Bizengri A Breakthrough Targeted Therapy For NRG1 Fusion-Positive Cancers

Bizengri represents a paradigm shift in treating NRG1+ cancers, offering hope for patients with historically poor prognoses.

As precision medicine advances, RNA-based testing for NRG1 fusions will be crucial to identify eligible candidates.

With ongoing research, Bizengri may soon expand to other cancer types, further solidifying its role in oncology.

FDA Grants Bizengri Accelerated Approval

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Bizengri® (zenocutuzumab-zbco), a first-in-class bispecific antibody, for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma harbouring NRG1 gene fusions.

This marks the first FDA-approved therapy specifically targeting NRG1+ cancers, addressing a critical unmet need for patients with these rare but aggressive tumours.

The approval, announced on December 4, 2024, was based on data from the eNRGy trial (NCT02912949), which demonstrated significant tumor shrinkage in a subset of patients who had exhausted standard treatment options.

Mechanism Of Action: Targeting HER2/HER3 Signaling

Bizengri works by blocking the interaction between HER2 and HER3, two proteins that form a cancer-promoting complex when activated by NRG1 fusion proteins.

NRG1 fusions are rare genomic alterations that drive uncontrolled cell growth by triggering HER2/HER3 dimerization and downstream signaling pathways.

Unlike traditional chemotherapy, Bizengri is a bispecific antibody that specifically inhibits this interaction, thereby suppressing tumor proliferation.

Preclinical studies also suggest that the drug induces antibody-dependent cellular cytotoxicity (ADCC), further enhancing its antitumor effects.

Clinical Efficacy: Durable Responses In Resistant Cancers

The eNRGy trial, a global phase 2 study, enrolled 204 patients with NRG1+ solid tumors, including 64 with NSCLC and 30 with pancreatic cancer. Key findings include:

• NSCLC cohort: 33% overall response rate (ORR), with a median duration of response (DOR) of 7.4 months.
• Pancreatic cancer cohort: 40% ORR, with responses lasting between 3.7 and 16.6 months.
• One patient achieved a complete tumor disappearance, while others experienced sustained tumor shrinkage.

Despite the relatively low response rate, experts emphasize that Bizengri offers a meaningful benefit for patients with otherwise limited treatment options.

Safety Profile: Manageable Side Effects

Bizengri has demonstrated a favorable safety profile, with most adverse events being mild to moderate. Common side effects include:

• Diarrhea, fatigue, nausea, and musculoskeletal pain (occurring in ≥20% of patients).
• Infusion-related reactions (13%), mostly during the first administration.
• Rare but serious risks, such as interstitial lung disease (ILD) and left ventricular dysfunction.

The FDA has issued a Boxed Warning for embryo-fetal toxicity, advising strict contraception measures for women of reproductive potential.

Future Directions And Accessibility

While Bizengri’s approval is a milestone, confirmatory trials are required to verify its clinical benefits under the FDA’s accelerated pathway.

Researchers are also investigating combination therapies and exploring why some patients do not respond to treatment.

Partner Therapeutics, which holds U.S. commercialization rights, has launched PTx Assist™, a support program to help patients access Bizengri, including insurance navigation and financial assistance.

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