Table 1.
Best Overall Response using RECIST v1.1
| Best Overall Response per RECIST v1.1b | MVA-BN-CV301/FPV-CV301 and Atezolizumab | |||
|---|---|---|---|---|
| Cohort 1 (N = 19) | Cohort 2 (N = 24) | |||
| Response (Rate), n (%) | 90% CIa | Response (Rate), n (%) | 90% CIa | |
| Subjects with Assessment | 19 | 24 | ||
| Objective Response (CR or PR) | 1 (5.3) | [0.3, 22.6] | 2 (8.3) | [1.5, 24.0] |
| Complete Response (CR) | 0 (0.0) | [0.0, 14.6] | 1 (4.2) | [0.2, 18.3] |
| Partial Response (PR) | 1 (5.3) | [0.3, 22.6] | 1 (4.2) | [0.2, 18.3] |
| Stable Disease (SD) | 5 (26.3) | [11.0, 47.6] | 3 (12.5) | [3.5, 29.2] |
| Progressive Disease (PD) | 11 (57.9) | [36.8, 77.0] | 18 (75.0) | [56.5, 88.5] |
| Not Evaluable | 2 (10.5) | [1.9, 29.6] | 1 (4.2) | [0.2, 18.3] |
CI, confidence interval; N, total number of subjects; n, number of subjects in the indicated category; RECIST, Response Evaluation Criteria In Solid Tumors.
aThe 2-sided 90% exact binomial confidence interval for the overall response rate was calculated using the Clopper-Pearson method.
bThe primary endpoint of objective response rate was the proportion of subjects in the analysis population with CR or PR based on best overall RESIST v1.1 assessment any time within the active trial phase, including any unscheduled post-intervention assessments.