FDA Approves Merus' Bizengri for NRG1 Fusion-Positive Cancers
The U.S. Food and Drug Administration (FDA) has approved Merus N.V.'s Bizengri (zenocutuzumab-zbco) as the first and only treatment for adults with advanced, unresectable, or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion. This approval applies to patients who have experienced disease progression on or after prior systemic therapy.
Bizengri is the first approved medicine developed using Merus's proprietary Biclonics technology platform. This approval is based on data from the eNRGy trial, which demonstrated an overall response rate (ORR) of 40% in patients with NRG1+ pancreatic adenocarcinoma (n=30) and 33% in patients with NRG1+ NSCLC (n=64). The median duration of response (DOR) ranged from 3.7 to 16.6 months in pancreatic adenocarcinoma and was 7.4 months in NSCLC.
Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Bizengri 20 mg/mL Injection for Intravenous Use is expected to be available to patients in the coming weeks.
Analysts expect investor focus to remain on petosemtamab, with updated data for this drug in previously treated head and neck squamous cell carcinoma (HNSCC) expected at ESMO Asia on December 7. They estimate Bizengri will be priced at roughly $30,000 per treatment and project combined peak U.S. sales in NRG1 fusion NSCLC and PDAC attributable to Merus (based on an estimated 8% royalty rate) of roughly $16.5 million.