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QuANTUM-First

Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial

Phase 3N = 539NCT02668653

Population
Newly diagnosed FLT3-ITD-positive AML, aged 18 to 75 years (median age 56 years)
Design
Randomised (1:1), double-blind, placebo-controlled phase 3 trial at 193 hospitals in 26 countries. Standard 7 + 3 induction (cytarabine with daunorubicin 60 mg/m2 or idarubicin 12 mg/m2), then quizartinib 40 mg or placebo daily for 14 days; consolidation with high-dose cytarabine plus quizartinib or placebo, allogeneic haematopoietic cell transplantation, or both; then single-agent continuation of quizartinib or placebo for up to 3 years. Primary outcome: overall survival in the intention-to-treat population.
Primary endpoint
OS
Arms
  • Quizartinib + chemotherapy (experimental, n = 268): Standard 7 + 3 induction, then quizartinib 40 mg daily for 14 days; consolidation with high-dose cytarabine plus quizartinib 40 mg daily, allogeneic haematopoietic cell transplantation, or both; then single-agent quizartinib continuation for up to 3 years
  • Placebo + chemotherapy (control, n = 271): Standard 7 + 3 induction, then placebo daily for 14 days; consolidation with high-dose cytarabine plus placebo, allogeneic haematopoietic cell transplantation, or both; then single-agent placebo continuation for up to 3 years
People
Erba HP
OSHR 0.78 (95% CI 0.62–0.98)Δ median OS+16.8 months
Show the numbers
Results reported for QuANTUM-First
EndpointAnalysisQuizartinib + chemotherapyPlacebo + chemotherapyEffect
OSprimarymedian follow-up 39.2 monthsErba 2023median 31.9 monthsmedian 15.1 months (13.2–26.2)HR 0.78 (95% CI 0.62–0.98)P=0.032The 95% confidence interval for the quizartinib median is 21.0 to not estimable, so it cannot be stored as an interval here.
Results reported for QuANTUM-First
EndpointAnalysisQuizartinib + chemotherapyPlacebo + chemotherapyEffect
OSprimarymedian follow-up 39.2 monthsErba 2023median 31.9 monthsmedian 15.1 months (13.2–26.2)HR 0.78 (95% CI 0.62–0.98)P=0.032The 95% confidence interval for the quizartinib median is 21.0 to not estimable, so it cannot be stored as an interval here.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.780.62–0.98
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0204060Months (modelled)
  • Quizartinib + chemotherapy (experimental)
  • Placebo + chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsQuizartinib + chemotherapyPlacebo + chemotherapy
0100.0%100.0%
2064.8%39.9%
4041.9%15.9%
6027.2%6.4%
8017.6%2.5%
Primary publication: Erba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, Žák P, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401(10388):1571-1583. PubMedDOI

Appears in

Sources

  1. Erba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, Žák P, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401(10388):1571-1583.

    PubMedDOI