Idelalisib-related toxicities compared across multiple clinical trials
| . | Phase 1 . | Overall relapsed . | Upfront patients ≥65 y with rituximab . | Upfront patients ≥65 y idelalisib monotherapy . | Current trial . |
|---|---|---|---|---|---|
| Number of subjects | 54 | 760 | 64 | 41 | 24 |
| Median prior therapies | 5 (2-14) | ≥1 | 0 | 0 | 0 |
| Median age | 63 (37-82) | 66 (21-91) | 71 (65-90) | 71 (65-84) | 67 (58-85) |
| Median time on therapy (mo) | 15 (0.2-48.7) | — | 22.4 (0.8-45.8) | 9.3 (1.4-17.4) | 7.7 (0.7-16.1) |
| Any grade transaminitis | 28% | 48% | 67% | 24% | 79% |
| Grade ≥3 transaminitis | 1.9% | 14% | 23% | 22% | 54% |
| Grade ≥3 colitis/diarrhea | 5.6% | 14% | 42% | 27% | 13% |
| Any grade pneumonitis | 5.6% | 3% | 3% | 5% | 13% |
| Reference | Brown et al29 | Coutre et al4 | O’Brien et al6 | Zelenetz et al5 |
| . | Phase 1 . | Overall relapsed . | Upfront patients ≥65 y with rituximab . | Upfront patients ≥65 y idelalisib monotherapy . | Current trial . |
|---|---|---|---|---|---|
| Number of subjects | 54 | 760 | 64 | 41 | 24 |
| Median prior therapies | 5 (2-14) | ≥1 | 0 | 0 | 0 |
| Median age | 63 (37-82) | 66 (21-91) | 71 (65-90) | 71 (65-84) | 67 (58-85) |
| Median time on therapy (mo) | 15 (0.2-48.7) | — | 22.4 (0.8-45.8) | 9.3 (1.4-17.4) | 7.7 (0.7-16.1) |
| Any grade transaminitis | 28% | 48% | 67% | 24% | 79% |
| Grade ≥3 transaminitis | 1.9% | 14% | 23% | 22% | 54% |
| Grade ≥3 colitis/diarrhea | 5.6% | 14% | 42% | 27% | 13% |
| Any grade pneumonitis | 5.6% | 3% | 3% | 5% | 13% |
| Reference | Brown et al29 | Coutre et al4 | O’Brien et al6 | Zelenetz et al5 |