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During the Late Breaking Abstracts session held on Tuesday 10th December, 2019, at the 61st American Society of Hematology (ASH) meeting in Orlando, US, Andrew Wei, The Alfred Hospital, Melbourne, AU, presented results from the phase III QUAZAR AML-001 trial.1
QUAZAR AML-001 (NCT01757535) is a phase III randomized, double-blind, placebo-controlled trial investigating the use of CC-486 as maintenance therapy for patients with acute myeloid leukemia (AML), aged 55 or over, who are in first remission after intensive induction chemotherapy (IC), regardless of whether they received consolidation therapy or not. CC-486 is an oral formulation of azacitidine, a hypomethylating agent (HMA).1 Azacitidine is approved for adult patients with AML, who are not eligible for hematopoietic stem cell transplantation (HSCT).2
Patients with AML who receive IC can achieve complete remission (CR), however in the majority of cases, patients subsequently relapse. For many patients, subsequent hematopoietic stem cell transplant (HSCT) is not possible due to comorbidities or other high-risk features. Maintenance therapy aims to suppress the growth of remaining leukemic cells and thereby delaying relapse while maintaining adequate patient quality of life (QoL). Therefore, there is a requirement to develop well-tolerated maintenance therapies that increase the long-term chance of disease control and prolong overall survival (OS).
Read more about maintenance therapy options for patients with AML, as summarized by the AML Global Portal, here.
CC-486 is an orally administered HMA, which has a distinct pharmacodynamic and pharmacokinetic profile compared to injectable azacitidine. The oral administration route allows for prolonged exposure to the drug, extending the therapeutic activity.
CC-486 (n= 238)
Placebo (n= 234)
HR and p values
Median OS
24.7 months
(95% CI, 18.7–30.5)
14.8 months
(95% CI, 11.7–17.6)
HR= 0.69
p= 0.0009
95% CI, 0.55–0.86
1-year survival rate
73%
(95% CI, 67–78)
56%
(95% CI, 49–62)
-
2-year survival rate
51%
(95% CI, 44–57)
37%
(95% CI, 31–43)
-
Median RFS
10.2 months
(95% CI, 7.9–12.9)
4.8 months
(95% CI, 4.6–6.4)
HR= 0.65
p= 0.0001
95% CI, 0.52–0.81
1-year relapse rate
53%
(95% CI, 46–59)
71%
(95% CI, 65–77)
-
CC-486 (n= 236)
Placebo (n= 233)
All grades
Grades 3–4
All grades
Grades 3–4
Patients with ≥1 AE
98%
72%
97%
63%
Gastrointestinal
Nausea
65%
3%
24%
0.4%
Vomiting
60%
3%
10%
0
Diarrhea
50%
5%
22%
1%
Constipation
39%
1%
24%
0
Hematologic
Neutropenia
45%
41%
26%
24%
Thrombocytopenia
34%
23%
27%
22%
Anemia
20%
14%
18%
13%
Other
Fatigue
30%
3%
19%
1%
Asthenia
19%
1%
6%
0.4%
Pyrexia
15%
2%
19%
0.4%
Cough
12%
0
17%
0
Currently there are few options for maintenance therapy in AML. The QUAZAR AML-001 trial is the first to demonstrate a clinically significant improvement in OS and RFS in patients with AML in first remission following induction chemotherapy, regardless of the consolidation therapy received, and across subgroups. Health-related QoL was preserved when compared to placebo, and there were no unexpected AEs. CC-486 is proposed as a new therapeutic maintenance standard for patients aged 55 or over with AML in first remission, who are not eligible for HSCT.
References