TABLE 5.
Efficacy outcomes
| Characteristics | Cohort | Overall N = 43 | |||
|---|---|---|---|---|---|
| ACC n = 12 | GC n = 10 | EGC n = 11 | SCLC n = 10 | ||
| BOR, n (%) | |||||
| PR | 2 (16.7) | 2 (20.0) | 1 (9.1) | 0 | 5 (11.6) |
| SD | 9 (75.0) | 6 (60.0) | 5 (45.5) | 6 (60.0) | 26 (60.5) |
| PD | 1 (8.3) | 2 (20.0) | 5 (45.5) | 4 (40.0) | 12 (27.9) |
| ORR a , n (%) | 2 (16.7) | 2 (20.0) |
1 (9.1) |
0 |
5 (11.6) |
| 95% CI b | 2.1–48.4 | 2.5–55.6 |
0.2–41.3 |
0.0–30.8 |
3.9–25.1 |
|
DCR c , n (%) |
11 (91.7) |
8 (80.0) |
6 (54.5) |
6 (60.0) |
31 (72.1) |
|
95% CI b |
61.5–99.8 |
44.4–97.5 |
23.4–83.3 |
26.2–87.8 |
56.3–84.7 |
|
CBR d , n (%) |
8 (66.7) |
5 (50.0) |
2 (18.2) |
1 (10.0) |
16 (37.2) |
|
95% CI b |
34.9–90.1 |
18.7–81.3 |
2.3–51.8 |
0.3–44.5 |
23.0–53.3 |
|
Durable SD rate e , n (%) |
6 (50.0) |
3 (30.0) |
1 (9.1) |
1 (10.0) |
11 (25.6) |
|
95% CI b |
21.1–78.9 |
6.7–65.2 |
0.2–41.3 |
0.3–44.5 |
13.5–41.2 |
|
Median PFS f , months (95% CI) |
16.6 (4.2–NE) |
3.5 (0.4–6.6) |
2.8 (1.2–4.4) |
2.4 (1.0–2.9) |
4.2 (2.6–5.4) |
|
Quartile 1 (95% CI) |
11.1 (1.2–16.6) |
2.6 (0.4–4.3) |
1.2 (1.2–2.8) |
1.3 (1.0–2.6) |
1.4 (1.2–2.7) |
|
Quartile 3 (95% CI) |
NE (11.3–NE) |
6.6 (2.8–NE) |
4.4 (1.4–5.4) |
2.9 (2.3–11.1) |
11.1 (5.3–16.8) |
Abbreviations: ACC, adenoid cystic carcinoma; BOR, best overall response; CBR, clinical benefit rate; CI, confidence interval; CR, complete response; DCR, disease control rate; EGC, esophageal cancer; GC, gastric cancer; NE, not estimable; ORR, objective response rate; PD, progressive disease; PFS, progression‐free survival; PR, partial response; SCLC, small cell lung cancer; SD, stable disease.
Proportion of patients with CR + PR.
Calculated using the Clopper‐Pearson method.
Proportion of patients with CR + PR + SD (SD ≥5 weeks).
CR + PR + durable SD (SD ≥23 weeks).
Proportion of patients with duration of SD ≥23 weeks.
Calculated using Kaplan–Meier estimates and Greenwood Formula.