Roughly doubled median survival in the most aggressive FLT3 subtype by adding a selective FLT3 blocker to chemotherapy, including in patients over 60.
Median OS 31.9 vs 15.1 months (HR 0.776, 95% CI 0.615-0.979, p=0.032) at 39.2 months median follow-up; CR rates similar but relapse-free survival and MRD-negative remissions improved; benefit maintained when censored at transplant. Lancet 2023. Basis for the July 2023 US approval. Its inclusion of patients up to 75 extended the RATIFY concept to older adults.
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.
539 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Quizartinib + 7+3 | 268 | 31.9 months | 0.776 (0.615 to 0.979) | 0.032 | link |
| Placebo + 7+3 | 271 | 15.1 months |
Shares Richard M. Stone, FLT3 inhibitor + intensive chemotherapy, Cytarabine + anthracycline ('7+3'), FLT3.
Shares Quizartinib, FLT3-mutated acute myeloid leukaemia, Daiichi Sankyo, Acute myeloid leukaemia.
Shares Quizartinib, Daiichi Sankyo, Acute myeloid leukaemia, Small-molecule kinase inhibitors.
Shares Quizartinib, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, FLT3, FLT3-mutated acute myeloid leukaemia.
Shares Quizartinib, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Quizartinib, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia, Small-molecule kinase inhibitors.
Shares FLT3 inhibitor + intensive chemotherapy, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, FLT3, FLT3-mutated acute myeloid leukaemia.