Table 2.
Frequent (in ≥3 patients) treatment-emergent and treatment-related adverse events.
| Chondrosarcomaa (n = 35) | Other tumors (n = 114) | All patients (N = 149) | ||||
|---|---|---|---|---|---|---|
| Preferred term, n (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| ≥1 TEAE | 7 (20.0) | 2 (5.7) | 62 (54.4) | 16 (14.0) | 69 (46.3) | 18 (12.1) |
| Fatigue | 2 (5.7) | 0 | 26 (22.8) | 2 (1.8) | 28 (18.8) | 2 (1.3) |
| Alanine aminotransferase increased | 4 (11.4) | 0 | 12 (10.5) | 6 (5.3) | 16 (10.7) | 6 (4.0) |
| Nausea | 1 (2.9) | 0 | 12 (10.5) | 1 (0.9) | 13 (8.7) | 1 (0.7) |
| Aspartate aminotransferase increased | 3 (8.6) | 0 | 10 (8.8) | 4 (3.5) | 13 (8.7) | 4 (2.7) |
| Diarrhea | 0 | 0 | 9 (7.9) | 3 (2.6) | 9 (6.0) | 3 (2.0) |
| Pyrexia | 0 | 0 | 6 (5.3) | 1 (0.9) | 6 (4.0) | 1 (0.7) |
| Blood alkaline phosphate increased | 1 (2.9) | 0 | 4 (3.5) | 1 (0.9) | 5 (3.4) | 1 (0.7) |
| Constipation | 0 | 0 | 4 (3.5) | 0 | 4 (2.7) | 0 |
| Vomiting | 0 | 0 | 4 (3.5) | 1 (0.9) | 4 (2.7) | 1 (0.7) |
| Blood bilirubin increased | 2 (5.7) | 1 (2.9) | 2 (1.8) | 0 | 4 (2.7) | 1 (0.7) |
| Thrombocytopenia | 0 | 0 | 3 (2.6) | 1 (0.9) | 3 (2.0) | 1 (0.7) |
| Headache | 0 | 0 | 3 (2.6) | 0 | 3 (2.0) | 0 |
| Decreased appetite | 0 | 0 | 3 (2.6) | 0 | 3 (2.0) | 0 |
| Alopecia | 0 | 0 | 3 (2.6) | 0 | 3 (2.0) | 0 |
| Infusion-related reaction | 0 | 0 | 3 (2.6) | 1 (0.9) | 3 (2.0) | 1 (0.7) |
Note: TEAEs were recorded using MedDRA preferred terms and graded according to CTCAE v5.0. Related AEs are those considered to be possibly, probably, or likely/certain to be related to INBRX-109 by the principal investigator. AEs are presented based on descending frequency in any-grade AEs seen in all patients. Data cutoff: May 26, 2022.
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent AE.
aIncludes 1 patient from dose-escalation cohort A4 (INBRX-109 10 mg/kg), 22 patients from dose-expansion cohort B4 (INBRX-109 3 mg/kg), and 12 patients from dose-expansion cohort B6 (IDH1/IDH2-mutant chondrosarcoma; INBRX-109 3 mg/kg).