Table 2.
Summary of efficacy outcomes from clinical studies of copanlisib in patients with aggressive lymphoma
| Study | Histology | Number of patients | ORR, % (CR; PR) | DCR, % (SD) |
|---|---|---|---|---|
| Phase I | ||||
| NCT00962611 [34] | DLBCL | 3 | 33.3 (0; 1) | 33.3 (0) |
| Phase II | ||||
| NCT01660451; part A [52] | PTCL | 17a,b | 21.4 (2; 1) | 57.1 (5) |
| DLBCL | 15 | 6.7 (0; 1) | 46.7 (6) | |
| MCL | 11 | 63.6 (2c; 5) | 63.6 (0) | |
| Transformed indolent FL | 6 | 33.3 (0; 2) | 33.3 (0) | |
| Mediastinal large B cell lymphoma | 1 | 0 | 0 | |
| FLd | 1 | 0 | 0 | |
| NCT02391116 [55] | ABC DLBCL | 19 | 31.6 (4; 2) | 52.6 (4) |
| GCB DLBCL | 30 | 13.3 (1; 3) | 40.0 (8) |
ABC activated B cell-like, CR complete response, DCR disease control rate, DLBCL diffuse large B cell lymphoma, FL follicular lymphoma, GCB germinal center B cell-like, MCL mantle cell lymphoma, ORR objective response rate, PR partial response, PTCL peripheral T cell lymphoma, SD stable disease
aIncludes three patients with anaplastic large-cell lymphoma and four patients with angioimmunoblastic T cell lymphoma
b14 patients with PTCL were evaluable for response
cIncludes two unconfirmed CRs
dGrade 3b