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Zenocutuzumab monotherapy (eNRGy) — NRG1-fusion+ NSCLC (pan-tumor activity)

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Source YAML: complete record

ComponentsDRUG-ZENOCUTUZUMAB
IDREG-ZENOCUTUZUMAB-NRG1-NSCLC
TypeRegimen
Statusreviewed 2026-04-29 | pending_clinical_signoff
DiseasesNone declared
SourcesSRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-NSCLC-2025

Notes

eNRGy (phase I/II pan-tumor, n=204): zenocutuzumab is a HER2 x HER3 bispecific that uniquely blocks NRG1-driven HER3 dimerization. NSCLC (n=93) ORR 37.2%, mDOR 14.9 mo, mPFS 6.8 mo. Pancreatic adenocarcinoma (n=36) ORR 42%. Activity independent of fusion partner. FDA approval 2024-12 covers BOTH NSCLC and pancreatic. NRG1 fusion prevalence ~0.2% pan-cancer; testing gap is the practical bottleneck — DNA-only NGS routinely misses NRG1 (large intronic breakpoints), RNA fusion assays required. This file is NSCLC-anchored (~46% of treated population); same regimen applies to NRG1-fusion+ pancreatic and other solid tumors. Generally well-tolerated; infusion reactions + diarrhea + fatigue are dominant AEs; rare LVEF decreases.

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