Table 4.
Key treatment-related adverse events of all grades in >20% and of grade ≥3 in >5% of patients treated with sacituzumab govitecan significantly impacted by UGT1A1 genotype.
| TRAE2, n (%) | SG (n = 243)1 | |||||
|---|---|---|---|---|---|---|
| *1/*1 wild type (n = 113) | *1/*28 heterozygous (n = 96) | *28/*28 homozygous (n = 34) | ||||
| All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
| Hematologic | ||||||
| Neutropenia3 | 76 (67) | 60 (53) | 55 (57) | 45 (47) | 24 (71) | 20 (59) |
| Anemia4 | 37 (33) | 5 (4) | 29 (30) | 6 (6) | 16 (47) | 5 (15) |
| Leukopenia5 | 18 (16) | 10 (9) | 13 (14) | 9 (9) | 8 (24) | 5 (15) |
| Lymphopenia6 | 10 (9) | 1 (1) | 5 (5) | 1 (1) | 4 (12) | 2 (6) |
| Febrile Neutropenia | 3 (3) | 3 (3) | 5 (5) | 5 (5) | 6 (18) | 6 (18) |
| Thrombocytopenia7 | 3 (3) | 0 | 6 (6) | 0 | 4 (12) | 4 (12) |
| Gastrointestinal | ||||||
| Diarrhea | 65 (58) | 11 (10) | 57 (59) | 9 (9) | 21 (62) | 5 (15) |
Assessed in the safety population of patients with UGT1A1 genotype. Shown are key TRAEs substantially impacted by the UGT1A1 *28/*28 genotype. Other TRAEs including nausea, vomiting, constipation, fatigue, alopecia, and decreased appetite were not substantially impacted.
AE adverse event, NCI CTCAE National Cancer Institute Common Terminology Criteria for AE, SG sacituzumab govitecan, TRAE treatment-related AE, UGT uridine diphosphate glucuronosyltransferase.
1Seven patients had UGT1A1 genotypes not listed in the table.
2Patients may report more than 1 event per preferred term. AEs were coded using MedDRA v22.1, and AE severity was graded per NCI CTCAE v4.03.
3Combined preferred terms of “neutropenia” and “neutrophil count decreased.”
4Combined preferred terms of “anemia” and “hemoglobin decreased.”
5Combined preferred terms of “leukopenia” and “white blood cell count decreased.”
6Combined preferred terms of “lymphopenia” and “lymphocyte count decreased.”
7Combined preferred terms of “thrombocytopenia” and “decreased platelet count.”