FDA Grants Accelerated Approval for Merus' Bizengri to Treat NRG1+ Cancers

Merus' Bizengri (zenocutuzumab-zbco) has gained accelerated approval from the US Food and Drug Administration (FDA), representing a significant advancement in the treatment of cancers characterized by a neuregulin 1 (NRG1) gene fusion, as noted by the principal investigator of Merus' ongoing clinical study.

This approval marks the first time the FDA has given the green light to a systemic therapy aimed at treating advanced, unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that are NRG1-positive (NRG1+), specifically for patients whose disease has progressed after previous systemic therapies.

The eNRGy trial (NCT02912949), which played a crucial role in the accelerated approval, was a multicenter, open-label clinical study involving 30 patients with NRG1+ pancreatic adenocarcinoma and 64 patients with NRG1+ NSCLC. Among the pancreatic cancer group, an overall response rate (ORR) of 40% was observed, while the NSCLC group demonstrated an ORR of 33%.

Continued authorization for Bizengri’s use in treating NRG1+ lung and pancreatic cancers will depend on the verification and detailed description of its clinical benefits through confirmatory trials.

Dr. Alison Schram, the principal investigator of the eNRGy trial, remarked on the significance of the FDA’s approval of Bizengri for patients with advanced, unresectable, or metastatic pancreatic adenocarcinoma or NSCLC with the NRG1 gene fusion: "This represents an important milestone. I have witnessed firsthand the substantial clinical benefits that Bizengri can provide to patients."

Bizengri will soon be available as a 20mg/ml injection for intravenous administration. However, it comes with a boxed warning regarding potential risks such as embryo-fetal toxicity, infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD) or pneumonitis, and left ventricular dysfunction.

The FDA's approval was also preceded by Merus securing a commercial partner for Bizengri earlier in the same week. On December 2, the company announced an exclusive licensing agreement with Partner Therapeutics for the commercialization of the drug in the United States.

Merus’ Chief Commercial Officer Shannon Campbell commented on the approval, stating: "This achievement underscores our technological capabilities and successful execution as we continue developing our multispecific platforms and pipeline, including our leading asset, petosemtamab."

Additionally, Merus shared updated Phase II trial data for petosemtamab, which is under investigation for the treatment of head and neck squamous cell carcinoma. These findings were presented at the European Society for Medical Oncology (ESMO) Asia Congress on December 7.