Table 2:
Efficacy Analysis by Treatment Groups*
| Group 1 n=14 | Group 2 n=29 | Group 3 n=28 | Group 4 n=30 | |
|---|---|---|---|---|
|
CBR, % 95% CI |
7% (0.2–34%) | 17 % (5.8–36%) | 21% (8.3–41%) | 23% (9.9–42%) |
|
Median PFS, months 95% CI |
3.5 (1.2–14) | 2.6 (2–4) | 3.5 (2.6–4.8) | 4.9 (2.7–6.9) |
|
PFS rate at 6 months 95% CI |
40% (19–60%) | 23% (9.5–39%) | 21% (8.7–38%) | 43% (26–60%) |
|
DOR, months 95% CI |
6.5 (2.2–NE) | 5.6 (2.1–15) | 3.4 (2.4–8.3) | 3.2 (2.3–6.4) |
|
Median OS, years 95% CI |
2.9 (1.3–5.7) | 2.5 (2–3) | 4.1 (2.9–5.3) | 4.5 (3.4–6.9) |
|
3-year OS rate, % 95% CI |
48% (20–71%) | 32% (15–51%) | 67% (47–82%) | 77% (57–88%) |
group is defined as the number of prior lines of treatment: (1) one prior line of therapy, (2) two prior lines of therapy, (3) three prior lines of therapy, and (4) ≥ four lines of therapy.
CBR, clinical benefit rate; PFS, progression-free survival; DOR, duration of response; OS, overall survival; CI, confidence interval; NE, not estimable