Table 4.
Pooled patient-level toxicity data of CD47-SIRPα inhibitors in clinical trials.
| Total patients (n=942, %) | Anti-CD47 mAbs (n=448, %) | Selective SIRPɑ blockers (n=494, %) | p value | |
|---|---|---|---|---|
| DLT | 31 (3.3) | 24 (5.4) | 7 (1.4) | 0.01* |
| SAE | 63 (6.7) | 34 (7.6) | 29 (5.9) | 0.11 |
| TRAE grade 3 | 170 (18.0) | 86 (19.2) | 84 (17.0) | 0.082 |
| TRAE Grade 3-4 | ||||
| Thrombocytopenia | 57 (6.1) | 16 (3.6) | 41 (8.3) | 0.62 |
| Neutropenia | 52 (5.5) | 29 (6.5) | 23 (4.7) | 0.98 |
| Anemia | 43 (4.6) | 26 (5.8) | 17 (3.4) | 0.24 |
| IRR | 11 (1.2) | 6 (1.3) | 5 (1) | 0.41 |
| Bilirubin inc | 4 (0.4) | 4 (0.9) | 0 (0) | |
| Amylase/lipase inc | 3 (0.3) | 1 (0.2) | 2 (0.4) | 0.89 |
| Fatigue | 2 (0.2) | 1 (0.2) | 1 (0.2) | 0.58 |
| Hypotension | 2 (0.2) | 0 (0) | 2 (0.4) | |
| Chills | 1 (0.1) | 1 (0.2) | 0 (0) | |
| Diarrhea | 1 (0.1) | 0 (0) | 1 (0.2) | |
| Fever | 1 (0.1) | 1 (0.2) | 0 (0) | |
| Nausea/vomiting | 1 (0.1) | 0 (0) | 1 (0.2) | |
| Headache | 1 (0.1) | 1 (0.2) | 0 (0) | |
| LFT inc | 1 (0.1) | 0 (0) | 1 (0.2) | |
| Rash | 1 (0.1) | 0 (0) | 1 (0.2) | |
| Electrolyte change | 0 (0) | 0 (0) | 0 (0) | |
| TRAE Grade 1-2 | ||||
| Fatigue | 200 (21.2) | 122 (27.2) | 78 (15.8) | 0.11 |
| IRR | 193 (20.5) | 79 (17.6) | 114 (23.1) | 0.32 |
| Headache | 118 (12.5) | 94 (21.0) | 24 (4.9) | 0.002* |
| Anemia | 112 (11.9) | 92 (20.5) | 20 (4.0) | 0.0002* |
| Chills | 99 (10.5) | 59 (13.2) | 40 (8.1) | 0.002* |
| Nausea/vomiting | 94 (10) | 65 (14.5) | 29 (5.9) | 0.005* |
| Fever | 86 (9.1) | 58 (12.9) | 28 (5.7) | 0.042* |
| Thrombocytopenia | 60 (6.4) | 34 (7.6) | 26 (5.3) | 0.065 |
| Diarrhea | 56 (5.9) | 34 (7.6) | 22 (4.5) | 0.21 |
| Rash | 46 (4.9) | 29 (6.5) | 17 (3.4) | 0.24 |
| Bilirubin inc | 22 (2.3) | 22 (4.9) | 0 (0) | |
| Neutropenia | 22 (2.3) | 14 (3.1) | 8 (1.6) | 0.15 |
| LFT inc | 19 (2) | 0 (0) | 19 (3.8) | |
| Arthralgia | 18 (1.9) | 8 (1.8) | 10 (2) | 0.65 |
| Pruritus | 17 (1.8) | 0 (0) | 17 (3.4) | |
| Amylase/lipase inc | 11 (1.2) | 10 (2.2) | 1 (0.2) | 0.99 |
| Anorexia | 9 (1) | 0 (0) | 9 (1.8) | |
| Hypotension | 6 (0.6) | 0 (0) | 6 (1.2) | |
| Electrolyte change | 2 (0.2) | 0 (0) | 2 (0.4) | |
| Pneumonitis | 1 (0.1) | 0 (0) | 1 (0.2) | |
*p<0.05.
DLT, dose-limiting toxicity; inc, increased; IRR, infusion-related reaction; LFT, liver function test; mAb, monoclonal antibody; SAE, serious adverse event; TRAE, treatment-related adverse events.