Table 2 Results of clinical trials of CD22 ADCs in B-ALL, B-cell NHL and CLL (single-agent)
Clinical trial information | Agent | Institution | Disease and patients (single agent cohort) | Prior CD19-targeted therapy | ORR(≥ CR, best response) | Veno-occlusive disease | Median PFS | Median OS |
|---|---|---|---|---|---|---|---|---|
Phase 1 NCT00717925 [52] | Inotuzumab ozogamicin | Nagoya Daini Red Cross Hospital | R/R FL 13 pts | Rituximab 100% | 85% (54%) | - | - | - |
Phase 1 [53] | Inotuzumab ozogamicin | Multicenter | R/R B-cell NHL 79 pts | - | FL (MTD): 68% (-) DLBCL (MTD): 15% (-) | 1.30% | FL: 317Â days DLBCL: 49Â days | FL: not reached DLBCL: 193Â days |
Phase 2 NCT01134575 [54] | Inotuzumab ozogamicin | MD Anderson Cancer Center | R/R B-ALL 90 pts | - | 58% (58%) | 6.7% | mDOR 7 mos | 6.2 mos |
Phase 3, 2-arm NCT01564784 (INO-VATE) | Inotuzumab ozogamicin | Multicenter | R/R B-ALL 164 pts | - | - (74%) | 14% | 5 mos | 7.7 mos |
Phase 2 NCT00868608 [57] | Inotuzumab ozogamicin | Multicenter | Refractory indolent B-NHL 81 pts | - | 67% (31%) | - | 12.7 mos | not reached |
Phase 1/2 NCT01363297 [58] | Inotuzumab ozogamicin | Multicenter | R/R B-ALL 72 pts | - | -(68%) | 5.6% | 3.9 mos | 7.4 mos |
Phase 1 EUDRA-CT 2016–000227-71 [59] | Inotuzumab ozogamicin | Multicenter | R/R B-ALL 25 pediatric pts | Blinatumomab 24% CAR-T 4% | 80% (60%) | 8% | - | DL1: 7.2 mos DL2: not reached |
Phase 2 EUDRA-CT 2016–000227-71 [60] | Inotuzumab ozogamicin | Multicenter | R/R B-ALL 28 pediatric pts | Blinatumomab 25% | 82% (82%) in 27 evaluable pts | 25% | 1-year EFS 36.7% | 1-year OS 55.1% |
Phase 2 NCT02981628 [61] | Inotuzumab ozogamicin | Multicenter | R/R B-ALL 48 pts | CAR-T 23% Blinatumomab 29% | 65% (58%) | 13% | 2-year EFS 28.6% | 2-year OS 36% |
Phase 1 NCT01209130 [62] | Pinatuzumab vedotin | Multicenter | R/R DLBCL 25 pts indolent B-cell lymphoma 38 pts CLL 10 pts | - | DLBCL: 39% (18%) indolent B-cell lymphoma: 32% (12%) CLL: 0% (0%) | - | indolent B-cell lymphoma: 7.6 mos DLBCL (PR2D): 4 mos | - |