FDA Approves Zenocutuzumab for Patients With NRG1 Fusion-Positive Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma
On December 4th, 2024, the US Food and Drug Administration (FDA) approved zenocutuzumab for adult patients with advanced, unresectable, or metastatic neuregulin 1 (NRG1) fusion-positive non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma who have experienced disease progression on or after prior systemic therapy. This approval was based on results from the eNRGy study.
In this multicenter, open-label, multi cohort trial, researchers enrolled 94 patients with advanced or metastatic NRG1 fusion-positive NSCLC (n = 64) and pancreatic adenocarcinoma (n = 30) who had experienced disease progression following standard treatment to receive intravenous zenocutuzumab every 2 weeks until disease progression or unacceptable toxicity. Next-generation sequencing was used to determine NRG1 gene fusion status. Primary end points included overall response rate (ORR) and duration of response (DOR), assessed via blinded independent central review. A key secondary end point was safety.
Among patients with NSCLC, the ORR was 33% and the median DOR was 7.4 months. Among patients with pancreatic adenocarcinoma, the ORR was 40% and the DOR range was 3.7 months to 16.6 months. The most common adverse reactions occurring in ≥ 10% of patients included diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema. The most common grade 3/4 laboratory abnormalities occurring in ≥ 10% of patients included increased gamma-glutamyl transferase, decreased hemoglobin, decreased sodium, and decreased platelets.
The recommended dose of zenocutuzumab is 750 mg every 2 weeks until disease progression or unacceptable toxicity. This prescribing information comes with a Boxed Warning for embryo-fetal toxicity.
Source:
FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma. Accessed on December 4, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zenocutuzumab-zbco-non-small-cell-lung-cancer-and-pancreatic
