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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Monday, May 5, 2025
Zenocutuzumab, a first-in-class HER2- and HER3-targeted bispecific antibody, demonstrated benefit in NRG1 fusion–positive cancers, particularly non–small cell lung cancer (NSCLC) and pancreatic cancer, according to results from the phase II eNRGy trial published in the New England Journal of Medicine.
The study enrolled 204 patients with 12 tumor types of advanced NRG1 fusion–positive cancer to receive a 750-mg dose of zenocutuzumab intravenously every 2 weeks.
Among evaluable patients, the response rate was 30% (95% confidence interval [CI] = 23–37) and the median duration of response was 11.1 months (95% CI = 7.4–12.9 months). Nineteen percent of responses were ongoing at data cutoff. The median progression-free survival was 6.8 months (95% CI = 5.5–9.1 months).
Responses were observed in 29% of patients with NSCLC and in 42% of patients with pancreatic cancer. Responses were also seen across multiple NRG1 fusion partners.
The most common adverse events that were potentially related to treatment were diarrhea in 18% of patients, fatigue in 12%, and nausea in 11%; infusion-related reactions were reported in 14% of patients.
“This study validates NRG1 fusions as an actionable therapeutic target,” concluded the study authors, led by Alison M. Schram, MD, Medical Oncologist, Early Drug Development and Gynecologic Malignancies, Memorial Sloan Kettering Cancer Center.
Disclosure: For full disclosures of the study authors, visit www.nejm.org.
New England Journal of Medicine
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