Written in Blood
years) with low or intermediate-1 risk MDS or
chronic myelomonocytic leukemia (CMML;
per the International Prognostic Scoring
System [IPSS]) between November 2012 and
February 2016. Patients with other active and
uncontrolled infection or intercurrent illnesses,
or who had received any prior therapy with
HMAs were excluded. Most patients (90%)
had good or intermediate-risk cytogenetics.
The majority of patients had MDS (n=97),
including 20 (18%) with therapy-related
MDS; six patients (5%) had an overlap MDS/
myeloproliferative neoplasm (MPN) other than
CMML, and 16 (14%) had CMML.
Using a Bayesian response-adaptive design,
investigators randomized patients to receive:
• decitabine 20 mg/m 2 intravenously daily
for 3 days (n=73)
• azacitidine 75 mg/m 2 intravenously daily
for 3 days (n=40)
Other notable adverse drug reactions that occurred in less than 10% of
patients treated with VYXEOS during induction or consolidation included:
• Ear and labyrinth disorders: Deafness, Deafness unilateral
• Eye Disorders: Eye conjunctivitis, Dry eye, Eye edema, Eye swelling,
Eye irritation, Eye pain, Ocular discomfort, Ocular hyperemia,
Periorbital edema, Scleral hyperemia
• Gastrointestinal disorders: Dyspepsia
• Psychiatric disorders: Hallucinations
• Respiratory, thoracic and mediastinal disorders: Pneumonitis
Laboratory Abnormalities
All patients developed severe neutropenia, thrombocytopenia, and anemia.
See Table 3 for the incidences of Grade 3 thrombocytopenia and Grade 4
neutropenia that were prolonged in the absence of active leukemia.
Table 3: Prolonged Cytopenias for Patients in Study 1
Induction 1
VYXEOS
7+3
N=58
N=34
n (%)
n (%)
Prolonged
thrombocytopenia a
Prolonged
neutropenia a
Consolidation 1 b
VYXEOS
5+2
N=48
N=32
n (%)
n (%)
16 (28) 4 (12) 12 (25) 5 (16)
10 (17) 1 (3) 5 (10) 1 (3)
Platelets <50 Gi/L or neutrophils <0.5 Gi/L lasting past cycle day 42
in the absence of active leukemia.
b
Patients receiving at least 1 consolidation.
a
Grade 3-4 chemistry abnormalities occurring in greater than 5%
of VYXEOS treated patients in Study 1 are presented in Table 4.
Table 4: Grade 3-4 a Chemistry Abnormalities ≥5% of VYXEOS
Treated Patients in Study 1
Induction
VYXEOS
7+3
N=153
N=151
n (%)
n (%)
Chemistry Abnormalities
Hyponatremia
21 (14)
20 (13)
Hypokalemia
14 (9)
19 (13)
Hypoalbuminemia
11 (7)
19 (13)
Hyperbilirubinemia
9 (6)
6 (4)
Alanine
7 (5)
8 (5)
aminotransferase
Consolidation
VYXEOS
5+2
N=49
N=32
n (%)
n (%)
3 (6)
3 (6)
1 (2)
1 (2) 0
2 (6)
4 (13)
1 (3)
0 1 (3)
Graded using NCI CTCAE version 3.0.
a
DRUG INTERACTIONS
Cardiotoxic Agents
Concomitant use of cardiotoxic agents may increase the risk of
cardiotoxicity. Assess cardiac function more frequently when VYXEOS
is coadministered with cardiotoxic agents [see Warnings and Precautions].
Hepatotoxic Agents
Concomitant use with hepatotoxic agents may impair liver function
and increase the toxicity of VYXEOS. Monitor hepatic function more
frequently when VYXEOS is coadministered with hepatotoxic agents.
The imbalance in treatment groups was “d