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Veliparib + CHEMO improves ORR but not PFS/OS in

platinum-naive mBRCA MBC

Han H. SABCS 2016

Veliparib + Carbo-Taxol

Placebo + Carbo-Taxol

gBRCAm MBC

<2 previous lines

No prior platinum

Veliparib + TMZ

1:1:1

N=290

San Antonio Breast Cancer Symposium, December 6 - 10, 2016

Progression-Free Survival

Months Since Randomization

WƌŽďĂďŝůŝƚLJ ŽĨ

Progression-Free Survival

Number at risk

Placebo + C/P

Veliparib + C/P

98

95

82

80

61

60

35

38

20

22

8

13

4

4

0

2

0

1

Placebo + C/P

Veliparib + C/P

0.0

0.4

0.8

0.2

0.6

1.0

0

4

8

12

16

20

24

28

32

Median (95% CI) PFS, Veliparib + TMZ: 7.4 (5.9–8.5) months; HR = 1.858 (1.278–2.702), P = 0.001. (SABCS

program number: P4-22-02)

Placebo +

C/P

N = 98

Veliparib +

C/P

N = 95

HR

P

value

*

Median PFS,

months (95%

CI)

12.3

(9.3–14.5)

14.1

(11.5–16.2)

0.789

(0.536–

1.162)

0.231

TMZ/Vel was inferior

Placebo + C/P

N = 98

Veliparib + C/P

N = 95

ORR

61.3%

77.8%