Zolbetuximab
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-ZOLBETUXIMAB |
|---|---|
| Type | Drug |
| Aliases | VyloyЗольбетуксимаб |
| Status | reviewed 2026-04-30 | pending_clinical_signoff |
| Diseases | DIS-GASTRIC |
| Sources | SRC-ESMO-GASTRIC-2024 SRC-NCCN-GASTRIC-2025 |
Drug Facts
| Class | Anti-CLDN18.2 chimeric IgG1 monoclonal antibody |
|---|---|
| Mechanism | Chimeric IgG1 monoclonal antibody targeting Claudin-18 isoform 2 (CLDN18.2), a tight-junction protein normally restricted to gastric mucosa but aberrantly retained in gastric/GEJ adenocarcinoma cells. Mechanisms: ADCC (NK cell-mediated via FcγRIIIa) and CDC (complement- dependent cytotoxicity). Combined with chemotherapy backbone (mFOLFOX6 in SPOTLIGHT, CAPOX in GLOW) for 1L HER2-negative CLDN18.2-positive (≥75% of tumor cells with 2+/3+ membranous staining) metastatic gastric / GEJ adenocarcinoma. |
| Typical dosing | Loading dose 800 mg/m² IV cycle 1 day 1; maintenance 600 mg/m² IV q3w (with CAPOX) or q2w (with mFOLFOX6). Slow infusion: cycle 1 over ≥4 hours, subsequent cycles ≥2 hours. Pre-medication for nausea mandatory. Companion diagnostic VENTANA CLDN18 (43-14A) RxDx required before initiation. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-30 |
Notes
First-in-class anti-CLDN18.2 mAb. SPOTLIGHT (Shitara Lancet 2023): zolbetuximab + mFOLFOX6 vs mFOLFOX6 — mPFS 10.6 vs 8.7 mo (HR 0.75); mOS 18.2 vs 15.5 mo. GLOW (Shah Nat Med 2023): zolbetuximab + CAPOX vs CAPOX — mPFS 8.2 vs 6.8 mo (HR 0.69); mOS 14.4 vs 12.2 mo (HR 0.77). FDA approval Oct 2024. Cycle-1 nausea is the dominant tolerability problem — mitigated by slow infusion + triple-antiemetic prophylaxis (5-HT3 + NK1-RA + dex) + dose interruption / reduction protocol; tolerance generally improves cycles 2+. SRC-SPOTLIGHT and SRC-GLOW source stubs not yet in KB — flagged for source ingestion.
Used By
Regimens
REG-ZOLBETUXIMAB-CHEMO- Zolbetuximab + mFOLFOX6 (SPOTLIGHT) — 1L CLDN18.2-positive HER2-negative gastric/GEJ