Table 4.
Tumor Response Evaluation (Investigator Assessment; Full Analysis Set With Postbaseline Tumor Assessment)
| Copanlisib Plus R-B SRI (N = 10) | Copanlisib Plus R-CHOP SRI (N = 10a) | |
|---|---|---|
| Best overall response | ||
| Complete response | 5 (50.0)b [18.7, 81.3] | 3 (30.0) [6.7, 65.2] |
| Partial response | 4 (40.0)c [12.2, 73.8] | 7 (70.0)b [34.8, 93.3] |
| Stable disease | 1 (10.0) [0.3, 44.5] | 0 [0.0, 30.8] |
| Progressive disease | 0 [0.0, 30.8] | 0 [0.0, 30.8] |
| Objective response rate | 9 (90.0) [55.5, 99.7] | 10 (100) [69.2, 100] |
Data are presented as n (%) [95% CI].
Abbreviations: CI = confidence interval; R-B = rituximab plus bendamustine; R-CHOP = rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; SRI = safety run-in.
a
11 patients were treated, but 1 patient was not included because their first postbaseline tumor assessment was reached after the data cut-off date.
b
1 patient had their first postbaseline tumor assessment outside of the protocol-required 12-week (± 1 week) assessment period.
c
2 patients had their first postbaseline tumor assessment outside of the protocol-required 12-week (± 1 week) assessment period.