1100 mg AMG 820 + 200 mg pembrolizumab (n=98) | 1400 mg AMG 820 + 200 mg pembrolizumab (n=18) | All patients (N=116) | ||||
All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | |
Patients reporting treatment-emergent adverse events, n (%) | 97 (99.0) | 87 (88.8) | 18 (100.0) | 15 (83.3) | 115 (99.1) | 102 (87.9) |
Aspartate aminotransferase increased | 58 (59.2) | 28 (28.6) | 11 (61.1) | 4 (22.2) | 69 (59.5) | 32 (27.6) |
Fatigue | 48 (49.0) | 4 (4.1) | 8 (44.4) | 2 (11.1) | 56 (48.3) | 6 (5.2) |
Periorbital/face edema | 46 (46.9) | 1 (1.0) | 10 (55.6) | 1 (5.6) | 56 (48.3) | 2 (1.7) |
Rash/maculopapular rash | 37 (37.8) | 12 (12.2) | 6 (33.3) | 1 (5.6) | 43 (37.1) | 13 (11.2) |
Anemia | 31 (31.6) | 19 (19.4) | 3 (16.7) | 1 (5.6) | 34 (29.3) | 20 (17.2) |
Nausea | 27 (27.6) | 1 (1.0) | 6 (33.3) | 0 (0.0) | 33 (28.4) | 1 (0.9) |
Constipation | 20 (20.4) | – | 9 (50.0) | – | 29 (25.0) | – |
Diarrhea | 23 (23.5) | 1 (1.0) | 5 (27.8) | 0 (0.0) | 28 (24.1) | 1 (0.9) |
Pyrexia | 24 (24.5) | 2 (2.0) | 3 (16.7) | 0 (0.0) | 27 (23.3) | 2 (1.7) |
Decreased appetite | 19 (19.4) | 0 (0.0) | 8 (44.4) | 0 (0.0) | 27 (23.3) | 0 (0.0) |
Hypophosphatemia | 18 (18.4) | 9 (9.2) | 7 (38.9) | 3 (16.7) | 25 (21.6) | 12 (10.3) |
Alanine aminotransferase increased | 21 (21.4) | 3 (3.1) | 4 (22.2) | 0 (0.0) | 25 (21.6) | 3 (2.6) |
Amylase increased | 19 (19.4) | 9 (9.2) | 5 (27.8) | 2 (11.1) | 24 (20.7) | 11 (9.5) |
Dyspnea | 21 (21.4) | 5 (5.1) | 3 (16.7) | 0 (0.0) | 24 (20.7) | 5 (4.3) |
Pruritus | 19 (19.4) | – | 4 (22.2) | – | 23 (19.8) | – |
Abdominal pain | 17 (17.3) | 4 (4.1) | 5 (27.8) | 1 (5.6) | 22 (19.0) | 5 (4.3) |
Lipase increased | 18 (18.4) | 12 (12.2) | 4 (22.2) | 3 (16.7) | 22 (19.0) | 15 (12.9) |
Vomiting | 13 (13.3) | – | 4 (22.2) | – | 17 (14.7) | – |
Blood alkaline phosphatase increased | 12 (12.2) | 3 (3.1) | 4 (22.2) | 1 (5.6) | 16 (13.8) | 4 (3.4) |
*In ≥20% of patients in the 1100 mg or 1400 mg group.