**Merus N.V., a company specializing in oncology and working on groundbreaking, comprehensive, multispecific antibodies (Biclonics and Triclonics), announced the FDA’s nod for Bizengri (zenocutuzumab-zbco).** This milestone marks the first approved therapy for adults with advanced unresectable or metastatic pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) featuring an NRG1 gene fusion who have seen disease progression following previous systemic treatment. The approval is granted under accelerated conditions, based on the overall response rate (ORR) and duration of response (DOR), with the condition that ongoing studies continue to affirm and elaborate on its clinical benefits.
We believe this decision by the FDA addresses a critical gap for patients with NRG1-positive cancers, who have not had previously sanctioned therapies targeting this specific driver. Bizengri (zenocutuzumab-zbco) at 20 mg/mL for intravenous use is slated for patient availability in the upcoming weeks.
“The FDA’s authorization of Bizengri marks a pivotal achievement for patients with advanced unresectable or metastatic pancreatic adenocarcinoma or NSCLC with the NRG1 gene fusion,” stated Dr. Alison Schram, MD, of Memorial Sloan Kettering Cancer Center and a lead investigator in the ongoing eNRGy trial. “I’ve witnessed the significant and positive clinical outcomes Bizengri offers to patients, and am deeply thankful for all patients and families involved in the trial.”
“As Merus’s inaugural approved medication stemming from our unique Biclonics technology platform, Bizengri offers substantial promise for those with NRG1-positive pancreatic and lung cancer,” said Shannon Campbell, Merus’s chief commercial officer. “This endorsement attests to the potential of our technology and the robust application of our multispecific platforms and developing therapies, including our lead asset petosemtamab.”
The approval followed the eNRGy trial, a multi-center study examining patients with progressive advanced unresectable or metastatic NRG1-positive tumors after previous treatment. In the study, 30 patients with pancreatic adenocarcinoma showed a 40% (95% CI, 23%-59%) ORR, with DOR ranging from 3.7 to 16.6 months. For NSCLC patients (n=64), the trial reflected a 33% (95% CI, 22%-46%) ORR and a median DOR of 7.4 months (95% CI, 4.0-16.6). The outcomes adhered to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 via a blinded independent central review (BICR). Across a broader safety cohort (N=175), common adverse reactions included diarrhea, fatigue, and musculoskeletal pain among others, while notable severe laboratory irregularities (over 2%) involved elevated enzymes and decreased blood components.
Eduard Abrahams, President of the Personalized Medicine Coalition, commented, “The approval of Bizengri underscores the progress in personalized medicine, offering a singular approved NRG1+ therapy for these challenging cancers.”