The phase 2 study evaluated 22 patients with advanced or metastatic disease, focusing on those whose tumors harbor NRG1 gene fusions. Among the 19 patients evaluable for efficacy, the investigator-assessed overall response rate reached 36.8%, with a median duration of response of 7.4 months. Clinical benefit, defined as a complete or partial response or stable disease for more than six months, was observed in 57.9% of participants.
New Data Validates Zenocutuzumab for Rare Bile Duct Cancer
Results from the eNRGy clinical trial, published in the Journal of Clinical Oncology, show that the targeted therapy zenocutuzumab provides durable antitumor activity for patients with NRG1 fusion-positive cholangiocarcinoma, a rare and aggressive form of bile duct cancer that has historically lacked effective treatment options.
These findings follow the recent U.S. Food and Drug Administration approval of the drug, marketed as BIZENGRI, for this specific patient population. Researchers highlighted that the trial results underscore the necessity of comprehensive molecular testing, specifically RNA-based next-generation sequencing, which identified 100% of the NRG1 fusions in the study compared to only 29% detected by DNA-based methods alone. The therapy was generally well-tolerated, with common adverse events limited to grade 1-2 side effects such as diarrhea, fatigue, and nausea, and no treatment discontinuations attributed to safety concerns.
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