Relatlimab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-RELATLIMAB |
|---|---|
| Тип | Препарат |
| Синоніми | BMS-986016Opdualag (fixed-dose combo with nivolumab)relatlimab-rmbwРелатлімаб |
| Статус | переглянуто 2026-04-27 | очікує клінічного підпису |
| Хвороби | DIS-MELANOMA |
| Джерела | SRC-ESMO-MELANOMA-2024 SRC-NCCN-MELANOMA-2025 |
Дані про препарат
| Клас | Anti-LAG-3 monoclonal antibody (immune checkpoint inhibitor) |
|---|---|
| Механізм дії | Fully human IgG4 monoclonal antibody binding lymphocyte-activation gene 3 (LAG-3, CD223), an inhibitory checkpoint receptor expressed on activated/exhausted T cells, regulatory T cells, and NK cells. By blocking LAG-3 / MHC class II and LAG-3 / FGL1 interactions, relatlimab restores effector T-cell function in the tumor microenvironment, particularly when combined with PD-1 blockade (which targets a non-redundant exhaustion pathway). First-in-class anti-LAG-3 approved for clinical use; available only as a fixed-dose combination with nivolumab (Opdualag). Pivotal evidence RELATIVITY-047 (1L unresectable / metastatic melanoma): nivolumab + relatlimab vs nivolumab monotherapy mPFS 10.2 vs 4.6 mo (HR 0.75); G3+ irAE rate ~21% vs ~12% (clearly lower than nivo+ipi ~55%). |
| Типове дозування | Fixed-dose combination Opdualag: relatlimab 160 mg + nivolumab 480 mg IV over 30 minutes every 4 weeks. Single-vial co-formulation — cannot be dosed independently. Continue until disease progression, unacceptable toxicity, or up to 24 months. No dose adjustment for renal or hepatic impairment (mAb catabolism). Hold for G2-3 irAE (both components held); permanently discontinue for G4 irAE, myocarditis, or recurrent G3 despite re-treatment. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-27 |
Нотатки
Toxicity profile is favorable vs nivo+ipi doublet (G3+ irAE ~21% vs ~55%) with comparable PFS — positions Opdualag as a less-toxic ICI doublet for patients in whom CTLA-4 toxicity is a major concern (older, frail, prior autoimmune history with caution). Hepatitis rate may be modestly higher than nivo monotherapy alone. Baseline workup: TFTs, LFTs, creatinine, cortisol, HbA1c, lipase, troponin if cardiac risk, HBV/HCV serology, dermatologic + pulmonary review, baseline imaging. Monitor TFTs / LFTs / creatinine before each dose for first 6 cycles. Hospitalize and start IV methylprednisolone 1-2 mg/kg/day for G3-4 irAE; consult organ-specialist; escalate to infliximab / mycophenolate / IVIG / ATG for steroid-refractory cases (per ASCO / NCCN / ESMO irAE-management guidelines). Cannot be dose-fractionated — both agents are co-formulated in a single vial.
Де використовується
Regimens
REG-RELATLIMAB-NIVOLUMAB-MELANOMA- Relatlimab + nivolumab (Opdualag, melanoma)