Relevant phase 3 clinical trials in CLL
| Trial . | Regimens compared . | ORR, % . | PFS . | OS . | Results . |
|---|---|---|---|---|---|
| CLL831 | FC | 80 | Median, 32.9 mo | Median, 86 mo | FCR is superior to FC in terms of PFS |
| FCR | 90 | Median, 56.8 mo | Median, not reached | FCR is superior to FC in terms of PFS | |
| CLL1021 | FCR | 95 | Median, 55.2 mo | 3-y, 91% | BR is inferior to FCR in terms of PFS |
| BR | 96 | Median, 41.7 mo | 3-y, 92% | ||
| CLL1120 | Ch | 65.7 | Median, 11.1 mo | NR | ChO is superior to Ch and ChR in terms of PFS and OS |
| ChR | 31.4 | Median, 15.4 mo | NR | ||
| ChO | 77.3 | Median, 29.2 mo | NR | ||
| RESONATE 226 | Ch | 35 | 24-mo, 34% | 24-mo, 84% | Ibrutinib is superior to Ch in terms of PFS and OS |
| Ibrutinib | 92 | 24-mo, 89% | 24-mo, 95% | ||
| E191234 | IR | 96 | 3-y, 89% | 3-y, 99% | IR is superior to FCR in terms of PFS and OS |
| FCR | 81 | 3-y, 73% | 3-y, 92% | ||
| A04120228 | BR | 81 | 2-y, 74% | 2-y, 95% | Ibrutinib and IR are superior to BR in terms of PFS, IR is no more effective than ibrutinib in terms of PFS |
| Ibrutinib | 93 | 2-y, 87% | 2-y, 90% | ||
| IR | 94 | 2-y, 88% | 2-y, 94% | ||
| iLLUMINATE30 | ChO | 73 | 30-mo, 31% | 30-mo, 85% | IO is superior to ChO in terms of PFS |
| IO | 88 | 30-mo, 79% | 30-mo, 86% | ||
| CLL1435 | ChO | 71.3% | 2-y, 64.1% | 2-y, 93.3% | VO is superior to ChO in terms of PFS |
| VO | 84.7% | 2-y, 88.2% | 2-y, 91.8% |
| Trial . | Regimens compared . | ORR, % . | PFS . | OS . | Results . |
|---|---|---|---|---|---|
| CLL831 | FC | 80 | Median, 32.9 mo | Median, 86 mo | FCR is superior to FC in terms of PFS |
| FCR | 90 | Median, 56.8 mo | Median, not reached | FCR is superior to FC in terms of PFS | |
| CLL1021 | FCR | 95 | Median, 55.2 mo | 3-y, 91% | BR is inferior to FCR in terms of PFS |
| BR | 96 | Median, 41.7 mo | 3-y, 92% | ||
| CLL1120 | Ch | 65.7 | Median, 11.1 mo | NR | ChO is superior to Ch and ChR in terms of PFS and OS |
| ChR | 31.4 | Median, 15.4 mo | NR | ||
| ChO | 77.3 | Median, 29.2 mo | NR | ||
| RESONATE 226 | Ch | 35 | 24-mo, 34% | 24-mo, 84% | Ibrutinib is superior to Ch in terms of PFS and OS |
| Ibrutinib | 92 | 24-mo, 89% | 24-mo, 95% | ||
| E191234 | IR | 96 | 3-y, 89% | 3-y, 99% | IR is superior to FCR in terms of PFS and OS |
| FCR | 81 | 3-y, 73% | 3-y, 92% | ||
| A04120228 | BR | 81 | 2-y, 74% | 2-y, 95% | Ibrutinib and IR are superior to BR in terms of PFS, IR is no more effective than ibrutinib in terms of PFS |
| Ibrutinib | 93 | 2-y, 87% | 2-y, 90% | ||
| IR | 94 | 2-y, 88% | 2-y, 94% | ||
| iLLUMINATE30 | ChO | 73 | 30-mo, 31% | 30-mo, 85% | IO is superior to ChO in terms of PFS |
| IO | 88 | 30-mo, 79% | 30-mo, 86% | ||
| CLL1435 | ChO | 71.3% | 2-y, 64.1% | 2-y, 93.3% | VO is superior to ChO in terms of PFS |
| VO | 84.7% | 2-y, 88.2% | 2-y, 91.8% |
BR, bendamustine/rituximab; Ch, chlorambucil; ChO, chlorambucil/obinutuzumab; ChR, chlorambucil/rituximab; FC, fludarabine/cyclophosphamide; FCR, fludarabine/cyclophosphamide/rituximab; IO, ibrutinib/obinutuzumab; IR, ibrutinib/rituximab; iwCLL, International Working Group on CLL; NR, not reported; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.