FDA approval of Bizengri (zenocutuzumab-zbco) for NRG1+ pancreatic adenocarcinoma and NRG1+ non–small cell lung cancer (NSCLC)

These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Biznegri has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction. 

We believe this approval fills an important need for patients with NRG1+ cancer who have not previously had treatment options approved to specifically target this driver .Bizengri (zenocutuzumab-zbco) 20 mg/mL Injection for Intravenous Use is expected to be available to patients in the coming weeks.

“The FDA approval of Bizengri marks an important milestone for patients with pancreatic adenocarcinoma or NSCLC that is advanced unresectable or metastatic and harbors the NRG1 gene fusion. I have seen firsthand how treatment with Bizengri  can deliver clinically meaningful outcomes for patients,” said Alison Schram, MD, an attending medical oncologist in the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and a principal investigator for the ongoing eNRGy trial. “I am extraordinarily grateful for the patients and families who participated in the trial.”

“Bizengri is Merus’s first approved medicine based on our highly innovative and proprietary Biclonics  technology platform and offers significant promise for patients with NRG1+ pancreatic adenocarcinoma and NRG1+ NSCLC,” said Shannon Campbell, Chief Commercial Officer of Merus. “This approval is a testament to both our technology and strong execution as we continue to develop our multispecific platforms and pipeline, including our lead asset petosemtamab.” 

The approval of Bizengri is based on data from the eNRGy trial, a multicenter, open-label clinical trial that enrolled patients with NRG1+ pancreatic adenocarcinoma or NRG1+ NSCLC that is advanced unresectable or metastatic and had disease progression on or after prior systemic therapy. In patients with NRG1+ pancreatic adenocarcinoma (n=30), Bizengri demonstrated an ORR of 40% (95% CI, 23%-59%). DOR in NRG1+ pancreatic adenocarcinoma ranged from 3.7 months to 16.6 months. In the same trial, patients with NRG1+ NSCLC (n=64) who were treated with Bizengri  demonstrated an ORR of 33% (95% CI, 22%-46%). The median DOR in NRG1+ NSCLC was 7.4 months (95% CI, 4.0-16.6). Response rates were measured using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR).

In the pooled safety population (N=175), the most common (≥10%) adverse reactions were diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions (IRR), dyspnea, rash, constipation, vomiting, abdominal pain, and edema. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were increased gamma-glutamyltransferase, decreased hemoglobin, decreased sodium, decreased platelets, increased aspartate aminotransferase, increased alanine aminotransferase, increased alkaline phosphatase, decreased magnesium, decreased phosphate, increased activated partial thromboplastin time, and increased bilirubin.

“The Personalized Medicine Coalition applauds the approval of Bizengri, a new targeted therapy for NRG1+ pancreatic adenocarcinoma and NRG1+ NSCLC that are advanced unresectable or metastatic,” said Edward Abrahams, President of the Washington-based education and advocacy organization. “In keeping with the growing number of personalized medicines on the market today, Bizengri offers the only approved NRG1+ therapy for patients with these difficult-to-treat cancers.”

The company plans to help appropriate patients gain access to Bizengri  by providing resources and support based on each patient's needs and situation. PTx Assist is available to help guide patients through treatment, from providing educational information to helping to understand insurance coverage and identifying potential financial assistance options. For more information, patients and providers can call 1-844-637-8777, Monday through Friday, from 8:00 a.m. to 8:00 p.m. ET.