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Glofitamab IV monotherapy with obinutuzumab pretreatment, fixed-duration 12 cycles, for r/r DLBCL ≥3L (NP30179)

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Source YAML: dossier complet

ComposantesAucune déclaration
IDREGIMEN-GLOFITAMAB-MONO-DLBCL-3L
TypeProtocole thérapeutique
Étatreviewed 2026-05-01 | pending_clinical_signoff
MaladiesAucune déclaration
SourcesSRC-ESMO-DLBCL-2024 SRC-NCCN-BCELL-2025

Notes

IV CD20×CD3 bispecific T-cell engager (2:1 CD20-bivalent / CD3-monovalent format) with fixed 12-cycle duration for relapsed/refractory diffuse large B-cell lymphoma after ≥2 prior lines. NP30179 pivotal phase 2 (Dickinson et al., NEJM 2022): in r/r DLBCL ≥3L (n=155, ~33% prior CAR-T) — ORR ~52%, CR ~39%, median CR DOR not reached, 12-month PFS among CR responders ~71%, OS at 12 months ~50%. Obinutuzumab 1000 mg IV pretreatment day -7 + step-up dosing (2.5 → 10 → 30 mg in cycle 1) + corticosteroid premedication suppress CRS to predominantly Grade 1-2 (any-grade ~63%, G≥3 ~4%). ICANS ~8% any-grade. Distinguishing feature vs epcoritamab is fixed 12-cycle duration (~8.5 months from cycle 1 day 1) vs continuous indefinite dosing — improves treatment-free interval + immune reconstitution but raises re-treatment-on-progression question (not established). See REGIMEN-GLOFITAMAB-OBINUTUZUMAB-PRETREATMENT for the standalone day -7 sub-regimen. Bibliographic record SRC-NP30179-DICKINSON-2022 is available; clinical claim linkage requires dual clinical sign-off.

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