Talquetamab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-TALQUETAMAB |
|---|---|
| Тип | Препарат |
| Синоніми | TalveyТалквотамаб |
| Статус | переглянуто 2026-04-29 | очікує клінічного підпису |
| Хвороби | Не вказано |
| Джерела | SRC-ESMO-MM-2023 SRC-NCCN-MM-2025 |
Дані про препарат
| Клас | GPRC5D × CD3 bispecific T-cell engager (humanized IgG4) |
|---|---|
| Механізм дії | Humanized IgG4 bispecific antibody binding GPRC5D (G-protein- coupled receptor family C group 5 member D, highly expressed on malignant plasma cells with restricted normal-tissue expression to keratinized epithelia + hair follicles + tongue) on one arm and CD3 on T-cells. Redirects T-cell cytotoxicity to GPRC5D+ myeloma. First-in-class non-BCMA bispecific — orthogonal target for patients progressing on BCMA-directed therapy. On-target off-tumor toxicity profile reflects normal GPRC5D expression (taste/skin/nail toxicities). |
| Типове дозування | Two approved schedules: weekly 0.4 mg/kg SC (step-up: 0.01 → 0.06 → 0.4 mg/kg SC q3-4d) or biweekly 0.8 mg/kg SC (step-up: 0.01 → 0.06 → 0.3 → 0.8 mg/kg SC). Hospitalization required for step-up doses. Maintenance until progression. Biweekly schedule preferred for prolonged therapy (improved tolerability; reduced infection surveillance burden). |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-29 |
Застереження
- Cytokine release syndrome (CRS) — ~75% any grade, ~2% Grade ≥3 in MonumenTAL-1
- Neurologic toxicity / ICANS (~10%)
- Oral toxicity (dysgeusia, dysphagia, dry mouth) — ~75%, distinctive class effect
- Skin/nail toxicity (rash, palmoplantar exfoliation, nail dystrophy) — ~70%
- Weight loss (>5% in ~40%; secondary to taste/oral toxicity)
Нотатки
MonumenTAL-1 (Chari 2022, NEJM): triple-class refractory MM after ≥4 prior lines — ORR ~73% (weekly cohort), ~74% (biweekly cohort), mDOR ~9-13 mo. FDA accelerated approval Aug 2023; EMA Aug 2023. Distinctive toxicity profile: taste/oral/nail/skin AEs reflect GPRC5D expression in keratinized tissues — manageable but quality- of-life-impacting; nutrition + dental support critical. Lower infection burden vs BCMA bispecifics (different antigen niche; intact humoral immunity). Useful for sequencing post-BCMA failure (orthogonal target). NOTE: Pivotal trial Source SRC-MONUMENTAL-1-CHARI-2022 not yet in KB — evidence base cited via NCCN-MM and ESMO-MM guideline references; flag for source- stub creation.
Де використовується
Regimens
REGIMEN-TALQUETAMAB-MONO-MM- Talquetamab GPRC5D × CD3 bispecific monotherapy — SC (post step-up; QW or Q2W schedule)REGIMEN-TALQUETAMAB-QW-Q2W-MM- Talquetamab GPRC5D × CD3 bispecific — Q2W maintenance schedule (MonumenTAL-1 cohort B)REGIMEN-TALQUETAMAB-STEP-UP-DOSING-MM- Talquetamab GPRC5D × CD3 bispecific — inpatient step-up dosing schedule