Tarlatamab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-TARLATAMAB |
|---|---|
| Тип | Препарат |
| Синоніми | ImdelltraТарлатамаб |
| Статус | переглянуто 2026-05-08 | очікує клінічного підпису |
| Хвороби | DIS-SCLC |
| Джерела | SRC-DELLPHI-301-AHN-2023 SRC-ESMO-SCLC-2021 SRC-NCCN-SCLC-2025 |
Дані про препарат
| Клас | DLL3 × CD3 bispecific T-cell engager (BiTE) |
|---|---|
| Механізм дії | Bispecific antibody construct (half-life-extended BiTE format, IgG-like scaffold) binding delta-like ligand 3 (DLL3) on small-cell-lung-cancer tumor cells AND CD3ε on T cells, forming a tumor-redirected immunological synapse that activates polyclonal cytotoxic T-cell killing of DLL3-expressing tumor cells. DLL3 is an inhibitory Notch ligand aberrantly expressed on the surface of ~85-95% of SCLC tumors but minimally on normal tissues, making it a tumor-selective target. Distinct from blinatumomab (anti-CD19 × CD3 BiTE for B-ALL) in: (1) solid-tumor target (DLL3 on SCLC) vs hematologic; (2) longer half-life (~Fc-extended) permitting q2w IV bolus dosing rather than continuous infusion; (3) requires step-up dosing (1 mg cycle 1 day 1) with inpatient monitoring to mitigate cytokine release syndrome (CRS). Does not require pre-treatment DLL3 testing for label use — most SCLCs are DLL3-positiv... |
| Типове дозування | Step-up regimen (mandatory) followed by maintenance: Cycle 1 day 1: 1 mg IV (priming dose) — inpatient monitoring ≥22 hours Cycle 1 day 8: 10 mg IV — inpatient monitoring ≥22 hours Cycle 1 day 15: 10 mg IV (outpatient acceptable if D1 + D8 well-tolerated) Cycles 2+: 10 mg IV every 2 weeks Continuous q2w until disease progression or unacceptable toxicity. Premedication: dexamethasone 8 mg IV + antihistamine (e.g. diphenhydramine 25-50 mg IV) + acetaminophen 650-1000 mg PO ≥30-60 min before each of the first 2 doses (cycle 1 D1 + D8); IV hydration (1 L NS) before and after first 2 doses. Hospitalization for 22+ hours post-infusion mandatory for cycle 1 D1 and D8 to monitor for CRS. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-05-08 |
Застереження
- Cytokine release syndrome (CRS) — fatal cases reported; Grade ≥3 ~1%, any-grade ~50% in DeLLphi-301; mandatory step-up dosing + inpatient monitoring cycle 1 D1 and D8 required
- Neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS) — Grade ≥3 ~7%; monitor for confusion, tremor, aphasia, seizures
Нотатки
First-in-class DLL3 × CD3 bispecific T-cell engager (Amgen). FDA accelerated approval May 2024 for extensive-stage SCLC with disease progression on or after platinum-based chemotherapy, on the basis of DeLLphi-301 (Ahn et al., NEJM 2023; n=222 across 10 mg q2w and 100 mg q2w cohorts; 10 mg q2w cohort n=99 — confirmed ORR 40% per independent central review, mDoR not reached at 10.6 mo follow-up, mPFS 4.9 mo, mOS 14.3 mo). 10 mg q2w selected as the registered dose (favorable safety/efficacy ratio; similar ORR with lower CRS rate than 100 mg). ESCAT tier IIA (FDA-approved disease-specific 2L+ ES-SCLC). Distinct from blinatumomab BiTE in solid-tumor target (DLL3) and dosing format (q2w bolus vs continuous infusion). Mandatory step-up cycle 1 + inpatient monitoring 22+ hours post-infusion D1 and D8 to detect early CRS. CRS mostly Grade 1-2 (fever, hypotension, hypoxia) and managed with supportive care + tocilizumab when needed; severe CRS (Grade ≥3) ~1%. Neurologic toxicity (ICANS-like) Grade ≥3 ~7% — generally reversible with corticosteroids. EMA review pending. Confirmatory phase 3 DeLLphi-304 (tarlatamab vs investigator-choice chemotherapy in 2L ES-SCLC) ongoing. Also under investig...
Де використовується
Regimens
REG-TARLATAMAB- Tarlatamab — 2L+ extensive-stage SCLC (DeLLphi-301; DLL3 × CD3 BiTE)