Salvage chemotherapy | - | 15.3% |
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Astellas, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Astellas, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, Astellas, Acute myeloid leukaemia, Small-molecule kinase inhibitors.
Shares ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia, Gilteritinib, FLT3, FLT3-mutated acute myeloid leukaemia.
Shares Gilteritinib, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Gilteritinib, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.