Table 3.
Treatment-emergent adverse events (AEs)
| Summary, n (%) | Part 1 dostarlimab dose levels | Part 2A dostarlimab regimens | |||||
|---|---|---|---|---|---|---|---|
| 1 mg/kg, n = 6 | 3 mg/kg, n = 3 | 10 mg/kg, n = 12 | Total, N = 21 | 500 mg Q3W, n = 6 | 1000 mg Q6W, n = 7 | Total N, = 13 | |
| Any AE | 6 (100) | 3 (100) | 12 (100) | 21 (100) | 6 (100) | 7 (100) | 13 (100) |
| Dostarlimab-related AE | 6 (100.0) | 2 (66.7) | 9 (75.0) | 17 (81.0) | 5 (83.3) | 5 (71.4) | 10 (76.9) |
| Any grade ≥ 3 AE | 3 (50.0) | 1 (33.3) | 6 (50.0) | 10 (47.6) | 1 (16.7) | 1 (14.3) | 2 (15.4) |
| Dostarlimab-related grade ≥ 3 AE | 1 (16.7) | 0 | 1 (8.3) | 2 (9.5) | 1 (16.7) | 1 (14.3) | 2 (15.4) |
| Any serious AE | 2 (33.3) | 0 | 6 (50.0) | 8 (38.1) | 1 (16.7) | 1 (14.3) | 2 (15.4) |
| Dostarlimab-related serious AE | 0 | 0 | 1 (8.3)a | 1 (4.8) | 0 | 1 (14.3)b | 1 (7.7) |
| Any AE leading to drug withdrawal | 0 | 0 | 2 (16.7) | 2 (9.5) | 0 | 1 (14.3) | 1 (7.7) |
| Dostarlimab-related AE leading to drug withdrawal | 0 | 0 | 1 (8.3) | 1 (4.8) | 0 | 1 (14.3) | 1 (7.7) |
| Any AE leading to treatment interruption | 1 (16.7) | 2 (66.7) | 3 (25.0) | 6 (28.6) | 2 (33.3) | 0 | 2 (15.4) |
| Any immune-related AE | 0 | 0 | 1 (8.3) | 1 (4.8) | 0 | 1 (14.3) | 1 (7.7) |
| Type of treatment-related AEsc | |||||||
| Fatigue | 1 (16.7) | 2 (66.7) | 4 (33.3) | 7 (33.3) | 2 (33.3) | 3 (42.9) | 5 (38.5) |
| Nausea | 1 (16.7) | 1 (33.3) | 3 (25.0) | 5 (23.8) | 1 (16.7) | 0 | 1 (7.7) |
| Pruritus | 2 (33.3) | 1 (33.3) | 1 (8.3) | 4 (19.0) | 0 | 0 | 0 |
| Arthralgia | 1 (16.7) | 1 (33.3) | 1 (8.3) | 3 (14.3) | 1 (16.7) | 0 | 1 (7.7) |
| Decreased appetite | 2 (33.3) | 1 (33.3) | 0 | 3 (14.3) | 1 (16.7) | 0 | 1 (7.7) |
| Maculopapular rash | 2 (33.3) | 1 (33.3) | 0 | 3 (14.3) | 0 | 0 | 0 |
| Alopecia | 0 | 1 (33.3) | 1 (8.3) | 2 (9.5) | 0 | 0 | 0 |
| Vomiting | 0 | 0 | 2 (16.7) | 2 (9.5) | 0 | 0 | 0 |
| Anemia | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (7.7) |
| Amylase increased | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (14.3) | 2 (15.4) |
| Hypokalemia | 1 (16.7) | 0 | 0 | 1 (4.8) | 1 (16.7) | 1 (14.3) | 2 (15.4) |
aAlanine aminotransferase and aspartate aminotransferase increased
bPneumonitis
cIncidence ≥ 10% in each study part by Medical Dictionary for Regulatory Activities preferred term