BIZENGRI is an innovative treatment for adults with advanced or metastatic cancers, specifically non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma, that harbor an NRG1 gene fusion. This targeted therapy offers hope for patients whose disease has progressed despite prior treatments. BIZENGRI was approved on December 4, 2024.

What is the name of the drug, and what does it do?

BIZENGRI (pronounced bi-ZEN-gree) is a bispecific antibody that targets two proteins, HER2 and HER3, which are often involved in cancer growth. By blocking these proteins and preventing them from working together, the drug inhibits tumor growth and helps destroy cancer cells.

How does it work?

BIZENGRI binds to the HER2 and HER3 proteins, stopping them from forming a pair (dimer) that triggers cancer cell growth. It also prevents the NRG1 protein from activating HER3, cutting off signals that would normally promote tumor growth. Additionally, BIZENGRI recruits the immune system to attack the cancer cells directly, enhancing its effectiveness.

What did the research discover?

In clinical trials, BIZENGRI demonstrated strong results for patients with advanced cancers carrying an NRG1 gene fusion. Among patients with NSCLC, the overall response rate (ORR) was 33%, meaning one-third of patients experienced significant tumor shrinkage. The median duration of response was 7.4 months, with 43% maintaining their response for at least six months. In patients with pancreatic cancer, the ORR was 40%, with 67% maintaining their response for six months or longer. These findings highlight BIZENGRI’s potential to control tumor growth and improve outcomes for patients with limited treatment options.

What are some of the side effects?

The most common side effects of BIZENGRI include:

  • Diarrhea
  • Muscle or bone pain
  • Fatigue
  • Nausea
  • Rash
  • Constipation
  • Vomiting
  • Abdominal pain
  • Swelling in the face, legs, or other areas

More serious side effects, though rare, include infusion-related reactions, lung inflammation (pneumonitis), and heart problems. Patients are closely monitored during treatment to manage any adverse effects.

What are the dosage recommendations, and how is it prescribed?

BIZENGRI is given as an intravenous (IV) infusion every two weeks. Each dose is carefully prepared and administered over four hours in a medical setting to ensure patient safety. Before each infusion, patients receive medications to reduce the risk of infusion-related reactions. Treatment continues until the disease progresses or side effects become unmanageable.

Source

Merus N.V. Prescribing information for BIZENGRI (zenocutuzumab-zbco). December 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761352s001lbl.pdf

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