Zenocutuzumab for NRG1-Positive Cholangiocarcinoma
Clinical Summary:
- Design/Context: The phase 2 eNRGy study evaluating zenocutuzumab, a HER2/HER3 bispecific antibody, in patients with NRG1 fusion–positive advanced solid tumors, including cholangiocarcinoma.
- Key Outcomes: Zenocutuzumab demonstrated meaningful response rates, durable clinical benefit, and favorable tolerability in heavily pretreated patients with cholangiocarcinoma.
- Clinical Relevance: These results led to FDA approval of zenocutuzumab and establish a targeted treatment option for patients with NRG1 fusion-positive cholangiocarcinoma.
Alison Schram, MD, Memorial Sloan Kettering Cancer Center, New York, New York, discusses results from the phase 2 eNRGy trial evaluating zenocutuzumab in patients with NRG1-fusion positive cholangiocarcinoma.
Results demonstrated that zenocutuzumab showed meaningful and durable antitumor activity with a favorable safety profile, with most adverse events limited to grade 1/2 severity. This data supported the recent FDA approval of zenocutuzumab for patients with NRG1 fusion-positive cholangiocarcinoma.
Source:
Schram A, Cleary JM, Arnold D, et al. Zenocutuzumab efficacy and safety in advanced NRG1+ cholangiocarcinoma: Analysis from the phase 2 eNRGy trial. Presented at the 2025 International Conference on Molecular Targets and Cancer Therapeutics. October 22-26; Boston, Massachusetts. A102.
