Table 1.
Outcomes With Ibrutinib: Overall, by Best Response, and by Prior LOT
| Endpoint | Overall | Prior Lines of Treatment | |
|---|---|---|---|
| (N = 370) | 1 | >1 | |
| (n = 99) | (n = 271) | ||
| PFS, median (95% CI), mo | 12.5 (9.8-16.6) | 25.4 (17.5-51.8) | 10.3 (8.1-12.5) |
| Patients with CR (n = 102) | 68.5 (51.7–NE) | NR (38.0–NE) | 67.7 (41.7–NE) |
| Patients with PR (n = 156) | 12.6 (10.3–16.6) | 24.2 (13.9–36.5) | 10.5 (8.3–12.9) |
| Overall response rate, n (%) | 258 (69.7) | 77 (77.8) | 181 (66.8) |
| CR | 102 (27.6) | 37 (37.4) | 65 (24.0) |
| PR | 156 (42.2) | 40 (40.4) | 116 (42.8) |
| SD | 43 (11.6) | 11 (11.1) | 32 (11.8) |
| PD | 56 (15.1) | 8 (8.1) | 48 (17.7) |
| NE/UN | 8 (2.2) | 1 (1.0) | 7 (2.6) |
| Missing | 5 (1.4) | 2 (2.0) | 3 (1.1) |
| DOR, median (95% CI), mo | 21.8 (17.2–26.4) | 35.6 (23.2–66.5) | 16.6 (12.9–21.3) |
| Patients with CR (n = 102) | 66.4 (49.5–NE) | NR (35.6–NE) | 65.6 (40.0–NE) |
| Patients with PR (n = 156) | 10.3 (6.6–14.8) | 22.1 (10.6–34.4) | 8.3 (6.2–10.8) |
| OS, median (95% CI), mo | 26.7 (22.5–38.4) | 61.6 (36.0–NE) | 22.5 (16.2–26.7) |
| Patients with CR (n = 102) | NR (NE–NE) | NR (74.3–NE) | NR (NE–NE) |
| Patients with PR (n = 156) | 23.6 (20.7–32.2) | 36.0 (21.8–55.6) | 22.6 (17.2–26.9) |
CI = confidence interval; CR = complete response; DOR = duration of response; LOT = line of treatment; NE = not estimable; NR = not reached; ORR = overall response rate; OS = overall survival; PFS = progression-free survival; PD = progressive disease; PR = partial response; SD = stable disease; UN = unknown.