Table 2.
Adverse events (AE) | Favezelimab N = 20 |
Favezelimab + pembrolizumab N = 89a |
||
---|---|---|---|---|
Any AE | 19 (95.0) | 87 (97.8) | ||
Any treatment-related AE | 13 (65.0) | 58 (65.2) | ||
Grade 3-4 | 3 (15.0) | 18 (20.2) | ||
Led to discontinuation | 0 | 5 (5.6) | ||
Immune-mediated AEs | 2 (10.0) | 32 (36.0) | ||
Events ≥5% in any armb | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
Nausea | 3 (15.0) | 0 | 4 (4.5) | 0 |
Fatigue | 4 (20.0) | 1 (5.0) | 15 (16.9) | 2 (2.2) |
Influenza-like illness | 2 (10.0) | 0 | 0 | 0 |
Hypothyroidism | 1 (5.0) | 0 | 13 (14.6) | 0 |
Diarrhea | 1 (5.0) | 0 | 3 (3.4) | 0 |
Vomiting | 1 (5.0) | 0 | 1 (1.1) | 0 |
Pruritus | 1 (5.0) | 0 | 7 (7.9) | 0 |
Maculopapular rash | 1 (5.0) | 0 | 6 (6.7) | 1 (1) |
Rash | 1 (5.0) | 0 | 5 (5.6) | 0 |
Lipase increased | 1 (5.0) | 1 (5.0) | 0 | 0 |
Thyroid function test abnormal | 1 (5.0) | 0 | 0 | 0 |
Syncope | 1 (5.0) | 1 (5.0) | 0 | 0 |
Arthralgia | 1 (5.0) | 0 | 2 (2.2) | 0 |
Back pain | 1 (5.0) | 0 | 1 (1.1) | 0 |
Muscle tightness | 1 (5.0) | 0 | 0 | 0 |
Chills | 1 (5.0) | 0 | 2 (2.2) | 0 |
Infusion-related reaction | 1 (5.0) | 0 | 6 (6.7) | 1 (1.1) |
ALT increased | 1 (5.0) | 0 | 3 (3.4) | 2 (2.2) |
Hyperphosphatemia | 1 (5.0) | 0 | 0 | 0 |
Cough | 1 (5.0) | 0 | 4 (4.5) | 0 |
Dermatitis acneiform | 1 (5.0) | 0 | 0 | 0 |
Photosensitivity reaction | 1 (5.0) | 0 | 0 | 0 |
Pneumonitis | 0 | 0 | 5 (5.6) | 2 (2.2) |
Hyperthyroidism | 0 | 0 | 5 (5.6) | 0 |
There were no grade 5 treatment-related events.
ALT, alanine aminotransferase; mCRC, metastatic colorectal cancer; MSS, microsatellite stable.
Includes nine patients who crossed over from favezelimab monotherapy.
Treatment-related adverse events.