Table 4.

Overview of results for primary and secondary endpoints

PFS median (95% CI), moOS median (95% CI), moORR, % (95% CI)DOR median (95% CI), mo
Placebo BID and carbo/paclitaxel (N = 53)4.2 (3.1–5.6)9.1 (5.4–12.3)32.1 (19.9–46.3)4.3 (2.8–NA)
 Squamous (n = 25)4.1 (2.8–NA)8.4 (5.0–12.9)
 Nonsquamous (n = 28)5.0 (2.8–5.7)11.1 (4.8–14.6)
Veliparib BID and carbo/paclitaxel (N = 105)5.8 (4.3–6.5)11.7 (8.8–13.7)32.4 (23.6–42.2)6.9 (4.5–7.0)
 Squamous (n = 51)6.5 (4.4–8.4)10.3 (8.3–13.2)
 Nonsquamous (n = 54)5.6 (2.8–6.4)12.8 (8.0–17.2)
HR (95%CI)
 All patients (N = 158)0.72 (0.45–1.15)0.80 (0.54–1.18)0.47 (0.16–1.42)
  Squamous (n = 76)0.54 (0.26–1.12)0.73 (0.43–1.24)
  Nonsquamous (n = 82)0.87 (0.48–1.59)0.90 (0.51–1.58)
Adjusted HRa (95% CI)
 All patients (N = 158)0.56 (0.35–0.90)0.72 (0.49–1.07)
  Squamous (n = 76)0.43 (0.20–0.94)0.70 (0.39–1.21)
  Nonsquamous (n = 82)0.73 (0.39–1.36)0.77 (0.43–1.37)
  • Abbreviation: carbo, carboplatin.

  • aHR adjusted for ECOG performance status and gender.