Table 1.
Summary of approved CD19-directed therapies for R/R DLBCL.a
| Regimen | Mechanism of action | Trial | Trial design | Cancer types (n) | Median follow-up, months | ORR, % | CRR, % | Median PFS or EFS, months | Median DOR in patients with response, months | Median OS, months |
|---|---|---|---|---|---|---|---|---|---|---|
| Axicabtagene ciloleucel | Anti-CD19 CAR-T + CD28 CS domain | ZUMA-1 (33) | Phase I/II | DLBCL (77), PMBCL (8), and TFL (16) | 15.4 | 82 | 54 | 5.8 (PFS) | NR | NR |
| ZUMA-1, extended follow-up (110) | Phase I/II, extended follow-up | DLBCL (77), PMBCL (8), and TFL (16) | 63.1 | 83 | 58 | 5.9 (PFS) | 62.2 | 25.8 | ||
| ZUMA-7 (35) | Phase III, axi-cel vs. SOC (chemoimmunotherapy followed by ASCT) as second-line therapy for R/R LBCL | DLBCL (126), HGBCL (31), not confirmed (18), and other (5) | 24.9 | 83 | 65 | 14.7 (PFS) and 8.3 (EFS) | 26.9 | NR | ||
| ZUMA-7, extended follow-up (14) | Phase III, axi-cel vs. SOC (chemotherapy + ASCT) as second-line therapy for R/R LBCL, extended follow-up | DLBCL (126), HGBCL (31), not confirmed (18), and other (5) | 47.2 | 83 | 61 | 14.7 (PFS) and 10.8 (EFS) | 41.7 | NR | ||
| Tisagenlecleucel | Anti-CD19 CAR-T + 4-1BB CS domain | JULIET (29) | Phase II | DLBCL (88), TFL (21), and other (2) | 14 | 52 | 40 | Not reported | NR | 8.3 |
| JULIET, extended follow-up (15) | Phase II, extended follow-up | DLBCL (92), HGBCL (17), and TFL (21) | 40.3 | 53 | 39 | 2.9 (PFS) and 2.8 (EFS) | Not estimable | 11.1 | ||
| BELINDA (36) | Phase III, tisa-cel vs. SOC as second-line therapy for R/R aggressive B-cell lymphoma | DLBCL (101), HGBCL (39), PMBCL (12) FL (5), and other (5) | 10 | 46.30 | 28.40 | 3 (EFS) | Not reported | Not estimable | ||
| Lisocabtagene maraleucel | Anti-CD19 CAR-T + 4-1BB CS domain | TRANSCEND NHL 001 (37) | Phase I/II | DLBCL (215), HGBCL (36), PMBCL (15) and FL (3) | 18.8 | 73 | 53 | 6.8 (PFS) | NR | 21.1 |
| TRANSCEND, extended follow-up (38) | Phase I/II, extended follow-up | DLBCL (276), HGBCL (44), PMBCL (21), and FL (4) | 24 | 73 | 53 | 6.8 (PFS) | 26.1 | 27.3 | ||
| TRANSFORM (39) | Phase III, liso-cel vs. SOC (chemotherapy + ASCT) as second-line therapy for R/R LBCL, extended follow-up | DLBCL (66), HGBCL (22), PMBCL (8), THRBCL (1), and FL (1) | 17.5 | 87 | 74 | NR (EFS and PFS) | NR | 29.9 | ||
| Tafasitamab + lenalidomide | Anti–CD19-induced ADCC and ADCP | L-MIND (23) | Phase II | DLBCL (81) | 13.2 | 60 | 43 | 12.1 (PFS) | 21.7 | NR |
| L-MIND, extended follow-up (13) | Phase II, extended follow-up | DLBCL (81) | 44 | 57.50 | 41.20 | 11.6 (PFS) | NR | 33.5 | ||
| Loncastuximab tesirine | Anti-CD19 ADC | LOTIS-2 (26) | Phase II | DLBCL (127), HGBCL (11), and PMBCL (7) | 7.8 | 48.30 | 24 | 4.9 (PFS) | 10.3 | 9.9 |
| LOTIS-2, extended follow-up (27) | Phase II, extended follow-up | DLBCL (127), HGBCL (11), and PMBCL (7) | 7.8 | 48 | 25 | 4.9 (PFS) | NR | 9.5 |
ADCC, antibody-dependent cell-mediated cytotoxicity; ADCP, antibody-dependent cellular phagocytosis; CS, costimulatory; DOR, duration of response; FL, follicular lymphoma; HGBCL, high-grade B-cell lymphoma; NR, not reached; PMBCL, primary mediastinal large B-cell lymphoma; TFL, transformed follicular lymphoma; THRBCL, T-cell/histiocyte-rich large B-cell lymphoma.
a
This summary is provided for ease of reference to the applicable studies only. The populations and methodology are substantially different in each study, and outcomes should not be directly compared.