Table 3.

Efficacy

Rilotumumab (15 mg/kg) + MP (n = 45)Rilotumumab (7.5 mg/kg) + MP (n = 48)All rilotumumab + MP (n = 93)Placebo + MP (n = 49)
OSa
 OS events, n (%)27 (60)32 (67)59 (63)29 (59)
 Median OS, mo (80% CI)13.4 (11.2–15.3)11.6 (8.6–15.2)12.2 (11.1–13.9)11.1 (9.0–12.7)
  Stratified HRb (80% CI)0.95 (0.67–1.36)1.26 (0.90–1.77)1.10 (0.82–1.48)
  P valuec0.8590.3770.673
PFSd
 PFS events, n (%)40 (89)41 (85)81 (87)44 (90)
  Soft tissue12 (27)9 (19)21 (23)17 (35)
  PSA27 (60)24 (50)51 (55)20 (41)
  Bone15 (33)8 (17)23 (25)11 (22)
  Symptomatic deterioration11 (24)12 (25)23 (25)15 (31)
  Death27 (60)32 (67)59 (63)29 (59)
 Median PFS, mo (80% CI)2.8 (2.7–3.3)3.6 (2.9–4.5)3.0 (2.8–3.6)2.9 (2.8–3.6)
  Stratified HRb (80% CI)1.12 (0.83–1.51)0.90 (0.67–1.21)1.02 (0.79–1.31)
  P valuec0.6190.6350.940
PSA response
 Responders, n (%)5 (11)5 (10)10 (11)7 (14)
Objective tumor response
 Patients with measurable disease, n (%)25 (56)27 (56)52 (56)28 (57)
Best overall response, n (%)
  Confirmed complete response0 (0)0 (0)0 (0)0 (0)
  Confirmed partial response0 (0)0 (0)0 (0)0 (0)
  SD6 (24)13 (48)19 (37)12 (43)
  PD11 (44)6 (22)17 (33)11 (39)

NOTE: Intention-to-treat analysis set.

  • aDefined as the time from randomization to death.

  • bRelative to placebo + MP.

  • cStratified log-rank test.

  • dDefined as the time from randomization to disease progression (including soft tissue, bone scan, and PSA PD, or symptomatic deterioration) or death, whichever occurred first.