FDA Approves Zenocutuzumab in NSCLC/Pancreatic Cancer

Zenocutuzumab is now approved for patients with NRG1 NSCLC or NRG1 pancreatic adenocarcinoma.

The FDA has approved zenocutuzumab-zbco (Bizengri) for patients with advanced, unresectable, or metastatic non–small cell lung cancer (NSCLC) who have NRG1 gene fusion with disease progression on or after systemic therapy or advanced unresectable or metastatic pancreatic adenocarcinoma with an NRG1 gene fusion on or after prior systemic therapy.¹

The approval is based on results from the phase 2 eNRGy trial (NCT02912949) assessing 64 patients with NRG1 fusion-positive NSCLC and 30 patients with NRG1 fusion-positive pancreatic adenocarcinoma.² The recommended dose of zenocutuzumab is 750 mg as an intravenous infusion every 2 weeks.

Topline data for patients with NSCLC showed a confirmed objective response rate (ORR) of 33% (95% CI, 22%-46%) and a median duration of response (DOR) of 7.4 months (95% CI, 4.0-16.6). For patients with pancreatic adenocarcinoma, the ORR was 40% (95% CI, 23%-59%), and the DOR range was 3.7 months to 16.6 months.

The most common grade 3/4 adverse effects included increased gamma-glutamyl transferase, decreased hemoglobin, decreased sodium, and decreased platelets.

References

1. FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma. News release. FDA. December 4, 2024. Accessed December 4, 2024. https://shorturl.at/E3HBS
2. Schram A, Macarulla T, Cleary J, et al. 1618P Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC). Ann Oncol. 2023;34(suppl 2):S895-S896. doi:10.1016/j.annonc.2023.09.2567