Epcoritamab
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-EPCORITAMAB |
|---|---|
| Type | Drug |
| Aliases | EpkinlyTepkinlyЕпкоритамаб |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-DLBCL-2024 SRC-ESMO-FL-2024 SRC-NCCN-BCELL-2025 |
Drug Facts
| Class | CD20 × CD3 bispecific T-cell engager (humanized IgG1, DuoBody platform; SC administration) |
|---|---|
| Mechanism | Humanized IgG1 bispecific antibody (Genmab DuoBody platform) binding CD20 on B-cells and CD3 on T-cells, redirecting polyclonal T-cell cytotoxicity to CD20+ malignant B-cells. Subcutaneous administration with step-up dosing schedule mitigates first-cycle CRS. First-in-class SC CD20×CD3 bispecific (vs IV mosunetuzumab/glofitamab) — improves ambulatory administration profile. |
| Typical dosing | Step-up dosing required (CRS mitigation): 0.16 mg SC day 1 (cycle 1), 0.8 mg SC day 8 (cycle 1), 48 mg SC day 15 (cycle 1) and day 22. Cycles 2-3 (28-day cycles): 48 mg SC weekly. Cycles 4-9: 48 mg SC every 2 weeks. Cycles 10+: 48 mg SC every 4 weeks until progression / unacceptable toxicity. Hospitalization required for first 48 mg dose (cycle 1 day 15, 24h observation). |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-29 |
Warnings
- Cytokine release syndrome (CRS) — ~50% any grade, ~3% Grade ≥3 in EPCORE NHL-1
- Neurologic toxicity / ICANS (~6%)
- Serious infections — Grade ≥3 ~15-20%
Notes
EPCORE NHL-1 (Thieblemont 2023, JCO): r/r DLBCL after ≥2 prior lines (median 3; ~38% post-CAR-T) — ORR 63%, CR 39%, mDOR ~12 mo. Subset r/r FL ≥2L (Linton 2023, Lancet Haematol): ORR 82%, CR 63%. FDA accelerated approval May 2023 (DLBCL), Jun 2024 (FL). Distinct from CAR-T: off-the-shelf, no lymphodepletion, ambulatory after cycle 1 day 15. Useful in patients ineligible for CAR-T (frailty, comorbidity, manufacturing delay) or post-CAR-T progression. Lower depth/duration of response vs CAR-T in DLBCL but better tolerability. Hospital observation required for first 48 mg dose (cycle 1 day 15). Mandatory PJP + HSV prophylaxis; IVIG for IgG <400. NOTE: Pivotal trial Source SRC-EPCORE-NHL-1-THIEBLEMONT-2023 not yet in KB — evidence base cited via NCCN-BCELL and ESMO-DLBCL/FL guideline references; flag for source-stub creation.
Used By
Regimens
REGIMEN-EPCORITAMAB-MONO-DLBCL-3L- Epcoritamab SC monotherapy for r/r DLBCL ≥3L (EPCORE NHL-1)REGIMEN-EPCORITAMAB-STEP-UP-DOSING- Epcoritamab cycle-1 step-up dosing sub-regimen (CRS mitigation)