Table 2 Tumor responses and survival outcomes.
Efficacy | ITT (n = 141) | A (n = 4) | B (n = 20) | C (n = 46) | D (n = 10) | E (n = 46) | F (n = 6) | G (n = 9) |
|---|---|---|---|---|---|---|---|---|
CRa, No. of patients (%) | 4 (2.8) | 0 | 0 | 2 (4.3) | 1 (10.0) | 1 (2.2) | 0 | 0 |
PRa, No. of patients (%) | 38 (27.0) | 3 (75.0) | 0 | 18 (39.1) | 1 (10.0) | 12 (26.1) | 1 (16.7) | 3 (33.3) |
SD, No. of patients (%) | 26 (18.4) | 0 | 2 (10.0) | 10 (21.7) | 1 (10.0) | 11 (23.9) | 1 (16.7) | 1 (11.1) |
PD, No. of patients (%) | 44 (31.2) | 1 (25.0) | 10 (50.0) | 9 (19.6) | 4 (40.0) | 15 (32.6) | 2 (33.3) | 3 (33.3) |
NAb, No. of patients (%) | 29 (20.6) | 0 | 8 (40.0) | 7 (14.3) | 3 (30.0) | 7 (15.2) | 2 (33.3) | 2 (22.2) |
Objective responsec | ||||||||
No. of patients | 42 | 3 | 0 | 20 | 2 | 13 | 1 | 3 |
Percentage of patients (95% CI) | 29.8 (22.4–38.1) | 75.0 (19.4–99.4) | 0 | 43.5 (28.9–58.9) | 20.0 (2.5–55.6) | 28.3 (16.0–43.5) | 16.7 (0.4–64.1) | 33.3 (7.5–70.1) |
Disease controld | ||||||||
No. of patients | 68 | 3 | 2 | 30 | 3 | 24 | 2 | 4 |
Percentage of patients (95% CI) | 48.2 (39.7–56.8) | 75.0 (19.4–99.4) | 10.0 (1.2–31.7) | 65.2 (49.8–78.6) | 30.0 (6.7–65.3) | 52.2 (36.9–67.1) | 33.3 (4.3–77.7) | 44.4 (13.7–78.8) |
Median PFS (95% CI), month | 3.4 (2.7–4.2) | 3.4 (0–7.3) | 1.9 (1.7–2.1) | 4.6 (3.4–5.9) | 2.0 (1.7–2.3) | 3.4 (1.7–5.0) | 1.2 (0–2.5) | 3.0 (2.4–3.6) |
Median OS (95% CI), month | 10.7 (9.1–12.3) | 16.7 (0–35.3) | 6.1 (2.8–9.4) | 16.1 (11.7–20.5) | 6.2 (1.9–10.5) | 10.1 (3.8–16.3) | 2.7 (0–17.0) | 4.5 (2.4–6.6) |