Publication date: Jun 10, 2025
Treatment options for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) patients ineligible for autologous stem cell transplant (ASCT) or chimeric antigen receptor (CAR)-T-cell therapy remain limited. The PI3K inhibitor copanlisib has shown activity as a single agent in DLBCL. This phase II, single-arm, multicentre trial evaluated copanlisib with rituximab and bendamustine (copa-BR) in ASCT- and CAR-T-ineligible R/R DLBCL. Patients received six cycles of copa-BR, followed by up to 12 cycles of copanlisib maintenance. The primary end-point was 12-month progression-free survival (PFS). Thirty-seven patients (aged 68-87 years, R/R after 1-2 prior lines) were enrolled. The overall response rate was 24. 3%, with complete responses in 13. 5%. After a median follow-up of 20 months, the 12-month PFS and overall survival rates were 25. 1% and 44. 5% respectively. Grade ≥3 toxicities included neutropenia (56. 8%), infections (27. 0%, including 6 death due to COVID-19 infection with 25% fatality) and thrombocytopenia (16. 2%). Due to limited efficacy, poor tolerability and emerging alternative treatments, the trial was terminated prematurely. Copa-BR showed limited activity and an unfavourable safety profile, discouraging further investigation of this combination in ASCT- and CAR-T-ineligible R/R DLBCL.
| Concepts | Keywords |
|---|---|
| 20months | bendamustine |
| 87years | copanlisib |
| Car | relapsed/refractory |
| Thrombocytopenia | rituximab |
| Tolerability |
Semantics
| Type | Source | Name |
|---|---|---|
| drug | DRUGBANK | Copanlisib |
| drug | DRUGBANK | Rituximab |
| drug | DRUGBANK | Bendamustine |
| disease | MESH | diffuse large B-cell lymphoma |
| disease | IDO | cell |
| disease | MESH | neutropenia |
| disease | MESH | infections |
| disease | MESH | death |
| disease | MESH | COVID-19 |
| disease | IDO | infection |
| disease | MESH | thrombocytopenia |
| disease | MESH | lymphoma |