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. 2021 Jun 15;27(18):4983–4993. doi: 10.1158/1078-0432.CCR-21-0748

Table 2.

Exposure to and activity of crossover veliparib monotherapy.

Progression on carboplatin in the blinded studya Platinum-free interval at crossover veliparib monotherapy start
Crossover veliparib monotherapy Yes No <180 days ≥180 days
(N = 75) (n = 37) (n = 38) (n = 53) (n = 22)
Mean exposure to crossover veliparib monotherapy, days (range) 154 (2–966) 121.9 (2–539) 196.3 (5–967) 133.7 (2–680) 222.1 (5–967)
Best responseb, n/N (%)
 Complete response 0 0 0 0 0
 Partial response 8/50 (16) 3/27 (11.1) 5/23 (21.7) 5/37 (13.5) 3/13 (23.1)
Clinical benefit rate at 24 weeksc, % (95% CI) 30.5 (21.9–39.5) 27.3 (13.6–43.0) 46.9 (29.0–62.9) 30.0 (17.7–43.3) 55.0 (29.8–74.5)
Median progression-free survivald, months (95% CI) 2.1 (2.1–4.4) 2.1 (1.9–3.7) 4.4 (2.1–8.2) 2.1 (2.0–4.1) 8.2 (1.9–NR)

Abbreviation: NR, not reached.

aProgressive disease per protocol indicated as reason for carboplatin discontinuation during placebo plus carboplatin/paclitaxel treatment. All patients receiving crossover veliparib monotherapy were required to have progressed on placebo plus carboplatin/paclitaxel; however, placebo, carboplatin, and paclitaxel could be discontinued independently prior to progression.

bIncludes patients with at least one measurable lesion at baseline.

cFrom Kaplan–Meier estimates. Clinical benefit rate is defined as the progression-free rate at 24 weeks (168 days) estimated using Kaplan–Meier methodology.

dMedian progression-free survival is evaluated from first day of crossover treatment.