FDA (The U.S. Food and Drug Administration) has granted accelerated approval to Merus N.V.’s bispecific antibody, Bizengri (zenocutuzumab-zbco), for the treatment of advanced unresectable or metastatic pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC) harboring neuregulin 1 (NRG1) gene fusions. This approval is specifically for patients whose disease has progressed following prior systemic therapy.
Source of information (ET Times) : https://health.economictimes.indiatimes.com/news/industry/us-fda-approves-merus-therapy-to-treat-lung-pancreatic-cancers/115987979?utm_source=latest_news&utm_medium=homepage
Mechanism of Action
Bizengri operates by inhibiting the interaction between the HER3 protein and the NRG1 gene, thereby disrupting tumor cell growth. By blocking the HER2/HER3 heterodimer formation, the drug effectively impedes oncogenic signaling pathways, leading to reduced tumor cell proliferation and survival.
FDA:Clinical Trial Evidence
The FDA’s decision is based on data from the phase 1/2 eNRGy trial, which evaluated the safety and efficacy of Bizengri in patients with NRG1+ cancers. In this study, the therapy demonstrated a 37.2% objective response rate (ORR) in NSCLC patients and a 42.4% ORR in pancreatic cancer patients. The clinical benefit rates were 61.5% and 72.7%, respectively. Notably, the median duration of response was 14.9 months for NSCLC and 9.1 months for pancreatic cancer, indicating durable efficacy.
Safety Profile
Safety data from the eNRGy trial indicated that treatment-emergent adverse effects (TEAEs) were manageable, with no patients discontinuing therapy due to TEAEs. Common adverse effects included diarrhea, infusion-related reactions, and fatigue. Importantly, no grade 5 treatment-related TEAEs were reported.
Regulatory Designations
Prior to approval, Bizengri received Breakthrough Therapy Designation from the fda for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer and NSCLC, following progression with prior systemic therapy. These designations facilitated an expedited review process, underscoring the therapy’s potential to address significant unmet medical needs.
Commercialization and Availability
Merus has announced that Bizengri will be available to patients in the coming weeks. The company has also entered into an agreement with Partner Therapeutics, granting them full rights to U.S. commercialization of Bizengri. This partnership aims to ensure broad access to the therapy for eligible patients.
Financial Projections
Analysts project that Bizengri could achieve peak global sales of approximately $462 million, reflecting the significant demand for effective treatments targeting NRG1+ cancers.
Conclusion
The FDA’s accelerated approval of Bizengri marks a significant advancement in the treatment of NRG1+ pancreatic adenocarcinoma and NSCLC. By specifically targeting the NRG1 gene fusion, Bizengri offers a novel therapeutic option for patients with limited alternatives, potentially improving outcomes in these challenging cancer types.
