Phase III MONALEESA-2
PFS (Investigator
Assessment)
Ribociclib + Let
n=334
Placebo + Let
n=334
Number of events, n (%)
93 (28)
150 (45)
Median PFS, months
(95% CI)
NR
(19.3–NR)
14.7
(13.0–16.5)
Hazard ratio (95% CI)
0.556 (0.429–0.720)
One-sided p value
0.00000329
PFS results by independent central review: hazard ratio 0.592 (95% CI:
0.412–0.852; p=0.002)
No. of patients at risk
Ribociclib + Let
334
294
277
257
240
226
164
119
68
20
6
1
0
Placebo + Let
334
279
264
237
217
192
143
88
44
23
5
0
0
Probability of
Progression-free Survival (%)
0
20
40
60
80
100
0
4
8
12
16
20
24
Time (months)
Let, letrozole; NR, not reached.
Hortobagyi G, et al. NEJM 2016
