Table 2.
Comparison of Rates of Autoimmune Toxicity for Each Drug, Based on Lines of Prior Therapy and Duration on Inhibitor
| Drug | Disease / Study | Median Prior Tx | Median Time on Therapy | Grade 3+ Neutropenia | Grade 3+ Diarrhea/Colitis | Grade 3+ Transaminitis | Grade 3+ Rash | Grade 3+ Pneumonitis |
|---|---|---|---|---|---|---|---|---|
| Idelalisib | CLL ph 110 | 5 | 15 mos | 43% | 5.6% | 2% | 0% | 5.6% |
| CLL / NHL combined safety analysis15 | 1-2 | N.R. | 30% | 14% | 14% | 5% | 3% | |
| CLL frontline >65 + R17 | 0 | 22.4 mos | 28% | 42% | 23% | 13% | 6% | |
| CLL frontline > 6552 | 0 | 10.4 mos | 17% | 27% | 22% | 10% | 5% | |
| CLL frontline any age18 | 0 | 8.1 mos | 33% | 15% | 52% | 7% | 7% | |
| Duvelisib | CLL, Phase 131 | 4 | 6 mos | 44% | 9.1%; 5.5% colitis | 11% | 0% | 9.1% |
| CLL, Duo32 | 2 | 22.4 mos | 30% | 15%; 12% colitis | 3% | 2% | 3% | |
| NHL, Dynamo53 | 3 | 6 mos | 23% | 15% | 6% | 5% | 4% | |
| CLL, Ph 1 frontline cohort54 | 0 | 15.6 mos | 33% | 22% | 17% | 5.6% | 11% | |
| NHL, Contempo + R55 | 0 | 6.2 mos | 10.7% | 14% | 25% | 10.7% | N.R. | |
| NHL Contempo + G55 | 0 | 6.1 mos | 22.2% | 11% | 26% | 7.4% | N.R. | |
| Umbralisib | CLL / NHL, phase 137 | 3 | 4.7 mos | 13% | 3% diarrhea / 2% colitis | 3% | 4% | N.R. |
| CLL / NHL, integrated safety analysis42 | 3 | 6.5 mos | 16% | 4% diarrhea / <1% colitis | 2% | N.R. | <0.5% | |
| CLL/NHL Integrated Analysis, pts c > 6 mos exposure42 | 2 | 1.3 yrs | 9% | 8% diarrhea (includes 1 colitis) | 3% | 0% | 0.5% | |
| Copanlisib | NHL Ph 2 registration trial34 | 3 | 5.5 mos | 24% | 5% diarrhea | 2% | 1% | 1% |
| Parsaclisib | NHL, CLL44 | 3 | 4 mos | 19% | 9% | 3% | 6% | 0% |
| ME-401 | CS: CLL, FL46 | CLL 1, FL 2 | 9.8 mo | NR (<15%) | 20% | 7.5% | 10% | 12.5% |
| IS: CLL, FL46 | CLL 1, FL 2 | 4.8 mos (Ton T) | NR (<15%) | 9.7% | 3.2% | 0% | 3.2% |