Zenocutuzumab demonstrated clinically meaningful and durable antitumor activity in patients with advanced NRG1-fusion positive cholangiocarcinoma, with an objective response rate of 36.8% and median progression-free survival of 9.2 months. The drug had a favorable safety profile, with most treatment-related adverse events being grade 1 or 2, and no patients discontinuing treatment due to adverse events.
Study
|
Single-arm, phase 2 study [eNRGy] |
| Advanced NRG1-fusion positive cholangiocarcinoma (n=22) |
| Zenocutuzumab every 2 weeks
|
Efficacy
|
ORR: 36.8% (95% CI, 16.3 to 61.6) |
| mDOR: 7.4 mos (95% CI, 4.6 to NE) |
| mPFS: 9.2 mos (95% CI, 3.9 to 11.1) |
| mOS: Not reached (95% CI, 16.1 mos to NE) |
| 12-month OS: 82.6% (95% CI, 55.2 to 94.1) |
| 24-month OS: 54.2% (95% CI, 16.5 to 81.2)
|
Safety
|
Grade >=3 TRAEs: anemia (4.5%) |
| No patients discontinued treatment due to an AE
|
J Clin Oncol. Published online July 1, 2026
http://doi.org/10.1200/JCO-25-03128
Reviewed by Ulas D. Bayraktar, MD on Aug 13, 2026
