VYXEOS safety profile in the Phase 3 trial1
Common adverse reactions (≥20% incidence in the VYXEOS arm) during the induction phase1
Adverse reaction | All gradesa | Grades 3 to 5a | ||
---|---|---|---|---|
VYXEOS (N=153) n (%) |
7+3 (N=151) n (%) |
VYXEOS (N=153) n (%) |
7+3 (N=151) n (%) |
|
Hemorrhage | 107 (70) | 74 (49) | 15 (10) | 9 (6) |
Febrile neutropenia | 104 (68) | 103 (68) | 101 (66) | 102 (68) |
Rash | 82 (54) | 55 (36) | 8 (5) | 2 (1) |
Edema | 78 (51) | 90 (60) | 2 (2) | 5 (3) |
Nausea | 72 (47) | 79 (52) | 1 (1) | 1 (1) |
Diarrhea/colitis | 69 (45) | 100 (66) | 4 (3) | 10 (7) |
Mucositis | 67 (44) | 69 (46) | 2 (1) | 7 (5) |
Constipation | 61 (40) | 57 (38) | 0 | 0 |
Musculoskeletal pain | 58 (38) | 52 (34) | 5 (3) | 4 (3) |
Abdominal pain | 51 (33) | 45 (30) | 3 (2) | 3 (2) |
Cough | 51 (33) | 34 (23) | 0 | 1 (1) |
Headache | 51 (33) | 36 (24) | 2 (1) | 1 (1) |
Dyspnea | 49 (32) | 51 (34) | 17 (11) | 15 (10) |
Fatigue | 49 (32) | 58 (38) | 8 (5) | 8 (5) |
Arrhythmia | 46 (30) | 41 (27) | 10 (7) | 7 (5) |
Decreased appetite | 44 (29) | 57 (38) | 2 (1) | 5 (3) |
Pneumonia (excluding fungal) | 39 (26) | 35 (23) | 30 (20) | 26 (17) |
Sleep disorders | 38 (25) | 42 (28) | 2 (1) | 1 (1) |
Bacteremia (excluding sepsis) | 37 (24) | 37 (25) | 35 (23) | 31 (21) |
Vomiting | 37 (24) | 33 (22) | 0 | 0 |
Chills | 35 (23) | 38 (25) | 0 | 0 |
Hypotension | 30 (20) | 32 (21) | 7 (5) | 1 (1) |
Non-conduction cardiotoxicity | 31 (20) | 27 (18) | 13 (9) | 15 (10) |
Adverse reaction | All gradesa | |
---|---|---|
VYXEOS (N=153) n (%) |
7+3 (N=151) n (%) |
|
Hemorrhage | 107 (70) | 74 (49) |
Febrile neutropenia | 104 (68) | 103 (68) |
Rash | 82 (54) | 55 (36) |
Edema | 78 (51) | 90 (60) |
Nausea | 72 (47) | 79 (52) |
Diarrhea/colitis | 69 (45) | 100 (66) |
Mucositis | 67 (44) | 69 (46) |
Constipation | 61 (40) | 57 (38) |
Musculoskeletal pain | 58 (38) | 52 (34) |
Abdominal pain | 51 (33) | 45 (30) |
Cough | 51 (33) | 34 (23) |
Headache | 51 (33) | 36 (24) |
Dyspnea | 49 (32) | 51 (34) |
Fatigue | 49 (32) | 58 (38) |
Arrhythmia | 46 (30) | 41 (27) |
Decreased appetite | 44 (29) | 57 (38) |
Pneumonia (excluding fungal) | 39 (26) | 35 (23) |
Sleep disorders | 38 (25) | 42 (28) |
Bacteremia (excluding sepsis) | 37 (24) | 37 (25) |
Vomiting | 37 (24) | 33 (22) |
Chills | 35 (23) | 38 (25) |
Hypotension | 30 (20) | 32 (21) |
Non-conduction cardiotoxicity | 31 (20) | 27 (18) |
Adverse reaction | Grades 3 to 5a | |
---|---|---|
VYXEOS (N=153) n (%) |
7+3 (N=151) n (%) |
|
Hemorrhage | 15 (10) | 9 (6) |
Febrile neutropenia | 101 (66) | 102 (68) |
Rash | 8 (5) | 2 (1) |
Edema | 2 (2) | 5 (3) |
Nausea | 1 (1) | 1 (1) |
Diarrhea/colitis | 4 (3) | 10 (7) |
Mucositis | 2 (1) | 7 (5) |
Constipation | 0 | 0 |
Musculoskeletal pain | 5 (3) | 4 (3) |
Abdominal pain | 3 (2) | 3 (2) |
Cough | 0 | 1 (1) |
Headache | 2 (1) | 1 (1) |
Dyspnea | 17 (11) | 15 (10) |
Fatigue | 8 (5) | 8 (5) |
Arrhythmia | 10 (7) | 7 (5) |
Decreased appetite | 2 (1) | 5 (3) |
Pneumonia (excluding fungal) | 30 (20) | 26 (17) |
Sleep disorders | 2 (1) | 1 (1) |
Bacteremia (excluding sepsis) | 35 (23) | 31 (21) |
Vomiting | 0 | 0 |
Chills | 0 | 0 |
Hypotension | 7 (5) | 1 (1) |
Non-conduction cardiotoxicity | 13 (9) | 15 (10) |
- Adverse reactions were graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.1
Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the VYXEOS arm and 0.7% in the control arm (7+3)1
Other adverse reactions that occurred in ≥10% of patients in the VYXEOS arm included: dizziness, fungal infection, hypertension, hypoxia, upper respiratory infections (excluding fungal), chest pain, pyrexia, catheter/device/injection site reaction, delirium, pleural effusion, anxiety, pruritus, sepsis (excluding fungal), hemorrhoids, petechiae, renal insufficiency, transfusion reactions, and visual impairment (except bleeding)1
The safety population included all patients in the VYXEOS cohort and 151 patients from the 7+3 cohort (5 patients withdrew consent before the receipt of treatment)2
Time to recovery of absolute neutrophil count and platelets may be prolonged with VYXEOS and require additional monitoring1
- Incidences of Grade 3 thrombocytopeniab were prolonged in the absence of active leukemia in 28% (16/58) of patients in the VYXEOS arm and 12% (4/34) in the 7+3 arm during Induction 1 and in 25% (12/48) in the VYXEOS arm and 16% (5/32) in the 5+2 arm during Consolidation 1c
- Incidences of Grade 4 neutropeniab were prolonged in the absence of active leukemia in 17% (10/58) of patients in the VYXEOS arm and 3% (1/34) in the 7+3 arm during Induction 1 and in 10% (5/48) in the VYXEOS arm and 3% (1/32) in the 5+2 arm during Consolidation 1c
- Platelets <50 Gi/L or neutrophils <0.5 Gi/L lasting past cycle day 42 in the absence of active leukemia.1
- Patients receiving at least 1 consolidation.1