ENRGY-PANC
Regimen
- Experimental
- Zenocutuzumab (HER2 × HER3 bispecific antibody) 750 mg IV Q2W
- Control
- single-arm / no comparator (historical benchmark for chemo-refractory NRG1+ PDAC = dismal, few meaningful responses)
Population
Advanced NRG1 fusion-positive solid tumors (158 pts primary efficacy population across 10 tumor types; PDAC cohort n=36 — second-largest after NSCLC n=94). NRG1 fusions occur in ~0.5-1.5% of PDAC, enriched in KRAS WT PDAC. Global.
Key finding
FDA accelerated approval December 2024 for NRG1 fusion-positive advanced PDAC and NSCLC — the first biomarker-matched targeted therapy approved for PDAC that is not chemo (after olaparib). 42% ORR in a KRAS-WT, fusion-defined subset of PDAC where salvage chemo ORR is near zero. Validates the 'rare but actionable' fusion paradigm in PDAC that parallels NTRK, ROS1, ALK stories in other tumors.
Source: PMID 39908431