Zenocutuzumab: A New Hope for NRG1 Fusion Cancers
Date: April 05, 2025
The FDA has granted accelerated approval to zenocutuzumab (Bizengri), making it the first targeted therapy for tumors carrying a rare genetic alteration known as NRG1 fusion.
Who Can Benefit?
This approval applies to patients with non-small cell lung cancer (NSCLC) or pancreatic cancer who tested positive for NRG1 fusions and whose disease progressed after prior standard therapies.
Understanding NRG1 Fusion
NRG1 fusions occur when the NRG1 gene abnormally joins with another gene, creating a fusion protein. This protein overactivates HER2and HER3 receptors, fueling cancer growth in a small percentage of patients.
Zenocutuzumab blocks the interaction between HER3 and the fusion protein, preventing the HER2/HER3 signaling that drives tumor development.
Clinical Trial Results
- 158 patients treated (93 NSCLC, 36 pancreatic cancer).
- Tumor response:
- NSCLC: 30% showed tumor shrinkage (median duration: 12.7 months)
- Pancreatic: 42% showed tumor shrinkage (median duration: 7.4 months)
- One complete response reported.
- Side effects mild: fatigue, nausea, diarrhea, and anemia. Only one discontinuation due to side effects.
Why It Matters
- Offers a new option for patients with limited treatments.
- Better safety profile than many conventional therapies.
- Step forward for precision oncology targeting rare mutations.
What’s Ahead?
Ongoing research is exploring:
- Long-term survival benefits.
- Factors influencing varied patient responses.
- Effectiveness of zenocutuzumab in other NRG1 fusion-positive cancers.
Experts also emphasize the importance of RNA-based testing, which is more sensitive than standard DNA testing in detecting NRG1 fusions. RNA profiling should be considered in cases of aggressive or rare cancers.
Published by:
Janan’s Realm – Cancer Watch Section
Medical insights curated by Dr. Jenan Khaled, Oncology Consultant
كاهنة الحيرة – د. جنان
www.janansrealm.com