Signs and symptoms and time of onset of DS by study and type of AML
| Study number/treatment type population . | AG221-C-001 monotherapy . | AG221-AML-004 monotherapy . | AG221-AML-005 AZA combo∗ . | AG120-221-C-001 7 + 3 combo† . | All studies pooled . | |||
|---|---|---|---|---|---|---|---|---|
| ND AML n = 39 n (%) . | R/R AML n = 280 n (%) . | R/R AML n = 157 n (%) . | ND AML n = 74 n (%) . | ND AML n = 93 n (%) . | R/R AML n = 437 n (%) . | ND AML n = 206 n (%) . | Total AML N = 643 n (%) . | |
| Patients with >1 DS event‡ | 5 (12.8) | 33 (11.8) | 14 (8.9) | 13 (17.6) | 2 (2.2) | 47 (10.8) | 20 (9.7) | 67 (10.4) |
| Signs and symptoms for all DS events§ | ||||||||
| Dyspnea/hypoxia | 4 (80.0) | 28 (84.8) | 9 (64.3) | 11 (84.6) | 2 (100.0) | 37 (78.7) | 17 (85.0) | 54 (80.6) |
| Pulmonary infiltrate | 4 (80.0) | 24 (72.7) | 8 (57.1) | 11 (84.6) | 2 (100.0) | 32 (68.1) | 17 (85.0) | 49 (73.1) |
| Unexplained fever | 2 (40.0) | 25 (75.8) | 8 (57.1) | 11 (84.6) | 2 (100.0) | 33 (70.2) | 15 (75.0) | 48 (71.6) |
| Required oxygen supplementation‖ | 3 (60.0) | 18 (54.5) | 7 (50.0) | 9 (69.2) | 0 | 25 (53.2) | 12 (60.0) | 37 (55.2) |
| Pleural effusion | 4 (80.0) | 13 (39.4) | 5 (35.7) | 9 (69.2) | 1 (50.0) | 18 (38.3) | 14 (70.0) | 32 (47.8) |
| Serum creatinine increase | 4 (80.0) | 13 (39.4) | 5 (35.7) | 4 (30.8) | 0 | 18 (38.3) | 8 (40.0) | 26 (38.8) |
| Edema or rapid weight gain | 1 (20.0) | 7 (21.2) | 5 (35.7) | 5 (38.5) | 0 | 12 (25.5) | 6 (30.0) | 18 (26.9) |
| Pericardial effusion | 4 (80.0) | 5 (15.2) | 1 (7.1) | 3 (23.1) | 0 | 6 (12.8) | 7 (35.0) | 13 (19.4) |
| Rash | 0 | 8 (24.2) | 2 (14.3) | 3 (23.1) | 0 | 10 (21.3) | 3 (15.0) | 13 (19.4) |
| Bone pain | 1 (20.0) | 6 (18.2) | 3 (21.4) | 1 (7.7) | 0 | 9 (19.1) | 2 (10.0) | 11 (16.4) |
| Time to onset of first DS, d | ||||||||
| Median | 48.0 | 32.0 | 27.0 | 42.0 | 38.5 | 32.0 | 42.5 | 32.0 |
| Min, max | 10.0, 99.0 | 9.0, 129.0 | 5.0, 122.0 | 4.0, 84.0 | 29.0, 48.0 | 5.0, 129.0 | 4.0, 99.0 | 4.0, 129.0 |
| Study number/treatment type population . | AG221-C-001 monotherapy . | AG221-AML-004 monotherapy . | AG221-AML-005 AZA combo∗ . | AG120-221-C-001 7 + 3 combo† . | All studies pooled . | |||
|---|---|---|---|---|---|---|---|---|
| ND AML n = 39 n (%) . | R/R AML n = 280 n (%) . | R/R AML n = 157 n (%) . | ND AML n = 74 n (%) . | ND AML n = 93 n (%) . | R/R AML n = 437 n (%) . | ND AML n = 206 n (%) . | Total AML N = 643 n (%) . | |
| Patients with >1 DS event‡ | 5 (12.8) | 33 (11.8) | 14 (8.9) | 13 (17.6) | 2 (2.2) | 47 (10.8) | 20 (9.7) | 67 (10.4) |
| Signs and symptoms for all DS events§ | ||||||||
| Dyspnea/hypoxia | 4 (80.0) | 28 (84.8) | 9 (64.3) | 11 (84.6) | 2 (100.0) | 37 (78.7) | 17 (85.0) | 54 (80.6) |
| Pulmonary infiltrate | 4 (80.0) | 24 (72.7) | 8 (57.1) | 11 (84.6) | 2 (100.0) | 32 (68.1) | 17 (85.0) | 49 (73.1) |
| Unexplained fever | 2 (40.0) | 25 (75.8) | 8 (57.1) | 11 (84.6) | 2 (100.0) | 33 (70.2) | 15 (75.0) | 48 (71.6) |
| Required oxygen supplementation‖ | 3 (60.0) | 18 (54.5) | 7 (50.0) | 9 (69.2) | 0 | 25 (53.2) | 12 (60.0) | 37 (55.2) |
| Pleural effusion | 4 (80.0) | 13 (39.4) | 5 (35.7) | 9 (69.2) | 1 (50.0) | 18 (38.3) | 14 (70.0) | 32 (47.8) |
| Serum creatinine increase | 4 (80.0) | 13 (39.4) | 5 (35.7) | 4 (30.8) | 0 | 18 (38.3) | 8 (40.0) | 26 (38.8) |
| Edema or rapid weight gain | 1 (20.0) | 7 (21.2) | 5 (35.7) | 5 (38.5) | 0 | 12 (25.5) | 6 (30.0) | 18 (26.9) |
| Pericardial effusion | 4 (80.0) | 5 (15.2) | 1 (7.1) | 3 (23.1) | 0 | 6 (12.8) | 7 (35.0) | 13 (19.4) |
| Rash | 0 | 8 (24.2) | 2 (14.3) | 3 (23.1) | 0 | 10 (21.3) | 3 (15.0) | 13 (19.4) |
| Bone pain | 1 (20.0) | 6 (18.2) | 3 (21.4) | 1 (7.7) | 0 | 9 (19.1) | 2 (10.0) | 11 (16.4) |
| Time to onset of first DS, d | ||||||||
| Median | 48.0 | 32.0 | 27.0 | 42.0 | 38.5 | 32.0 | 42.5 | 32.0 |
| Min, max | 10.0, 99.0 | 9.0, 129.0 | 5.0, 122.0 | 4.0, 84.0 | 29.0, 48.0 | 5.0, 129.0 | 4.0, 99.0 | 4.0, 129.0 |
DS study and type of AML included ND or R/R AML; and AML safety population.
AML, acute myeloid leukemia; AZA, azacitidine; combo, combination; DS, differentiation syndrome; min, minimum; max, maximum; ND, newly diagnosed; R/R, relapsed or refractory.
Patients were treated with enasidenib (100 mg or 200 mg per day) in combination with azacitidine 75 mg/m2 per day.
Patients were treated with enasidenib (100 mg once daily) in combination with cytarabine (200 mg/m2 per day for 7 days) and either daunorubicin (60 mg/m2 per day for 3 days) or idarubicin (12 mg/m2 per day for 3 days).
Percentage for patients with at >1 DS event was based on number of patients in the safety population.
Percentage for each sign and symptom was calculated based on the number of patients reporting a DS event and not the total number.
This category is separate from “dyspnea/hypoxia” as either event may not require oxygen supplementation.