Table 4.
Summary of hematological PI3K related adverse events across selected studies.
| Study | Population | Neutropenia * (All Grade/Grade ≥ 3) |
Anemia * (All Grade/Grade ≥ 3) | Thrombocytopenia * (All Grade/Grade ≥ 3) |
Reference |
|---|---|---|---|---|---|
| Phase 3 idelalisib + rituximab vs. rituximab (Study 116) | RR-CLL | 30.9%/28.2% | 20.9%/9.1% | all grade < 15% | [48] |
| Phase 3 idelalisib + ofatumumab vs. ofatumumab (Study 119) | RR-CLL | 36.0%/35% | 23%/14% | 14%/11% | [49] |
| Phase 3 idelalisib + BR vs. placebo + BR | RR-CLL | 64%/60% | 27%/15% | 24%/13% | [50] |
| Phase 2 idelalisib + rituximab in older patients | TN-CLL | 53%/28% | 23%/3% | 14%/2% | [52] |
| Phase 2 idelalisib + ofatumumab | TN-CLL | 46%/29% | 8%/4% | 8%/0% | [53] |
| Phase 1 Duvelisib (IPI 145 -2 trial) |
iNHL, TN CLL, RR CLL T-CL | 38.6%/20% | 24.8%/14.3% | 23.3%/14.3% | [54] |
| Phase 2, (DYNAMO trial) | iNHL | 28.7%/24.8% | 26.4%/14.7% | 18.6%/11.6% | [55] |
| Phase 3, duvelisib vs. ofatumumab (DUO trial) | RR-CLL | 33%/30% | 23%/13% | 15%/8% | [56] |
| Phase 1 umbralisib | RR CLL/SLL, RR B-NHL, RR T-NHL, RR HL | 14%/13% | 15%/9% | 10%/6% | [57] |
| Phase 1/1b umbralisib + ublituximab | RR B-NHL, RR CLL/SLL | 55%/50% | 9%/5% | 9%/0% | [58] |
| Phase 3 umbralisib + ublituximab (UNITY-CLL) | TN CLL, RR CLL | NR/30.6% | NR | NR | [59] |
* data for CLL/SLL cohort; B-NHL—B cell non-Hodgkin lymphoma; BR—bendamustine-rituximab; not reported; iNHL—indolent non-Hodgkin lymphoma; NR—not reported O—ofatumumab; R—rituximab; TN-CLL—treatment-naïve chronic lymphocytic leukemia; RR-CLL—relapsed/refractory chronic lymphocytic leukemia; T-NHL—T cell non-Hodgkin lymphoma.