Merus N.V. announced that the New England Journal of Medicine (NEJM) published positive results from the phase 2 eNRGy trial of Bizengri (zenocutuzumab) for treating advanced NRG1 fusion-positive pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC). This marks the first approved therapy specifically targeting this rare genetic alteration, addressing an unmet medical need for these patient populations. The license for commercializing Bizengri in the U.S. has been granted to Partner Therapeutics, Inc.
This publication is a major milestone for the oncology field. It validates NRG1 fusions as viable drug targets and offers a new treatment option for patients with these difficult-to-treat cancers who previously lacked targeted therapies. The NEJM publication lends significant credibility to Bizengri, potentially encouraging earlier diagnosis of NRG1 fusions and broader adoption of this targeted treatment.
The eNRGy trial demonstrated Bizengri’s efficacy across various tumor types, with particularly promising results in NSCLC and pancreatic adenocarcinoma. The therapy showed a favorable safety profile, although potential side effects like infusion-related reactions and interstitial lung disease were noted. The study enrolled 204 patients with 12 different tumor types, providing a comprehensive assessment of Bizengri’s activity and safety profile. Detailed results for the NSCLC and pancreatic cancer cohorts, including overall response rate and duration of response, are highlighted in the publication.
The NEJM publication and the partnership with Partner Therapeutics positions Bizengri for a successful U.S. launch. This could stimulate further research into NRG1 fusion biology and the development of additional therapies targeting this pathway. The availability of a targeted treatment like Bizengri is likely to improve outcomes and quality of life for patients with NRG1 fusion-positive cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
