Table 2.
Efficacy data by tumor type, by RECIST v1.1
| GC/GEJ | ESCC | BTC | |
|---|---|---|---|
| EEAS, n | (n = 19) | (n = 20) | (n = 18) |
| Best overall response, n (%) | |||
| Complete response | 0 | 1 (5.0) | 0 |
| Partial response | 6 (31.6) | 5 (25.0) | 2 (11.1) |
| Stable disease | 9 (47.4) | 6 (30.0) | 9 (50.0) |
| Disease progression | 3 (15.8) | 8 (40.0) | 7 (38.9) |
| Not evaluable | 1 (5.3) | 0 | 0 |
| Objective response rate, n (%) | 6 (31.6) | 6 (30.0) | 2 (11.1) |
| 95% CIa | 12.6 to 56.6 | 11.9 to 54.3 | 1.4 to 34.7 |
| Disease control rate, n (%)b | 15 (78.9) | 12 (60.0) | 11 (61.1) |
| 95% CIa | 54.4 to 94.0 | 36.1 to 80.9 | 35.8 to 82.7 |
| Duration of responsec | |||
| Median, months | 4.3 | 8.7 | -d |
| 95% CIc | 3.4 to NE | 2.8 to NE | 13.8 to NE |
BTC biliary tract cancer, EEAS efficacy-evaluable analysis set, ESCC esophageal squamous cell carcinoma, GC gastric, GEJ gastroesophageal junction, NE not evaluable, RECIST v1.1 Response Evaluation Criteria in Solid Tumors version 1.1
a95% CIs are based on Clopper–Pearson exact confidence interval
bDisease control rate = complete response + partial response + stable disease
cMedian and 95% CI are based on the Kaplan–Meier method
dAt data cutoff, only one patient in BTC cohort with an objective response had experienced tumor progression. The duration of response of this patient was 13.8 months