Study: FDA approves new targeted therapy for advanced pancreatic cancer
A new treatment called Bizengri has been approved by the FDA for patients with advanced or metastatic pancreatic cancer. This treatment targets pancreatic cancer or non-small cell lung cancers that have a rare tumor mutation called an NRG1 fusion. (Posted 7/24/25)
RELEVANCE
Most relevant for: People with advanced, unresectable, or metastatic pancreatic cancer or NSCLC.
It may also be relevant for:
- people with pancreatic cancer
Relevance: Medium-High
Strength of Science: High
Research Timeline: Post Approval
What is this study about?
The main goal of this study was to determine whether Bizengri (zenocutuzumab-zbco), a new , could help people with pancreatic cancer live longer without their cancer growing.
Based on the findings of this study, the U.S. Food and Drug Administration () approved Bizengri for treating pancreatic cancers that have a known as an NRG1 gene fusion. Among people whose pancreatic cancer had this rare mutation, treatment extended the time until the cancer came back or got worse.
Why is this study important?
Pancreatic cancer is difficult to diagnose early. Signs or symptoms don’t often appear in the early stages of this disease. Pancreatic cancer symptoms typically appear after the cancer has advanced. Most pancreatic cancers are diagnosed at late stages, frequently when the cancer has already spread to other parts of the body.
Once diagnosed, pancreatic cancer is difficult to treat. Standard treatment may include surgery, radiation, chemotherapy or a combination of these. If these standard treatments don’t work, targeted therapies like Bizengri provide another option.
The accelerated approval for Bizengri to treat people with pancreatic or non-small cell lung cancer (NSCLC) whose tumors have an NRG1 fusion and whose disease has worsened, despite standard treatments. NRG1 fusions occur in under 1% of pancreatic cancers but can be difficult to treat when present. Bizengri is the first targeted treatment for cancers with an NRG1 fusion mutation.
Study findings
Approval of Bizengri was based on the results from the eNRGy trial. The trial included 158 participants with measurable cancers. All participants had a tumor with an NRG1 fusion and prior cancer treatment.
Participants received Bizengri through a vein (by IV) every two weeks until their cancer progressed or they withdrew from the study.
About one-third of all participants had tumors that shrank or stopped growing for 11 months, on average. Below is a breakdown for each group:
- Participants with pancreatic cancer: 42% had cancers that shrank or stopped growing, with an average duration of about 7.5 months.
- Participants with NSCLC: About 30% had cancers that shrank or stopped growing, with an average duration of almost 7 months.
- One person with gastric cancer, one with ovarian cancer and one with breast cancer had a partial response to Bizengri. Because only a few people with these cancers were included in this study, more research is needed to understand if Bizengri can help treat these cancers.
| Cancer | Number of participants in study | Number of participants whose cancer responded to Bizengri | Percentage of participants whose cancer responded to Bizengri |
| All cancers | 158 | 47 | 30% |
| Non-small cell lung cancer | 93 | 27 | 29% |
| Pancreatic cancer | 36 | 15 | 42% |
| Bile duct cancer | 10 | 2 | 20% |
| Breast cancer | 7* | 1 | ** |
| Colorectal cancer | 6 | 0 | ** |
| Endometrial cancer | 1* | 0 | ** |
| Gastric cancer | 1* | 1 | ** |
| Ovarian cancer | 1* | 1 | ** |
| Unknown origin | 2 | 0 | ** |
Side effects
Most participants (95%) experienced at least one side effect that was mostly mild or less severe (grade 1 or 2). The most common grade 1 or 2 side effects of Bizengri were:
- Diarrhea
- Fatigue
- Nausea
- Anemia
About 7% of participants experienced more severe side effects (grade 3 or 4), which included:
- Severe anemia
- Severe diarrhea
None of these side effects resulted in a participant stopping treatment or in death.
What does this mean for me?
The approval of Bizengri offers a new treatment option for a small subset of pancreatic cancer patients who previously had limited choices. As researchers learn more about the tumor mutations in pancreatic cancers, new targeted treatments like Bizengri offer promising options.
Tumor testing can detect changes in a cancer that may guide selection of the most effective treatment. Not all tests are the same. An “RNA sequencing” test is recommended to find these rare NRG1 fusion tumor mutations. If you have pancreatic cancer, ask your doctor about testing that includes RNA sequencing to determine if you are a candidate for treatment with Bizengri.
Genetic testing for inherited mutations is recommended for all pancreatic cancer patients, as it can help identify people who may be candidates for a , a clinical trial or other appropriate treatment options.
More information on Bizengri and other targeted and immunotherapies for pancreatic cancer can be found here.
Reference
Schram A, Goto K, Kim D-W et al. Efficacy of Zenocutuzumab in NRG1 Fusion–Positive Cancer. New England Journal of Medicine. 2025; 392:566-576.
Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to ensure scientific integrity.
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posted 7/24/25
Questions To Ask Your Doctor
- Have I had tumor testing?
- If I haven’t had tumor testing, can you order it for me?
- If I had tumor testing, what were the results and what do they mean?
- Did my tumor testing include RNA sequencing for changes like an NRG1 fusion?
- Is Bizengri a treatment option for me? Why or why not?
- What are the risks and benefits of Bizengri treatment? What are the possible side effects?
Guidelines
National Comprehensive Cancer Network (NCCN) guidelines recommend the following for people diagnosed with pancreatic cancer:
- Receive treatment from a team of healthcare professionals that includes a variety of experts in cancer care, genetics, mental health, nutrition and management of side effects. These experts are more likely to be found at large cancer centers that have extensive experience treating pancreatic cancer.
- Make sure you have had the following tests:
- Genetic testing for an . Genetic test results may help you and your doctor decide on the best treatment. Genetic test results may also help your relatives understand their risk for cancer.
- Imaging tests to learn the of your cancer. is needed to plan and monitor your treatment. These tests determine whether the tumor can be removed with surgery (it is resectable), if the cancer has spread to nearby organs or (it is locally advanced) or has spread to other parts of the body (it has metastasized).
- Tumor testing for people with locally advanced or pancreatic cancer can also be used to make treatment decisions and/or determine if you are eligible for clinical trials.
- Keep a copy of all test results (online patient portals are a great way to access test results). This will come in handy during a second opinion, if necessary.
- Discuss with your healthcare team whether chemotherapy is recommended before and/or after your surgery.
Updated: 05/24/2025
Open Clinical Trials
The following treatment studies are enrolling people diagnosed with pancreatic cancer.
- NCT06545942: Treating Advanced Cancers with DNA-Repair Mutations Using MOMA-313 Alone or In Combination with the Olaparib. This trial studies an investigational drug called MOMA-313 given alone or together with the olaparib for people with advanced cancers, including pancreatic cancer with certain mutations.
- NCT04548752: Adding Pembrolizumab to to Treat Pancreatic Cancer in People with an Inherited Mutation. This study researches whether adding the drug pembrolizumab to the olaparib works better than alone for treating pancreatic cancer in people with an inherited or mutation.
- NCT06115499: Treating BRCA1, or Pancreatic Cancer Using a New Combination of Chemotherapy Drugs. This study will compare a 3-drug chemotherapy combination (NABPLAGEM; gemcitabine, cisplatin, nab-paclitaxel) to a 2-drug chemotherapy combination (gemcitabine/nab-paclitaxel) to treat people with pancreatic cancer with a , or mutation who have pancreatic cancer that has progressed after chemotherapy.
- NCT04858334: or in Patients with Surgically Removed Pancreatic Cancer who have a , or Mutation (APOLLO). This study compares the usual approach (observation) to treatment for one year with in patients with a , or mutation.
- NCT04550494: Treating Solid Tumors with an Inherited or Acquired Gene Mutation Using the Talazoparib. This study looks at the safety and effectivenss of the drug for treating people with advanced breast, gastric, ovarian, pancreatic or other cancers with an or an acquired mutation in certain repair genes, such as , , , , and others.
- NCT05932862: Study of a New InvestigationaI Inhibitor to Treat People with Advanced . The study will test if an investigational treatment, XL309, is safe and works when used alone or in combination with a to treat people with advanced cancers, including pancreatic cancer.
- NCT04150042: SHARON: A Clinical Trial for Cancer With an Inherited or Mutation Using Chemotherapy and Patients’ Own Stem Cells. This study looks at whether melphalan, BCNU, vitamin B12b and vitamin C followed by autologous (self) bone marrow stem cell infusion is safe and effective for treating patients with advanced pancreatic cancer or 4, breast cancer for people with a , or .
Other clinical trials for people with pancreatic cancer can be found here.
Updated: 05/24/2025
Related Resources
The following resources may be helpful for people with pancreatic cancer.
- FORCE resources:
- The following resources from other organizations are for people who have been diagnosed with pancreatic cancer:
- PanCAN is a nonprofit organization that provides support for pancreatic cancer patients.
- Let's Win PC is a nonprofit organization that enables doctors, scientists and patients to share fast-breaking information on potentially life-saving pancreatic cancer treatments and clinical trials.
- The Healing NET Foundation is a nonprofit organization for people with neuroendocrine cancers.
- The Neuroendocrine Cancer Awareness Network (NCAN) is a non-profit organization dedicated to raising awareness of neuroendocrine cancer and providing support for caregivers and people with NETs.
Updated: 09/18/2024