NEW YORK – Merus on Tuesday said the US Food and Drug Administration has extended the time it will take to review the firm's biologics license application (BLA), seeking approval for zenocutuzumab as a treatment for NRG1 fusion-positive non-small cell lung cancer and pancreatic ductal adenocarcinoma (PDAC).
Merus submitted its BLA to the FDA in May, and the agency had granted it priority review. Typically, the FDA aims to decide on an application under priority review in six months, compared to 10 months for a standard review. In this case, the agency extended the decision date for zenocutuzumab to Feb. 4, 2025, to allow more time to review chemistry, manufacturing, and controls information Merus had submitted at the FDA's request. The agency did not request any additional clinical data, according to Merus.
In its BLA, Merus submitted data from the Phase I/II eNRGy trial, in which it evaluated the safety and anti-tumor activity of the HER2/HER3-directed antibody in NRG1 fusion-positive NSCLC, PDAC, and other solid tumors. In June 2021, Merus presented the first readout from the trial, showing 13 patients out of 45 treated with zenocutuzumab responded and 34 had reductions in tumor size.
Then, at the European Society for Medical Oncology Congress last year, the firm released updated results from this trial. As of the data cutoff on July 31, 2023, the firm reported a 37 percent objective response rate to zenocutuzumab among 78 evaluable patients with NRG1 fusion-positive NSCLC patients and a median duration of response of 14.9 months. Among 33 evaluable NRG1 fusion-positive PDAC patients, 42 percent responded to the drug and the median duration of response was 9.1 months.
To be eligible for the trial, patients had to have locally advanced, unresectable, or metastatic solid tumors that were positive for NRG1 fusions. All patients had previously received treatment or were unable to receive standard therapy.
In a statement, the Utrecht, Netherlands-based company said that if the FDA approves zenocutuzumab, it will want to engage a commercialization partner to help bring it to market for patients with NRG1 fusion-positive cancer.