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The trial that made FLT3 the first targetable mutation in AML: adding midostaurin to chemotherapy tripled median survival.
3,277 patients screened to randomise 717 with FLT3-ITD or TKD mutations. Median OS 74.7 vs 25.6 months (HR 0.78, 95% CI 0.63-0.96, p=0.009); 4-year OS 51.4% vs 44.3%; benefit across ITD allelic ratio and TKD subgroups and irrespective of transplant. NEJM 2017. Established the template of TKI added to intensive induction that QuANTUM-First later refined.
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.
717 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Midostaurin + 7+3 | 360 | 74.7 months | 0.78 (0.63 to 0.96) | 0.009 | link |
| Placebo + 7+3 | 357 | 25.6 months | ||||
| 4-year overall survival | Midostaurin | - | 51.4% | - | - | link |
| Placebo | - | 44.3% |
Shares Richard M. Stone, FLT3 inhibitor + intensive chemotherapy, Cytarabine + anthracycline ('7+3'), FLT3.
Shares Richard M. Stone, FLT3 inhibitor + intensive chemotherapy, Cytarabine + anthracycline ('7+3'), Midostaurin.
Shares FLT3-ITD allelic ratio, Midostaurin, FLT3, FLT3-mutated acute myeloid leukaemia.
Shares Midostaurin, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Midostaurin, FLT3, Acute myeloid leukaemia.
Shares FLT3 inhibitor + intensive chemotherapy, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia, Small-molecule kinase inhibitors.
Shares Midostaurin, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.