Drug updated on 3/28/2025
| Dosage Form | Injection (intravenous; 375 mg/18.75 mL [20 mg/mL]) |
| Drug Class | Bispecific HER2- and HER3-directed antibody |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
- Indicated for the treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Among 158 patients with measurable advanced Neuregulin 1 (NRG1) fusion-positive solid tumors, zenocutuzumab demonstrated an Overall Response Rate (ORR) of 30% (95% Confidence Interval [CI]: 23 to 37), with a median Duration of Response (DoR) of 11.1 months (95% CI: 7.4 to 12.9); 19% of responses were ongoing at the data cutoff.
- The median Progression-Free Survival (PFS) for the same population was 6.8 months (95% CI: 5.5 to 9.1).
- In defined subgroups, response rates were 29% (95% CI: 20 to 39) among 93 patients with Non-Small Cell Lung Cancer (NSCLC) and 42% (95% CI: 25 to 59) among 36 patients with pancreatic cancer.
- Among patients with advanced NRG1 fusion-positive cancer, common Adverse Events (AEs) included diarrhea (18%), fatigue (12%), and nausea (11%); infusion-related reactions occurred in 14% of patients, with most AEs being grade 1 or 2.
- One patient discontinued zenocutuzumab due to a treatment-related adverse event (TRAE).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Bizengri (zenocutuzumab-zbco) Prescribing Information. | 2024 | Merus N.V. |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efficacy of Zenocutuzumab in NRG1 Fusion-Positive Cancer | Data not availableSubjects F: null% M: null% | 2025 | The New England Journal of Medicine |
Document Title
Sex Distribution:
Year:
2025
Source:The New England Journal of Medicine