Dostarlimab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-DOSTARLIMAB |
|---|---|
| Тип | Препарат |
| Синоніми | JemperliTSR-042dostarlimab-gxlyДостарлімаб |
| Статус | переглянуто 2026-04-27 | очікує клінічного підпису |
| Хвороби | DIS-ENDOMETRIAL |
| Джерела | SRC-ESGO-ENDOMETRIAL-2025 SRC-NCCN-UTERINE-2025 |
Дані про препарат
| Клас | Anti-PD-1 humanized IgG4 monoclonal antibody (immune checkpoint inhibitor) |
|---|---|
| Механізм дії | Humanized IgG4κ (S228P-stabilized) monoclonal antibody binding programmed cell death protein 1 (PD-1) on activated T cells, preventing engagement with PD-L1 / PD-L2 and restoring anti-tumor T-cell function. Pharmacologic class is identical to pembrolizumab / nivolumab / cemiplimab; distinct binding epitope with no clinically meaningful efficacy differential. Approved on the basis of GARNET (single-arm endometrial cancer dMMR/MSI-H 2L+: ORR ~45%) and RUBY (1L primary advanced or recurrent endometrial cancer with carbo+pac chemo backbone: dMMR/MSI-H PFS HR 0.30, all-comers PFS HR 0.64, OS benefit), and tumor- agnostic dMMR/MSI-H solid tumors post-platinum. The Cercek 2022 proof-of-concept study in dMMR locally advanced rectal cancer showed clinical CR in 100% of 12 patients (now extended in larger cohorts) — neoadjuvant ICI monotherapy avoiding chemo + RT + surgery in this niche. |
| Типове дозування | Induction: 500 mg IV every 3 weeks for 4 doses (cycles 1-4), followed by maintenance 1000 mg IV every 6 weeks until disease progression / unacceptable toxicity / up to 24 months. In RUBY combo: dostarlimab 500 mg + carboplatin AUC 5 + paclitaxel 175 mg/m² every 3 weeks for 6 cycles, then dostarlimab 1000 mg q6w monotherapy maintenance. Infuse over 30 minutes (first dose); 30 minutes for subsequent doses if first tolerated. No premedication required. No formal renal or hepatic adjustment (mAb catabolism). Hold for G2-3 irAE; permanently discontinue for G4 irAE, myocarditis, recurrent G3 despite steroids, or any life-threatening reaction. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-27 |
Нотатки
RUBY (NEJM 2023) — paradigm-shifting trial in primary advanced / recurrent endometrial cancer: dostarlimab + carbo+pac chemo vs chemo alone, dMMR PFS HR 0.30 (massive effect, OS benefit emerging); all-comers PFS HR 0.64. Has redefined 1L systemic therapy for advanced endometrial cancer along with KEYNOTE-868 (pembrolizumab + chemo). Tumor-agnostic dMMR solid-tumor approval parallels pembrolizumab. Cercek 2022 dMMR rectal study (100% cCR with dostarlimab neoadjuvant — avoiding chemo+RT+surgery) is practice-changing for this rare niche. Baseline workup: TFTs, LFTs, creatinine, cortisol, HbA1c, troponin if cardiac history, HBV/HCV serology, baseline imaging, dermatologic + pulmonary review, dMMR/MSI-H confirmation by IHC or NGS for monotherapy indications. Monitor TFTs / LFTs / creatinine before each dose for first 6 cycles then q2 cycles. Refer for organ-specific consultation at first sign of irAE. UA access via EAP GSK / cross- border / self-pay; not on НСЗУ. Pembrolizumab is the dominant anti-PD-1 used in UA for dMMR endometrial.
Де використовується
Regimens
REG-DOSTARLIMAB-CARBO-PACLI-ENDOM- Dostarlimab + carbo + paclitaxel (endometrial advanced 1L dMMR)REG-DOSTARLIMAB-MONO-ENDOM- Dostarlimab monotherapy (GARNET) — 2L+ dMMR endometrial