Table 3.
Treatment-related adverse events related to study treatment occurring in >20% of the population
| Parameter | Cohort 1: Platinum resistant, BRCA-wildtype with ≥3 prior lines of therapy N=53 | Cohort 2: Platinum resistant, BRCA-wildtype with <3 prior lines of therapy N=46 | Cohort 3: Platinum resistant, BRCA-mutated with prior PARP inhibitor therapy N=41 | Cohort 4: Platinum refractory with any number of prior lines of therapy N=29 | All cohorts N=169 | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| All | G3/4/5* | All | G3/4/5 | All | G3/4/5 | All | G3/4/5 | All | G3/4/5 | |
| Thrombocytopenia | 24 (45.3) | 12 (22.6) | 20 (43.5) | 6 (13.0) | 19 (46.3) | 8 (19.5) | 11 (37.9) | 4 (13.8) | 74 (43.8) | 30 (17.8) |
| Neutropenia | 23 (43.4) | 19 (35.8) | 20 (43.5) | 16 (34.8) | 17 (41.5) | 17 (41.5) | 12 (41.4) | 12 (41.4) | 72 (42.6) | 64 (37.9) |
| Fatigue | 25 (47.2) | 4 (7.5) | 17 (37.0) | 0 (0.0) | 17 (41.5) | 2 (4.9) | 12 (41.4) | 4 (13.8) | 71 (42.0) | 10 (5.9) |
| Nausea | 17 (32.1) | 1 (1.9) | 20 (43.5) | 1 (2.2) | 11 (26.8) | 1 (2.4) | 13 (44.8) | 0 (0.0) | 61 (36.1) | 3 (1.8) |
| Anemia | 16 (30.2) | 7 (13.2) | 12 (26.1) | 1 (2.2) | 13 (31.7) | 5 (12.2) | 12 (41.4) | 5 (17.2) | 53 (31.4) | 18 (10.7) |
| Vomiting | 14 (26.4) | 2 (3.8) | 12 (26.1) | 2 (4.3) | 9 (22.0) | 2 (4.9) | 10 (34.5) | 1 (3.4) | 45 (26.6) | 7 (4.1) |
| Diarrhea | 11 (20.8) | 0 (0.0) | 13 (28.3) | 0 (0.0) | 4 (9.8) | 0 (0.0) | 6 (20.7) | 1 (3.4) | 34 (20.1) | 1 (0.6) |
Abbreviations: BRCA, breast cancer gene; G, grade.
*
The only Grade 5 AE was one patient in Cohort 1 with sepsis.