Clinical performance of approved TCEs
| TCE . | Target . | Indication . | Efficacy . | Safety . | Ref . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Responses . | mDOR . | mPFS . | mOS . | CRS or ICANS . | TRSAE . | Specific AE . | |||||
| . | . | . | . | All grades . | ≥ grade 3 . | . | . | ||||
| Blinatumomab | CD19 | r/r B-ALL, phase 3 | CR 34% vs. 16% SOC | | 7.3 vs. 4.6 m SOC | 7.7 vs. 4 m SOC | 14.2% CRS | 4.9% CRS, 9.4% neurologic events | 3% fatal, 4% CRS | CRS, neurologic events, infusion reactions, sepsis, infections, cytopenias | Kantarjian et al. (2017), Pulte et al. (2018) |
| r/r B-ALL, real-world data | Ph−, 46% CR, Ph+, 41% CR | | Ph−, 11 m, Ph+, 6.7 m | Ph−, 12.2 m, Ph+, 16.3 m | | | | | Boissel et al. (2023) | ||
| Mosunetuzumab | CD20 | r/r FL | 80% ORR, 60% CR | 22.8 m | 17.9 m | 89.6% (18 m) | 43% CRS, 5% mild ICANS | 2% CRS | 47% | CRS, neurologic events, infections, cytopenias | Budde et al. (2022b) |
| Epcoritamab | CD20 | r/r LBCL, 2-year follow-up | 63.1% ORR, 40.1% CR | 17.3 m | 4.4 m | 18.5 m | 51% CRS, 6.4% ICANS | 3.2% CRS, 0.6% ICANS | 11.5%. 0.6% fatal ICANS, 0.6% COVID-19 pneumonia, 0.6% bacterial pneumonia | CRS, neurologic events, neutropenia, infections | Thieblemont et al. (2023, 2024) |
| r/r FL | r/r FL, optimization cohort: 91% ORR, 68% CR | | | | r/r FL, optimization cohort: 49% CRS, 0% ICANS | r/r FL, optimization cohort: 0% CRS, 0% ICANS | | | Linton et al. (2024), Vose et al. (2024) | ||
| Glofitamab | CD20 | r/r B-NHL | 53.8% ORR, 36.8% CR (at RP2D: 65.7 and 57.1%) | 5.5 m | 2.9 m | | 50.3% CRS, 5.2% ICANS, 43.3% neurologic AE | 3.5% CRS, 1.2% ICANS | 45%, none fatal | CRS, neurologic, infections, neutropenia | (Hutchings et al., 2021) |
| r/r MCL | 85% ORR, 78.3% CR | 16.2 m | 16.8 m | 29.9 m | 70% CRS, 11.7% neurologic AE | 11.6% CRS, no neurologic AE | 60%, none grade 5 (fatal) | | (Phillips et al., 2025) | ||
| Odronextamab | CD20 | r/r FL | 80% ORR, 73% CR | 22.6 m | 20.7 m | NR | 56% CRS, 0.8% ICANS | 0.8% CRS, no ICANS | 44.5%, 3% fatal | CRS, cytopenias, infections, pyrexia | Blair (2024), Kim et al. (2024) |
| r/r DLBCL | 52% ORR, 31% CR | 10.2 m | | | 55% CRS, no ICANS | 1% CRS, no ICANS | 4% fatal COVID-19 infections | CRS, cytopenias, infections, pyrexia | Ayyappan et al. (2023), Blair (2024) | ||
| Teclistamab | BCMA | r/r MM, 2-year follow-up | Original ORR 63%, 58.8% VGPR or better; 2-year follow-up: 43% CR | 24 m | 12.5 m | 21.9 m | 72% CRS, 14.5% neurologic events, 3% ICANS | 0.6% CRS, 0.6% neurologic events, 0% ICANS | 3.6% deaths | CRS, neurologic events, infections, cytopenias, hypogammaglobulinemia | Donk et al. (2023), Moreau et al. (2022) |
| Elranatamab | BCMA | r/r MM | Original, 56% VGPR or better, 35% CR; Prolonged follow-up: 61% ORR, 37.4% CR | NR | 17.2 m | 24.6 m | 57.7% CRS, 4.9% ICANS | 0% CRS, 0% ICANS | 3.25% deaths (2.4% lethal infections) | CRS, cytopenias, neutropenia, infections | Lesokhin et al. (2023), Tomasson et al. (2024) |
| Linvoseltamab-gcpt | BCMA | r/r MM | 70% ORR, 45% CR or better, 19% VGPR | NR. Bumma: 29.4 m | Bumma: NR | Bumma: 31.4 m | 46% CRS, 8% ICANS | 0.9% CRS, 2.6% ICANS | 74% SAE, 7% fatal: 3.4% sepsis, 0.9% chronic kidney disease, 0.9% pneumonia, 0.9% TLS, 0.9% encephalopathy | CRS, neurologic events, infusion reactions, infections, cytopenias | Bumma et al. (2024), Regeneron Pharmaceuticals (2025a) |
| Talquetamab | GPRC5D | r/r MM | 73–74% ORR, 57–59% VGPR or better; Phase 1: 64–70% ORR, 52–57% VGPR or better, 23% CR | | 7.5–11.9 m | | 75–79% CRS, 11% ICANS | Phase 1: 0–3% CRS | No deaths | CRS, neurologic, infections, skin-related, nail-related, dysgeusia, cytopenias, hypogammaglobulinemia | Chari et al. (2022), Schinke et al. (2023) |
| Tebentafusp | gp100/HLA-A*02:01 | Uveal melanoma, phase 3, 3-year follow-up | ORR 11% vs. 5% IC; CR <1% vs. 0% | 11.1 vs. 9.7 m | 3.4 vs. 2.9 m | 21.6 vs. 16.9 m | 89% CRS | 1% CRS | | CRS, skin events | Hassel et al. (2023), Nathan et al. (2021) |
| Tarlatamab | DLL3 | Pretreated ES-SCLC | 10 mg: 40% ORR, 1% CR. 100 mg: 32% ORR, 8% CR | | 10 mg: 4.9 m. 100 mg: 3.9 m | 10 mg: 14.3 m. 100 mg: NE | 10 mg: 51% CRS, 8% ICANS. 100 mg: 61% CRS, 28% ICANS | 10 mg: 1% CRS, 0% ICANS. 100 mg: 6% CRS, 5% ICANS | 10 mg: 1% fatal respiratory failure | CRS, neurologic events, cytopenias | Ahn et al. (2023), Herrera et al. (2024) |
| Catumaxomab | EpCAM | Malignant ascites in adults with EpCAM+ carcinomas | | | mPuFS, OC: 48 vs. 11 d (control)*. mPuFS, non-OC: 30 vs. 14 d (control)* | 72 vs. 71 d (control)* | 23% CRS | 11/41 CRS episodes | 15%. Integrated analysis of 11 studies: SIRS, hepatic failure | CRS, SIRS, abdominal pain, cytopenias, elevated liver enzymes, infections | EMA (2025), Syed (2025) |
| TCE . | Target . | Indication . | Efficacy . | Safety . | Ref . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Responses . | mDOR . | mPFS . | mOS . | CRS or ICANS . | TRSAE . | Specific AE . | |||||
| . | . | . | . | All grades . | ≥ grade 3 . | . | . | ||||
| Blinatumomab | CD19 | r/r B-ALL, phase 3 | CR 34% vs. 16% SOC | | 7.3 vs. 4.6 m SOC | 7.7 vs. 4 m SOC | 14.2% CRS | 4.9% CRS, 9.4% neurologic events | 3% fatal, 4% CRS | CRS, neurologic events, infusion reactions, sepsis, infections, cytopenias | Kantarjian et al. (2017), Pulte et al. (2018) |
| r/r B-ALL, real-world data | Ph−, 46% CR, Ph+, 41% CR | | Ph−, 11 m, Ph+, 6.7 m | Ph−, 12.2 m, Ph+, 16.3 m | | | | | Boissel et al. (2023) | ||
| Mosunetuzumab | CD20 | r/r FL | 80% ORR, 60% CR | 22.8 m | 17.9 m | 89.6% (18 m) | 43% CRS, 5% mild ICANS | 2% CRS | 47% | CRS, neurologic events, infections, cytopenias | Budde et al. (2022b) |
| Epcoritamab | CD20 | r/r LBCL, 2-year follow-up | 63.1% ORR, 40.1% CR | 17.3 m | 4.4 m | 18.5 m | 51% CRS, 6.4% ICANS | 3.2% CRS, 0.6% ICANS | 11.5%. 0.6% fatal ICANS, 0.6% COVID-19 pneumonia, 0.6% bacterial pneumonia | CRS, neurologic events, neutropenia, infections | Thieblemont et al. (2023, 2024) |
| r/r FL | r/r FL, optimization cohort: 91% ORR, 68% CR | | | | r/r FL, optimization cohort: 49% CRS, 0% ICANS | r/r FL, optimization cohort: 0% CRS, 0% ICANS | | | Linton et al. (2024), Vose et al. (2024) | ||
| Glofitamab | CD20 | r/r B-NHL | 53.8% ORR, 36.8% CR (at RP2D: 65.7 and 57.1%) | 5.5 m | 2.9 m | | 50.3% CRS, 5.2% ICANS, 43.3% neurologic AE | 3.5% CRS, 1.2% ICANS | 45%, none fatal | CRS, neurologic, infections, neutropenia | (Hutchings et al., 2021) |
| r/r MCL | 85% ORR, 78.3% CR | 16.2 m | 16.8 m | 29.9 m | 70% CRS, 11.7% neurologic AE | 11.6% CRS, no neurologic AE | 60%, none grade 5 (fatal) | | (Phillips et al., 2025) | ||
| Odronextamab | CD20 | r/r FL | 80% ORR, 73% CR | 22.6 m | 20.7 m | NR | 56% CRS, 0.8% ICANS | 0.8% CRS, no ICANS | 44.5%, 3% fatal | CRS, cytopenias, infections, pyrexia | Blair (2024), Kim et al. (2024) |
| r/r DLBCL | 52% ORR, 31% CR | 10.2 m | | | 55% CRS, no ICANS | 1% CRS, no ICANS | 4% fatal COVID-19 infections | CRS, cytopenias, infections, pyrexia | Ayyappan et al. (2023), Blair (2024) | ||
| Teclistamab | BCMA | r/r MM, 2-year follow-up | Original ORR 63%, 58.8% VGPR or better; 2-year follow-up: 43% CR | 24 m | 12.5 m | 21.9 m | 72% CRS, 14.5% neurologic events, 3% ICANS | 0.6% CRS, 0.6% neurologic events, 0% ICANS | 3.6% deaths | CRS, neurologic events, infections, cytopenias, hypogammaglobulinemia | Donk et al. (2023), Moreau et al. (2022) |
| Elranatamab | BCMA | r/r MM | Original, 56% VGPR or better, 35% CR; Prolonged follow-up: 61% ORR, 37.4% CR | NR | 17.2 m | 24.6 m | 57.7% CRS, 4.9% ICANS | 0% CRS, 0% ICANS | 3.25% deaths (2.4% lethal infections) | CRS, cytopenias, neutropenia, infections | Lesokhin et al. (2023), Tomasson et al. (2024) |
| Linvoseltamab-gcpt | BCMA | r/r MM | 70% ORR, 45% CR or better, 19% VGPR | NR. Bumma: 29.4 m | Bumma: NR | Bumma: 31.4 m | 46% CRS, 8% ICANS | 0.9% CRS, 2.6% ICANS | 74% SAE, 7% fatal: 3.4% sepsis, 0.9% chronic kidney disease, 0.9% pneumonia, 0.9% TLS, 0.9% encephalopathy | CRS, neurologic events, infusion reactions, infections, cytopenias | Bumma et al. (2024), Regeneron Pharmaceuticals (2025a) |
| Talquetamab | GPRC5D | r/r MM | 73–74% ORR, 57–59% VGPR or better; Phase 1: 64–70% ORR, 52–57% VGPR or better, 23% CR | | 7.5–11.9 m | | 75–79% CRS, 11% ICANS | Phase 1: 0–3% CRS | No deaths | CRS, neurologic, infections, skin-related, nail-related, dysgeusia, cytopenias, hypogammaglobulinemia | Chari et al. (2022), Schinke et al. (2023) |
| Tebentafusp | gp100/HLA-A*02:01 | Uveal melanoma, phase 3, 3-year follow-up | ORR 11% vs. 5% IC; CR <1% vs. 0% | 11.1 vs. 9.7 m | 3.4 vs. 2.9 m | 21.6 vs. 16.9 m | 89% CRS | 1% CRS | | CRS, skin events | Hassel et al. (2023), Nathan et al. (2021) |
| Tarlatamab | DLL3 | Pretreated ES-SCLC | 10 mg: 40% ORR, 1% CR. 100 mg: 32% ORR, 8% CR | | 10 mg: 4.9 m. 100 mg: 3.9 m | 10 mg: 14.3 m. 100 mg: NE | 10 mg: 51% CRS, 8% ICANS. 100 mg: 61% CRS, 28% ICANS | 10 mg: 1% CRS, 0% ICANS. 100 mg: 6% CRS, 5% ICANS | 10 mg: 1% fatal respiratory failure | CRS, neurologic events, cytopenias | Ahn et al. (2023), Herrera et al. (2024) |
| Catumaxomab | EpCAM | Malignant ascites in adults with EpCAM+ carcinomas | | | mPuFS, OC: 48 vs. 11 d (control)*. mPuFS, non-OC: 30 vs. 14 d (control)* | 72 vs. 71 d (control)* | 23% CRS | 11/41 CRS episodes | 15%. Integrated analysis of 11 studies: SIRS, hepatic failure | CRS, SIRS, abdominal pain, cytopenias, elevated liver enzymes, infections | EMA (2025), Syed (2025) |
Data are from published pivotal trials, including recent updates and select real-world data. Additional discussions are in references Falchi et al. (2023), Herrera et al. (2024), and Strohl (2024). Specific AE are AE considered specific for the respective TCE. * indicates that the trial compared catumaxomab + paracentesis treatment with paracentesis-only controls. However, the control group included crossover patients and thus may overestimate efficacy in that group. AE, adverse effects; BCMA, B cell maturation antigen, also known as tumor necrosis factor receptor superfamily member 17 (TNFRSF17); d, day(s); gp100, glycoprotein 100, also known as premelanosome protein (PMEL); GPRC5D, G protein–coupled receptor family C group 5 member D; HLA, human leukocyte antigen; IC, investigator’s choice therapy; m, months; MCL, mantle cell lymphoma; mDOR, median duration of response; mPuFS, median puncture-free survival; mPFS, median progression-free survival; NE, not evaluated; NR, not reached; OC, ovarian cancer; ORR, objective response rate; OS, overall survival (duration in parentheses); Ph, Philadelphia chromosome; r/r, relapsed or refractory; RP2D, recommended phase 2 dose; SIRS, systemic inflammatory response syndrome; SOC, standard of care; TLS, tumor lysis syndrome; VGPR, very good partial response.