In the evolving landscape of precision oncology, targeting specific genetic alterations has become a cornerstone of cancer treatment. A recent phase II study investigated the efficacy of zenocutuzumab, a HER2/HER3 bispecific antibody, in patients with NRG1 fusion-positive solid tumours.1
The eNRGy study, a registrational phase II clinical trial, enrolled patients with advanced NRG1 fusion-positive cancer across multiple tumour types. Patients received zenocutuzumab at a dose of 750 mg intravenously every two weeks. The primary endpoint was overall response (complete or partial response) as assessed by investigators. Secondary endpoints included duration of response, progression-free survival, and safety assessments. The study’s tumour-agnostic approach allowed for the inclusion of various cancer types, reflecting the diverse nature of NRG1 fusions.
The study enrolled 204 patients with 12 different tumour types, with the majority having non-small-cell lung cancer (NSCLC) or pancreatic adenocarcinoma. Among the 158 patients with measurable disease, the overall response rate was 30%, with a median duration of response of 11.1 months. Notably, responses were observed across multiple tumour types, including NSCLC and pancreatic cancer, where response rates were 29% and 42%, respectively. Median progression-free survival was 6.8 months. The treatment was generally well-tolerated, and adverse events were predominantly grade 1 or 2. The most common treatment-related adverse events of any grade were diarrhoea (18%), fatigue (12%), and nausea (11%). Only one patient discontinued treatment due to a treatment-related adverse event, underscoring the manageable safety profile of zenocutuzumab.
Zenocutuzumab demonstrated efficacy and a favourable safety profile in patients with advanced NRG1 fusion-positive cancer, particularly in NSCLC and pancreatic adenocarcinoma.
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