Table 2.
Treatment-related adverse events in ≥15% patients by PF-06804103 doses (the safety analysis set).
| Part 1A | Part 2A | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HER2+ BC or GC | Total | HER2+ BC | HR+ HER2-Low BC | Total | Total | |||||||||
| PF-06804103 doses, mg/kg | 0.15 | 0.5 | 1.2 | 2.0 | 3.0 | 4.0 | 5.0 | 0.15–5.0 | 3.0 | 4.0 | 3.0 | 4.0 | 3.0–4.0 | 0.15–5.0 |
| N | 2 | 2 | 2 | 4 | 16 | 15 | 6 | 47 | 5 | 14 | 12 | 15 | 46 | 93 |
| With any adverse event | 1 (50.0) | 1 (50.0) | 1 (50.0) | 4 (100.0) | 15 (93.8) | 15 (100.0) | 6 (100.0) | 43 (91.5) | 5 (100.0) | 14 (100.0) | 10 (83.3) | 15 (100.0) | 44 (95.7) | 87 (93.5) |
| Alopecia | 0 | 0 | 0 | 4 (100.0) | 4 (25.0) | 10 (66.7) | 3 (50.0) | 21 (44.7) | 1 (20.0) | 5 (35.7) | 6 (50.0) | 9 (60.0) | 21 (45.7) | 42 (45.2) |
| Fatigue | 0 | 0 | 1 (50.0) | 2 (50.0) | 9 (56.3) | 4 (26.7) | 4 (66.7) | 20 (42.6) | 2 (40.0) | 5 (35.7) | 4 (33.3) | 1 (6.7) | 12 (26.1) | 32 (34.4) |
| Neuropathy peripheral | 0 | 0 | 0 | 0 | 8 (50.0) | 3 (20.0) | 3 (50.0) | 14 (29.8) | 0 | 1 (7.1) | 2 (16.7) | 4 (26.7) | 7 (15.2) | 21 (22.6) |
| Peripheral sensory neuropathy | 0 | 0 | 0 | 2 (50.0) | 3 (18.8) | 6 (40.0) | 2 (33.3) | 13 (27.7) | 1 (20.0) | 7 (50.0) | 3 (25.0) | 5 (33.3) | 16 (34.8) | 29 (31.2) |
| Decreased appetite | 0 | 0 | 0 | 1 (25.0) | 4 (25.0) | 5 (33.3) | 2 (33.3) | 12 (25.5) | 2 (40.0) | 2 (14.3) | 3 (25.0) | 2 (13.3) | 9 (19.6) | 21 (22.6) |
| Myalgia | 0 | 0 | 0 | 0 | 5 (31.3) | 5 (33.3) | 2 (33.3) | 12 (25.5) | 0 | 7 (50.0) | 4 (33.3) | 5 (33.3) | 16 (34.8) | 28 (30.1) |
| Rash | 0 | 0 | 0 | 0 | 3 (18.8) | 5 (33.3) | 2 (33.3) | 10 (21.3) | 2 (40.0) | 6 (42.9) | 3 (25.0) | 3 (20.0) | 14 (30.4) | 24 (25.8) |
| Weight decreased | 0 | 0 | 0 | 0 | 3 (18.8) | 4 (26.7) | 3 (50.0) | 10 (21.3) | 1 (20.0) | 4 (28.6) | 2 (16.7) | 3 (20.0) | 10 (21.7) | 20 (21.5) |
| Arthralgia | 0 | 1 (50.0) | 0 | 0 | 3 (18.8) | 4 (26.7) | 1 (16.7) | 9 (19.1) | 1 (20.0) | 3 (21.4) | 4 (33.3) | 5 (33.3) | 13 (28.3) | 22 (23.7) |
| Stomatitis | 0 | 1 (50.0) | 0 | 0 | 2 (12.5) | 4 (26.7) | 2 (33.3) | 9 (19.1) | 1 (20.0) | 4 (28.6) | 3 (25.0) | 2 (13.3) | 10 (21.7) | 19 (20.4) |
| Anemia | 0 | 0 | 1 (50.0) | 0 | 3 (18.8) | 2 (13.3) | 2 (33.3) | 8 (17.0) | 0 | 3 (21.4) | 2 (16.7) | 2 (13.3) | 7 (15.2) | 15 (16.1) |
| Diarrhea | 1 (50.0) | 0 | 1 (50.0) | 0 | 2 (12.5) | 2 (13.3) | 2 (33.3) | 8 (17.0) | 1 (20.0) | 1 (7.1) | 0 | 5 (33.3) | 7 (15.2) | 15 (16.1) |
| Nausea | 0 | 0 | 0 | 1 (25.0) | 2 (12.5) | 2 (13.3) | 2 (33.3) | 7 (14.9) | 0 | 3 (21.4) | 2 (16.7) | 3 (20.0) | 8 (17.4) | 15 (16.1) |
Note: Values are n (%). MedDRA v24.1 coding dictionary applied.
Abbreviations: BC, breast cancer; GC, gastric and gastroesophageal cancer; MedDRA, Medical Dictionary for Regulatory Activities; N, number of patients in each group.