Phosphatidylinositol 3-Kinase Inhibition by Copanlisib in Relapsed or Refractory Indolent Lymphoma
Phase 2N = 142
- Population
- Relapsed or refractory indolent lymphoma after two or more lines of therapy (histologies combined in the abstract; follicular lymphoma not reported separately there).
- Design
- Phase II study in 142 patients with relapsed or refractory indolent lymphoma after two or more lines of therapy: copanlisib 60 mg intravenously on days 1, 8 and 15 of a 28-day cycle. Primary endpoint: objective response rate.
- Primary endpoint
- ORR
- Arms
- Copanlisib (experimental, n = 142): Copanlisib 60 mg intravenously on days 1, 8 and 15 of a 28-day cycle
- People
- Dreyling M
Show the numbers
| Endpoint | Analysis | Copanlisib | Control | Effect |
|---|---|---|---|---|
| ORRAll 142 enrolled patients | primaryDreyling 2017 | 59% | — | 84 of 142 patients responded; 12% achieved a complete response. The abstract does not break the response rate down by histology. |
| PFSAll 142 enrolled patients | primaryDreyling 2017 | median 11.2 months | — | Median duration of response was 22.6 months. Secondary endpoint. |
| Endpoint | Analysis | Copanlisib | Control | Effect |
|---|---|---|---|---|
| ORRAll 142 enrolled patients | primaryDreyling 2017 | 59% | — | 84 of 142 patients responded; 12% achieved a complete response. The abstract does not break the response rate down by histology. |
| PFSAll 142 enrolled patients | primaryDreyling 2017 | median 11.2 months | — | Median duration of response was 22.6 months. Secondary endpoint. |
- Copanlisib (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Copanlisib |
|---|---|
| 0 | 100.0% |
| 7 | 64.8% |
| 14 | 42.0% |
| 21 | 27.3% |
| 28 | 17.7% |