Table 2.
Summary of adverse events of RELATIVITY-047 [8••]. Adapted from Tawbi et al., N Engl J Med. 2022
| Adverse Event | Relatlimab-Nivolumab (N = 359) |
Nivolumab (N = 355) |
||
|---|---|---|---|---|
| Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | |
| number of events (%) | ||||
| Any adverse event | 345 (97.2) | 143 (40.3) | 339 (94.4) | 120 (33.4) |
| Treatment-related adverse event | 288 (81.1) | 67 (18.9) | 251 (69.9) | 35 (9.7) |
| Led to discontinuation of treatment | 52 (14.6) | 30 (8.5) | 24 (6.7) | 11 (3.1) |
| Treatment-related adverse event in ≥ 10% of patients in the relatlimab–nivolumab group | ||||
| Pruritus | 83 (23.4) | 0 | 57 (15.9) | 2 (0.6) |
| Fatigue | 82 (23.1) | 4 (1.1) | 46 (12.8) | 1 (0.3) |
| Rash | 55 (15.5) | 3 (0.8) | 43 (12.0) | 2 (0.6) |
| Arthralgia | 51 (14.4) | 3 (0.8) | 26 (7.2) | 1 (0.3) |
| Hypothyroidism | 51 (14.4) | 0 | 43 (12.0) | 0 |
| Diarrhea | 48 (13.5) | 3 (0.8) | 33 (9.2) | 2 (0.6) |
| Vitiligo | 37 (10.4) | 0 | 35 (9.7) | 0 |
| Immune-mediated adverse events | ||||
| Hypothyroidism or thyroiditis | 64 (18.0) | 0 | 50 (13.9) | 0 |
| Rash | 33 (9.3) | 2 (0.6) | 24 (6.7) | 5 (1.4) |
| Diarrhea or colitis | 24 (6.8) | 4 (1.1) | 11 (3.1) | 5 (1.4) |
| Hyperthyroidism | 22 (6.2) | 0 | 24 (6.7) | 0 |
| Hepatitis | 20 (5.6) | 14 (3.9) | 9 (2.5) | 4 (1.1) |
| Adrenal insufficiency | 15 (4.2) | 5 (1.4) | 3 (0.8) | 0 |
| Pneumonitis | 13 (3.7) | 2 (0.6) | 6 (1.7) | 2 (0.6) |
| Hypophysitis | 9 (2.5) | 1 (0.3) | 3 (0.8) | 1 (0.3) |
| Nephritis and renal dysfunction | 7 (2.0) | 4 (1.1) | 5 (1.4) | 4 (1.1) |