QuANTUM-First
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.
Setting
Newly diagnosed FLT3-ITD AML, age 18-75: quizartinib vs placebo with 7+3, consolidation, and up to 3 years of maintenance
Phase
Phase 3
Sponsor
Daiichi Sankyo
Registry
Headline result
OS 31.9 vs 15.1 months; HR 0.776.
Reported
2022
Enrolled
539
Replication
Consistent with RATIFY (midostaurin); the FLT3-inhibitor-plus-7+3 effect has now been shown with two different molecules.
In plain words
What these results mean for people, not percentages
Overall survival (median)primarysurvival endpoint
- Median 31.9 vs 15.1 months with Quizartinib + 7+3 compared with Placebo + 7+3; about 16.8 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 22 percent lower chance of the event at any given time (hazard ratio 0.776, likely range 0.615 to 0.979).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Newly diagnosed FLT3-ITD AML, age 18-75: quizartinib vs placebo with 7+3, consolidation, and up to 3 years of maintenance. 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.
539 participants enrolled.
Overall survival (median)primary
HR 0.776 (0.615–0.979) · p = 0.032
Quizartinib + 7+3
31.9 mo
Placebo + 7+3
15.1 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Quizartinib + 7+3 | 268 | 31.9 months | 0.776 (0.615–0.979) | 0.032 | link |
| Placebo + 7+3 | 271 | 15.1 months |
Replication
Consistent with RATIFY (midostaurin); the FLT3-inhibitor-plus-7+3 effect has now been shown with two different molecules.