Table 2.
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.