Table 2.
Summary of BiTE clinical trials presented.
| Study agent | Median number of previous lines | Dosing | CRS | Responses |
|---|---|---|---|---|
| AMG 420 (n=42) | 5 Dara refractory: 21% BCMA-T: NA |
IV | 38% Grade 2: n=2 Grade 3: n=1 |
ORR (at MTD): 70% CR: n=5 VGPR: n=1 PR: n=1 |
| AMG 701 (n=75) | 6 Triple-refractory: 68% BCMA-T: NA |
IV | 61% Grade 1: 25% (n=19) Grade 2: 28% (n=21) Grade 3: 7% (n=5) |
ORR (3–12mg): 36% sCR: n=4 CR: n=1 VGPR: n=6 PR: n=6 |
| PF-06863135 (n=35) | 11 (IV) 7 (SC) BCMA-T: Allowed (n=9) |
IV/SC | 24% (IV) All grade 1–2 61% (SC) All grade 1–2 |
IV cohort MR: n=1 SD: n=6 DP: n=9 SC cohort sCR: n=2 VGPR: n=2 PR: n=2 SD: n=7 |
| REGN5458 (n=45) | 5 Triple-refractory: 6.7% Quad-refractory: 33.3% Penta-refractory: 53.3% BCMA-T: NA |
IV | 37.8% Grade 1: 88.2% No Gr >3 |
ORR: 35.6% ORR (EMP): 16.7% ≥ sCR/CR: 31.3% ≥ VGPR: 81.3% |
| Teclistamab (n=128) | 6 Triple-refractory: 79% Penta-refractory: 38% BCMA-T: NA |
IV/SC | 55% (IV) All grade 1–2 50% (SC) All grade 1–2 |
ORR: 63.8% ≥ CR: 9 ≥ VGPR: 24 |
| TNB-383B (n=38) | 7 BCMA-T: NA |
IV | 21% (n=8) Grade 1: 13% (n=5) Grade 2: 8% (n=3) |
ORR: 37% sCR/CR: 7.9% VGPR: 11% PR: 18% mDOR: 9 weeks |
| Cevostamab (n=51) | 6 Triple-refractory: 66.7% BCMA-T: Allowed (n=3) |
IV | 74.5% Grade 1: 39.2% (n=20) Grade 2: 33.3% (n=17) Grade 3: 2.0% (n=1) |
At ≥ 3.6/20 mg dose level ORR: 51.7% sCR: 10.3% CR: 10.3% VGPR: 13.8% |
| Talquetamab (n=137) | 6 Triple-refractory: 79% Penta-refractory: 31% BCMA-T: Allowed (n=21) |
IV/SC | 47% Mostly grade 1–2 Grade 3 (only IV): n=5 |
Most active IV/SC doses ORR: 66% ORR (IV): 78% ORR (SC): 67% |
BCMA-T, BCMA-targeted therapy; BiTE, bispecific T cell engager; CR, complete response; CRS, cytokine release syndrome; DP, disease progression; EMP, extramedullary plasmacytoma; IV, intravenous; mDOR, median duration of response; MTD, maximum tolerated dose; NA, not-allowed; ORR, overall response rate; PR, partial response; SC, subcutaneous; sCR, stringent CRs; SD, stable disease; VGPR, very good partial response.