Zenocutuzumab
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-ZENOCUTUZUMAB |
|---|---|
| Type | Drug |
| Aliases | BizengriЗенокутузумаб |
| Status | pending_clinical_signoff |
| Diseases | DIS-NSCLC |
| Sources | SRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-NSCLC-2025 |
Drug Facts
| Class | HER2 × HER3 bispecific antibody (NRG1-fusion-targeted) |
|---|---|
| Mechanism | Humanized IgG1 bispecific antibody binding HER2 (one arm) and HER3 (other arm). Mechanism of action against NRG1-fusion-driven tumors: zenocutuzumab docks on HER2, blocks the NRG1-fusion ligand from engaging HER3, disrupting HER2-HER3 heterodimerization and downstream PI3K/AKT signalling. NRG1 fusions are rare (<1%) but occur across pancreatic, NSCLC, breast, cholangiocarcinoma, and other solid tumors. |
| Typical dosing | 750 mg IV q2 weeks until disease progression or unacceptable toxicity. Premedicate with antihistamine + acetaminophen ± corticosteroid for first infusion. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-29 |
Notes
eNRGy trial (NCT02912949): Phase II, NRG1-fusion-positive solid tumors (pan-tumor basket). NSCLC cohort: ORR 33%, mDOR 7.4 mo. Pancreatic adenocarcinoma cohort: ORR 40%, mDOR 7.4 mo. FDA accelerated approval Dec 2024 — confirmatory study required. NRG1 fusion testing requires RNA-based NGS (DNA NGS misses many fusions). Trial-source SRC for eNRGy not yet ingested into KB — FLAG for follow-up.
Used By
Regimens
REG-ZENOCUTUZUMAB-NRG1-NSCLC- Zenocutuzumab monotherapy (eNRGy) — NRG1-fusion+ NSCLC (pan-tumor activity)