The U.S. Food and Drug Administration (FDA) has awarded breakthrough therapy designation to zenocutuzumab (MCLA-128), a potential treatment for patients with advanced unresectable or metastatic NRG1 fusion-positive pancreatic cancer who have shown disease progression on previous systemic therapy or have limited treatment options available.
Early access program (EAP) results and data from the phase 1/2 eNRGy trial (NCT02912949) substantiate this designation. The CEO of Merus NV, Bill Lundberg, MD, mentioned in a press release that the compelling clinical data for zenocutuzumab in NRG1-positive cancer and breakthrough designation allows them to further engage with the FDA to speed up the potential biologics license application submission.
The phase ½ trial’s primary endpoint was the investigator-assessed ORR, with encouraging responses observed in pancreatic ductal adenocarcinoma and non-small cell lung cancer patients, and the trial findings indicate that zenocutuzumab was well-tolerated, with most patients experiencing all-grade treatment-related adverse events.
Merus is presently evaluating the zenocutuzumab and Gilotrif combo in NRG1-positive NSCLC patients, and the company will be providing a clinical update at an upcoming medical conference on the agent in NRG1-positive cancers.
Source: Zenocutuzumab (Zeno) granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration for the treatment of NRG1+ pancreatic cancer.
https://ir.merus.nl/news-releases/news-release-details/zenocutuzumab-zeno-granted-breakthrough-therapy-designation-us
