Skip to content
Bending the Curve Trial by Trial
?

QUAZAR AML-001

Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission

Phase 3N = 472NCT01757535

Population
AML in first remission (complete remission with or without complete blood count recovery) after intensive chemotherapy, age 55 years or older (median 68 years, range 55 to 86), not candidates for hematopoietic stem-cell transplantation
Design
Randomized, double-blind, placebo-controlled phase 3 trial of the oral formulation of azacitidine (CC-486, 300 mg once daily for 14 days per 28-day cycle) or placebo as maintenance. CC-486 is not bioequivalent to injectable azacitidine. Primary end point: overall survival; secondary end points included relapse-free survival and health-related quality of life.
Primary endpoint
OS
Arms
  • Oral azacitidine (CC-486) (experimental, n = 238): CC-486 300 mg orally once daily for 14 days per 28-day cycle
  • Placebo (control, n = 234): Placebo once daily for 14 days per 28-day cycle
People
Wei AH
Δ median OS+9.9 monthsΔ median RFS+5.4 months
Show the numbers
Results reported for QUAZAR AML-001
EndpointAnalysisOral azacitidine (CC-486)PlaceboEffect
OSRandomized patients (N = 472); the abstract does not use the term ITTprimaryWei 2020median 24.7 monthsmedian 14.8 monthsP<0.001The abstract does not give a hazard ratio.
RFSRandomized patients (N = 472); the abstract does not use the term ITTprimaryWei 2020median 10.2 monthsmedian 4.8 monthsP<0.001Secondary end point.
Results reported for QUAZAR AML-001
EndpointAnalysisOral azacitidine (CC-486)PlaceboEffect
OSRandomized patients (N = 472); the abstract does not use the term ITTprimaryWei 2020median 24.7 monthsmedian 14.8 monthsP<0.001The abstract does not give a hazard ratio.
RFSRandomized patients (N = 472); the abstract does not use the term ITTprimaryWei 2020median 10.2 monthsmedian 4.8 monthsP<0.001Secondary end point.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030405060Months (modelled)
  • Oral azacitidine (CC-486) (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsOral azacitidine (CC-486)Placebo
0100.0%100.0%
1565.6%49.5%
3141.9%23.4%
4627.5%11.6%
6217.6%5.5%
Illustrative — modelled from reported values, not trial data. RFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Oral azacitidine (CC-486) (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsOral azacitidine (CC-486)Placebo
0100.0%100.0%
666.5%42.0%
1341.3%15.3%
1927.5%6.4%
2617.1%2.3%
Primary publication: Wei AH, Döhner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, et al. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020;383(26):2526-2537. PubMedDOI

Appears in

Sources

  1. Wei AH, Döhner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, et al. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020;383(26):2526-2537.

    PubMedDOI