Immunotherapy studies in R/R BCP-ALL
| Reference . | Study . | Eligibility . | Patients, N . | Median age (y) . | Prior alloHSCT . | ORR . | Molecular response . | Bridge to alloHSCT . | OS estimate or median . |
|---|---|---|---|---|---|---|---|---|---|
| Multicenter antibody-based studies | |||||||||
| Kantarjian et al, 2016122 | INO phase 3 (INO-VATE) | ≥18 years R/R CD22+ ALL | 109 (67% salvage 1) | 47 | 16% | 81% | 63% | 40% | 7.7 mo |
| Topp et al, 2015191 | Blinatumomab phase 2 | ≥18 years Ph-neg R/R ALL CR1 <12 months | 189 (61% salvage 1) | 36 | 34% | 43% | 35% | 40% | 6.1 months |
| Kantarjian et al, 2017192 | Blinatomomab phase 3 (TOWER) | ≥18 years Ph-neg R/R ALL CR1 <12 months | 271 (42% salvage 1) | 37 | 35% | 44% | 36% | 14% | 7.7 months |
| Gokbuget et al, 201867 | Blinatumomab phase 2 (BLAST) | ≥18 years ALL in HCR MRD ≥ 0.1% | 116 (65% CR1) | 45 | NR | NR | 80% complete MRD response | 67% | 36.5 months |
| Brown et al, 2021193 | Blinatumomab COG AALL1331 | 1-30 years HR/IR ALL in first relapse | 105 (all salvage 1) | 9 | NR | NR | 79% | 73% | 79% at 24 months |
| Reference . | Study . | Eligibility . | Patients, N . | Median age (y) . | Prior alloHSCT . | ORR . | Molecular response . | Bridge to alloHSCT . | OS estimate or median . |
|---|---|---|---|---|---|---|---|---|---|
| Multicenter antibody-based studies | |||||||||
| Kantarjian et al, 2016122 | INO phase 3 (INO-VATE) | ≥18 years R/R CD22+ ALL | 109 (67% salvage 1) | 47 | 16% | 81% | 63% | 40% | 7.7 mo |
| Topp et al, 2015191 | Blinatumomab phase 2 | ≥18 years Ph-neg R/R ALL CR1 <12 months | 189 (61% salvage 1) | 36 | 34% | 43% | 35% | 40% | 6.1 months |
| Kantarjian et al, 2017192 | Blinatomomab phase 3 (TOWER) | ≥18 years Ph-neg R/R ALL CR1 <12 months | 271 (42% salvage 1) | 37 | 35% | 44% | 36% | 14% | 7.7 months |
| Gokbuget et al, 201867 | Blinatumomab phase 2 (BLAST) | ≥18 years ALL in HCR MRD ≥ 0.1% | 116 (65% CR1) | 45 | NR | NR | 80% complete MRD response | 67% | 36.5 months |
| Brown et al, 2021193 | Blinatumomab COG AALL1331 | 1-30 years HR/IR ALL in first relapse | 105 (all salvage 1) | 9 | NR | NR | 79% | 73% | 79% at 24 months |
| . | . | . | Patients . | . | . | . | . | ||
|---|---|---|---|---|---|---|---|---|---|
| Reference . | Institution . | Coactivation domain . | Screened, N . | Median age, y (range) . | Infused, N . | ORR % . | CRS incidence, % . | Neurotoxicity incidence, % . | OS estimate or median . |
| CART19 studies | |||||||||
| Maude et al, 2014195 | Penn | 4-1BB | NR | 14 (5-60) | 30 | 90% | 100% (severe, 27%) | 43% | 78% at 6 months |
| Davila et al, 2014196 | MSKCC | CD28 | NR | 50 (NA) | 16 | 88% | 44% (severe) | 25% (Gr 3/4) | NR |
| Lee et al, 2015197 | NCI | CD28 | NR | 15 (5-27) | 21 | 67% | 76% (Gr 3/4, 29%) | 19% (Gr 3/4, 5%) | 52% at 12 months |
| Turtle et al, 2016198 | FHCRC | 4-1BB | 32 | 40 (20-73) | 30 | 97% | 83% | 50% (Gr 3/4, 50%) | NR |
| Gardner et al, 2017199 | SCRI | 4-1BB | 45 | 12 (1-25) | 43 | 93% | 93% (severe, 23%) | 44% (severe, 21%) | 69.5% at 12 months |
| Maude et al, 2018200 | Multicentre | 4-1BB | 92 | 11 (3-23) | 75 | 81% | 77% | 40% (Gr 3/4, 13%) | 76% at 12 months |
| Park et al, 2018201 | MSKCC | CD28 | 83 | 44 (23-74) | 53 | 83% | 85% (Gr 3/4, 26%) | 48% (Gr 3/4, 42%) | Median, 12.5 months |
| Hay et al, 2019202 | FHCRC | 4-1BB | 59 | 39 (20-76) | 53 | 85% | NR | NR | Median, 20 months in MRD-neg pts |
| Shah et al, 2021203 | Multicentre | CD28 | 71 | 44 (30–59) | 55 | 71% | 89% (Gr3/4 24%) | 60% (Gr3/4/5 26%) | Median 18.2 months |
| . | . | . | Patients . | . | . | . | . | ||
|---|---|---|---|---|---|---|---|---|---|
| Reference . | Institution . | Coactivation domain . | Screened, N . | Median age, y (range) . | Infused, N . | ORR % . | CRS incidence, % . | Neurotoxicity incidence, % . | OS estimate or median . |
| CART19 studies | |||||||||
| Maude et al, 2014195 | Penn | 4-1BB | NR | 14 (5-60) | 30 | 90% | 100% (severe, 27%) | 43% | 78% at 6 months |
| Davila et al, 2014196 | MSKCC | CD28 | NR | 50 (NA) | 16 | 88% | 44% (severe) | 25% (Gr 3/4) | NR |
| Lee et al, 2015197 | NCI | CD28 | NR | 15 (5-27) | 21 | 67% | 76% (Gr 3/4, 29%) | 19% (Gr 3/4, 5%) | 52% at 12 months |
| Turtle et al, 2016198 | FHCRC | 4-1BB | 32 | 40 (20-73) | 30 | 97% | 83% | 50% (Gr 3/4, 50%) | NR |
| Gardner et al, 2017199 | SCRI | 4-1BB | 45 | 12 (1-25) | 43 | 93% | 93% (severe, 23%) | 44% (severe, 21%) | 69.5% at 12 months |
| Maude et al, 2018200 | Multicentre | 4-1BB | 92 | 11 (3-23) | 75 | 81% | 77% | 40% (Gr 3/4, 13%) | 76% at 12 months |
| Park et al, 2018201 | MSKCC | CD28 | 83 | 44 (23-74) | 53 | 83% | 85% (Gr 3/4, 26%) | 48% (Gr 3/4, 42%) | Median, 12.5 months |
| Hay et al, 2019202 | FHCRC | 4-1BB | 59 | 39 (20-76) | 53 | 85% | NR | NR | Median, 20 months in MRD-neg pts |
| Shah et al, 2021203 | Multicentre | CD28 | 71 | 44 (30–59) | 55 | 71% | 89% (Gr3/4 24%) | 60% (Gr3/4/5 26%) | Median 18.2 months |
FHCRC, Fred Hutchinson Cancer Research Center; HCR, hematologic CR; HR, high risk; IR, intermediate risk; MSKCC, Memorial Sloan Kettering Cancer Center; NCI, National Cancer Institute; NR, not reported; ORR, overall response rate; SCRI, Seattle Children’s Research Institute.