Study
| Phase 2, open-label, multicenter clinical trial (eNRGy) |
| Advanced/metastatic solid tumors with NRG1 fusion |
| Zenocutuzumab 750 mg IV every 2 weeks |
Efficacy
| ORR: 30% (95% CI, 23–37) |
| CR: 1 pt |
| mDoR: 11.1 mos (95% CI, 7.4–12.9) |
| mPFS: 6.8 mos (95% CI, 5.5–9.1) |
| NSCLC ORR: 29% (95% CI, 20–39), mDoR: 12.7 mos (95% CI, 7.4–20.4) |
| Pancreatic cancer ORR: 42% (95% CI, 25–59), mDoR: 7.4 mos (95% CI, 4.0–11.2) |
Safety
| Grade ≥3 AEs: 14% |
| Most common grade ≥3 AEs: Anemia (5%), GGT increase (4%), pneumonia (3%) |
| Infusion-related reactions: 14% (all grade 1–2) |
| Treatment-related grade ≥3 AEs: 7% (most common: diarrhea, anemia—3% each) |
| Fatal AEs: 4% (none treatment-related) |
N Engl J Med 2025;392:566-576
Schram AM,Goto K,Kim DW Efficacy of Zenocutuzumab in NRG1 Fusion–Positive Cancer
http://doi.org/10.1056/NEJMoa2405008
Reviewed by Ulas D. Bayraktar, MD on Feb 7, 2025
