Table 2.

PTEN loss and nonloss subpopulations by the four PTEN diagnostic assays tested for (A) rPFS and (B) OS

A
Primary analysisExploratory analysis
ICR IHCVentana IHCFISHNGS
PTEN lossPTEN nonlossPTEN lossPTEN nonlossPTEN lossPTEN nonlossPTEN lossPTEN nonloss
400 mg ipatasertib + abiraterone
Patients, n2532262228381521
Patients with events, n (%)15 (60.0)20 (62.5)16 (61.5)14 (63.6)15 (53.6)25 (65.8)7 (46.7)14 (66.7)
rPFS, median months
 Ipatasertib11.57.511.07.513.76.513.87.4
 Placebo4.65.64.65.76.55.66.24.5
rPFS HR0.390.840.500.740.670.770.240.52
90% CI0.22–0.700.51–1.370.29–0.870.41–1.320.36–1.240.50–1.200.10–0.600.25–1.02
200 mg ipatasertib + abiraterone
Patients, n2527311622471316
Patients with events, n (%)16 (64.0)20 (74.1)21 (67.7)12 (75.0)15 (68.2)31 (66.0)9 (69.2)10 (62.5)
rPFS, median months
 Ipatasertib11.14.68.56.410.56.78.38.6
 Placebo4.65.64.65.76.55.66.24.5
rPFS HR0.461.130.661.040.870.740.550.53
90% CI0.25–0.830.69–1.850.39–1.110.57–1.920.47–1.610.49–1.130.24–1.270.25–1.13
Placebo + abiraterone
Patients, n2135252621401113
Patients with events, n (%)18 (85.7)26 (74.3)20 (80.0)19 (73.1)14 (66.7)31 (77.5)10 (90.9)11 (84.6)
B
Primary analysisExploratory analysis
ICR IHCVentana IHCFISHNGS
PTEN lossPTEN nonlossPTEN lossPTEN nonlossPTEN lossPTEN nonlossPTEN lossPTEN nonloss
Ipatasertib 400 mg + abiraterone
Patients, n2532262228381521
Patients with events, n (%)9 (36.0)9 (28.1)10 (38.5)5 (22.7)9 (32.1)15 (39.5)5 (33.3)7 (33.3)
OS, median months
 Ipatasertib19.1517.2219.1515.5719.1517.22NE19.15
 Placebo14.7513.7712.8113.7718.4311.8314.7513.77
OS HR0.620.560.650.540.890.620.440.54
90% CI(0.29–1.33)(0.28–1.13)(0.33–1.28)(0.22–1.29)(0.40–1.99)(0.35–1.08)(0.15–1.29)(0.21–1.40)
Ipatasertib 200 mg + abiraterone
Patients, n2527311622471316
Patients with events, n (%)8 (32.0)13 (48.1)13 (41.9)7 (43.8)10 (45.5)20 (42.6)6 (46.2)7 (43.8)
OS, median months
 IpatasertibNE10.68NE13.4413.4416.36NE13.44
 Placebo14.7513.7712.8113.7718.4311.8314.7513.77
OS HR0.641.190.830.981.70.721.130.79
90% CI(0.30–1.37)(0.64–2.22)(0.44–1.56)(0.45–2.14)(0.77–3.73)(0.43–1.21)(0.43–2.93)(0.31–1.97)
Placebo + abiraterone
Patients, n2135252621401113
Patients with events, n (%)12 (57.1)16 (45.7)14 (56.0)13 (50.0)8 (38.1)22 (55.0)6 (54.5)6 (46.2)

Abbreviation: NE, not estimable.