Table 2.
Most common any-grade TEAEs occurring in ≥10% of patients in any retifanlimab dosing cohort, and corresponding grade ≥3 TEAEs (safety-assessable population)
| Retifanlimab dosing |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Dose escalation (n = 37) |
3 mg/kg q2w (n = 134) |
375 mg q3w (n = 15) |
500 mg q4w (n = 15) |
750 mg q4w (n = 15) |
||||||
| MedDRA preferred term, n (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| Any TEAE | 37 (100) | 27 (73) | 125 (93) | 63 (47) | 14 (93) | 7 (47) | 15 (100) | 5 (33) | 14 (93) | 7 (47) |
| Fatigue | 16 (43) | 0 | 23 (17) | 1 (1) | 2 (13) | 0 | 5 (33) | 0 | 3 (20) | 0 |
| Anemia | 7 (19) | 6 (16) | 16 (12) | 3 (2) | 2 (13) | 1 (7) | 4 (27) | 1 (7) | 6 (40) | 3 (20) |
| Diarrhea | 3 (8) | 0 | 21 (16) | 1 (1) | 1 (7) | 0 | 2 (13) | 0 | 1 (7) | 0 |
| Nausea | 8 (22) | 0 | 17 (13) | 0 | 1 (7) | 0 | 1 (7) | 0 | 4 (27) | 0 |
| Abdominal pain | 1 (3) | 0 | 15 (11) | 1 (1) | 1 (7) | 1 (7) | 0 | 0 | 1 (7) | 0 |
| Constipation | 1 (3) | 0 | 15 (11) | 0 | 0 | 0 | 1 (7) | 0 | 0 | 0 |
| Hypothyroidism | 4 (11) | 0 | 13 (10) | 1 (1) | 0 | 0 | 1 (7) | 0 | 3 (20) | 0 |
| Vomiting | 7 (19) | 0 | 13 (10) | 0 | 0 | 0 | 1 (7) | 0 | 4 (27) | 0 |
| Pyrexia | 8 (22) | 0 | 12 (9) | 1 (1) | 0 | 0 | 2 (13) | 0 | 1 (7) | 0 |
| Dehydration | 7 (19) | 1 (3) | 3 (2) | 0 | 1 (7) | 0 | 1 (7) | 0 | 0 | 0 |
| Blood ALP increased | 6 (16) | 2 (5) | 3 (2) | 2 (1.5) | 3 (20) | 1 (7) | 4 (27) | 2 (13) | 2 (13) | 0 |
| Cough | 6 (16) | 0 | 10 (7.5) | 0 | 2 (13) | 0 | 1 (7) | 0 | 3 (20) | 0 |
| Decreased appetite | 6 (16) | 0 | 10 (7.5) | 0 | 1 (7) | 0 | 2 (13) | 0 | 0 | 0 |
| Arthralgia | 4 (11) | 0 | 5 (4) | 0 | 0 | 0 | 1 (7) | 0 | 3 (20) | 0 |
| Hypertension | 4 (11) | 2 (5) | 3 (2) | 1 (1) | 0 | 0 | 0 | 0 | 0 | 0 |
| Pruritus | 4 (11) | 0 | 9 (7) | 0 | 2 (13) | 0 | 1 (7) | 0 | 2 (13) | 0 |
| Tumor flare | 4 (11) | 0 | 1 (1) | 0 | 2 (13) | 0 | 0 | 0 | 1 (7) | 0 |
| Tumor pain | 4 (11) | 1 (3) | 0 | 0 | 3 (20) | 2 (13) | 2 (13) | 0 | 1 (7) | 0 |
| Urinary tract infection | 4 (11) | 1 (3) | 11 (8) | 3 (2) | 1 (7) | 0 | 0 | 0 | 0 | 0 |
| ALT increased | 0 | 0 | 7 (5) | 1 (1) | 2 (13) | 0 | 0 | 0 | 2 (13) | 0 |
| Amylase increased | 0 | 0 | 3 (2) | 3 (2) | 2 (13) | 2 (13) | 0 | 0 | 0 | 0 |
| AST increased | 2 (5) | 1 (3) | 8 (6) | 3 (2) | 3 (20) | 0 | 1 (7) | 0 | 2 (13) | 0 |
| Blood bilirubin increased | 3 (8) | 2 (5) | 4 (3) | 0 | 2 (13) | 0 | 1 (7) | 1 (7) | 1 (7) | 1 (7) |
| Dyspnea | 1 (3) | 0 | 13 (10) | 3 (2) | 2 (13) | 1 (7) | 0 | 0 | 0 | 0 |
| Gastritis | 1 (3) | 0 | 2 (1.5) | 0 | 2 (13) | 0 | 1 (7) | 0 | 0 | 0 |
| Hypertriglyceridemia | 0 | 0 | 2 (1.5) | 1 (1) | 0 | 0 | 0 | 0 | 2 (13) | 1 (7) |
| Hypomagnesemia | 0 | 0 | 5 (4) | 0 | 2 (13) | 0 | 2 (13) | 0 | 1 (7) | 0 |
| Influenza-like illness | 3 (8) | 0 | 3 (2) | 0 | 2 (13) | 0 | 1 (7) | 0 | 1 (7) | 0 |
| Musculoskeletal pain | 2 (5) | 0 | 3 (2) | 0 | 0 | 0 | 1 (7) | 0 | 2 (13) | 0 |
| Pain in extremity | 3 (8) | 0 | 9 (7) | 1 (1) | 2 (13) | 0 | 1 (7) | 0 | 1 (7) | 0 |
| Rash | 2 (5) | 0 | 10 (7.5) | 0 | 0 | 0 | 1 (7) | 0 | 2 (13) | 0 |
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities; q2w, every 2 weeks; q3w, every 3 weeks; q4w, every 4 weeks; TEAE, treatment-emergent adverse event.