Table 2.
Summary of adverse events in the safety population
| Adverse events, n (%) | MSC-1 Q3W |
Overall (n = 41) | ||||
|---|---|---|---|---|---|---|
| 75 mg (n = 2) | 225 mg (n = 1) | 750 mg (n = 10) | 1125 mg (n = 10) | 1500 mg (n = 18) | ||
| Overall (all-cause) Grade ≥3 |
2 (100) 2 (100) |
1 (100) — |
10 (100) 7 (70.0) |
10 (100) 4 (40.0) |
18 (100) 10 (55.6) |
41 (100) 23 (56.1) |
| TRAEs Grade ≥3 |
1 (50.0) 1 (50.0) |
1 (100) — |
4 (40.0) — |
3 (30.0) — |
10 (55.6) — |
19 (46.3) 1 (2.4) |
| Serious AEs | 2 (100) | – | 7 (70.0) | 1 (10.0) | 9 (50.0) | 19 (46.3) |
| Serious TRAEs | — | — | — | — | 1 (5.6) | 1 (2.4) |
| Fatal AEsa Fatal TRAEs |
1 (50.0) — |
— — |
1 (10.0) — |
— — |
3 (16.7) — |
5 (12.2) — |
| DLTs | — | — | — | — | — | — |
| Infusion-related AEs | — | 1 (100) | 1 (10.0) | — | — | 2 (4.9) |
| Patients whose MSC-1 treatment was: | ||||||
| Delayed due to AE | — | — | 1 (10.0) | — | — | 1 (2.4) |
| Interrupted due to AE | — | — | 1 (10.0) | — | 1 (5.6) | 2 (4.9) |
| Withdrawn due to AE | — | — | — | — | — | — |
AE, adverse event; Q3W, once every 3 weeks; TRAE, treatment-related adverse event.
a
Four fatal AEs were due to disease progression: one multi-organ failure in a patient with metastatic pancreatic cancer; one cardiac arrest in a patient with metastatic non-small-cell lung cancer; one case of hepatic insufficiency due to progressive pancreatic cancer; and one case of metastatic non-small-cell lung cancer with respiratory failure. Additionally, there was one sudden death not otherwise specified, considered unrelated to study treatment.