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Primary endpoint: PFS (investigator-assessed)
11
The hazard ratio of 0.593 corresponds to a 41% reduction in risk of progression in the ribociclib vs placebo arm
No. at risk
Ribociclib + fulvestrant
Placebo + fulvestrant
484
242
403
195
365
168
347
156
324
144
305
134
282
116
259
106
235
95
155
53
78
27
52
14
13
4
0
0
PFS (investigator
assessment)
Ribociclib +
fulvestrant
n=484
Placebo +
fulvestrant
n=242
Events, n (%)
210 (43.4)
151 (62.4)
Median PFS,
months
(95% CI)
20.5
(18.5–23.5)
12.8
(10.9–16.3)
Hazard ratio (95%
CI)
0.593 (0.480–0.732)
One-sided p value
0.00000041
Time (months)
Probability of PFS (%)
100
80
60
40
20
0
0
2
4
6
8
10 12 14 16 18 20 22 24 26
CI, confidence interval.