Table 2 Best overall response (investigator-assessed)
Best overall responsea | Lerociclib + Fulvestrantn (%) | Placebo + Fulvestrant n (%) |
|---|---|---|
ITT population | N = 137 | N = 138 |
CR | 3 (2.2%) | 0 |
PR | 29 (21.2%) | 12 (8.7%) |
SD | 80 (58.4%) | 86 (62.3%) |
SD ≥ 6 months | 34 (24.8%) | 22 (15.9%) |
PD | 23 (16.8%) | 37 (26.8%) |
NE | 1 (0.7%) | 0 |
NA | 1 (0.7%) | 3 (2.2%) |
ORR (CR + PR) | 32 (23.4%) | 12 (8.7%) |
95% CI | 16.27%, 30.44% | 3.99%, 13.40% |
DCR (CR + PR + SD) | 112 (81.8%) | 98 (71.0%) |
95% CI | 75.28%, 88.22% | 63.44%, 78.58% |
CBR (CR + PR + SD ≥ 6 months) | 66 (48.2%) | 34 (24.6%) |
95% CI | 39.81%, 56.54% | 17.45%, 31.83% |
Measurable disease at baseline | N = 119 | N = 121 |
CR | 3 (2.5%) | 0 |
PR | 29 (24.4%) | 12 (9.9%) |
SD | 64 (53.8%) | 73 (60.3%) |
SD ≥ 6 months | 29 (24.4%) | 20 (16.5%) |
PD | 22 (18.5%) | 33 (27.3%) |
NE | 0 | 0 |
NA | 1 (0.8%) | 3 (2.5%) |
ORR (CR + PR) | 32 (26.9%) | 12 (9.9%) |
95% CI | 18.92%, 34.86% | 4.59%, 15.24% |
CBR (CR + PR + SD ≥ 6 months) | 61 (51.3%) | 32 (26.4%) |
95% CI | 42.28%, 60.24% | 18.59%, 34.30% |
