Table 7.
Examples of clinical data with T-cell redirecting biologics.
| Property | T-Cell Redirecting Biologic Drug | |||||||
|---|---|---|---|---|---|---|---|---|
| Kymriah® | Blincyto® | Kymriah® | Yescarta® | Liso-cel | Blincyto® | bb2121 | AMG420 | |
| Sponsor | Novartis | Amgen | Novartis | Gilead (Kite) | Juno/Celgene | Amgen | Bluebird/Celgene | Amgen |
| Format | CAR-T; 4-1BB CS | TRBA (BiTE®) | CAR-T; 4-1BB CS | CAR-T; CD28 CS | CAR-T; 4-1BB CS | TRBA (BiTE®) | CAR-T; 4-1BB CS | TRBA (BiTE®) |
| Trial | EL | TW | JU | ZU | TC | Phase 1 | Phase 1 | Phase 1 |
| Target | CD19 | CD19 | CD19 | CD19 | CD19 | CD19 | BCMA | BCMA |
| Indication | B-ALL | B-ALL (PCN) | DLBCL | DLBCL | DLBCL | DLBCL | MM | MM |
| # Number of Patients | 63 | 271 | 93 | 101 | 73 | 11 | 33 | 42 |
| ORR | ND | ND | 52% | 83% | 80% | 55% | 85% | 31% |
| CR/CR * | 83% | 34% | 40% | 58% | 59% | 36% | 45% | 17% |
| PR | 20% | ND | 12% | 25% | 21% | 18% | 39% | 10% |
| Median response duration time | NR | 7.7 mo | 11.7 mo | 11.1 mo | 10.2 mo NR | 13.3 mo | 11.8 mo | NR |
| Grade 3+ AEs | ND | ND | 89% | 98% | 16% | 90% | ND | ND |
| CRS incidence | 77% | 15% | 58% | 58% | 37% | ND | 76% | 38% |
| Grade 3+ CRS | ND | nk | 22% | 11% | 1% | ND | 6% | ND |
| Neurotoxicity | ND | 65% | 21% | 64% | 25% | 71% | ND | ND |
| Grade 3+ Neurotoxicity | ND | 13% | 12% | 32% | 15% | 20% | ND | 0% |
| Elimination half-life | 21.7 d RP; 2.7 d NRP | NA | 91.3 d RP; 15.4 d NRP | ND | ND | NA | ND | NA |
| References | [290] | [384,405] | [290,406] | [291,407] | [408] | [393,409] | [295,410] | [411,412] |
* Abbreviations: B-ALL, B-cell acute lymphoblastic leukemia; BCMA, B-cell maturation antigen; CD, cluster of differentiation; BiTE®, bispecific T-cell engager (short half-life, continuously infused); d, days; CAR-T, chimeric antigen receptor T-cell; CS, co-stimulation domain; DLBCL, diffuse large B-cell lymphoma; EL, ELIANA trial; JU, JULIET trial; Liso-cel, Lisocabtagene maraleucel (JCAR017); MM, multiple myeloma; mo, months; NA, not applicable; ND, no data; NR, not reached (during testing period covered); NRP, non-responding patients; PCN, Philadelphia chromosome-negative; RP, responding patients; TC, TRANSCEND-CORE; TRBA, T-cell redirecting bispecific antibody; TW, Tower trial; ZU, ZUMA-1 trial. #: Number.