Table 2.
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 |
---|---|---|---|---|
Best overall response, n (%) (95% CI) | ||||
CR | 0 (0.0) (0.0, 6.7) | 1 (2.2) (0.1, 11.5) | 0 (0.0) (0.0, 8.6) | 0 (0.0) (0.0, 11.9) |
PR | 6 (11.3) (4.3, 23.0) | 5 (10.9) (3.6, 23.6) | 5 (12.2) (4.1, 26.2) | 2 (6.9) (0.8, 22.8) |
SD | 33 (62.3) (47.9, 75.2) | 24 (52.2) (36.9, 67.1) | 17 (41.5) (26.3, 57.9) | 13 (44.8) (26.4, 64.3) |
PD | 9 (17.0) (8.1,29.8) | 15 (32.6) (19.5,48.0) | 15 (36.6) (22.1,53.1) | 11 (37.9) (20.7,57.7) |
ORR (CR/PR), n (%) (95% CI) | 6 (11.3) (4.3, 23.0) | 6 (13.0) (4.9, 26.3) | 5 (12.2) (4.1, 26.2) | 2 (6.9) (0.8, 22.8) |
DCR (CR+PR+Stable disease persisting≥4 months), n (%) (95% CI) | 24 (45.3) (31.6, 59.6) | 15 (32.6) (19.5, 48.0) | 13 (31.7) (18.1,48.1) | 9 (31. 0) (15.3, 50.8) |
DoR, median months (95% CI); patients censored (%)a | 8.6 (5.6, NE); 0 (0.0) | 3.8 (2.8, NE); 1 (16.7) | 5.6 (3.7, NE); 0 (0.0) | 5.3 (5.1, NE); 0 (0.0) |
PFS, median months (95% CI); patients censored (%) | 3.9 (3.7, 5.7); 6 (11.3) | 3.7 (3.1, 4.7); 4 (8.7) | 3.6 (1.9, 3.9); 4 (9.8) | 3.7 (1.8, 4.7); 4 (13.8) |
OS, median months (95% CI); Patients censored (%) | 13.0 (7.5, 19.3); 18 (34.0) | 14.3 (11.8, 16.5); 12 (26.1) | 11.1 (7.2, 16.4); 12 (29.3) | 8.2 (6.2, 11.9); 4 (13.8) |
The total ‘N’ varied (N=19); Cohort 1 n=6; Cohort 2 n=6; Cohort 3 n=5; Cohort 4 n=2
Abbreviations: BRCA, breast cancer gene; CI, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; N = number of patients in the population; n = number of patients in the specified category; NE = not evaluable; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease