Holland-based Merus N.V. (NASDAQ: MRUS) has announced that it has received FDA approval for its bispecific antibody (BsAb), Bizengri (zenocutuzumab-zbco), targeting HER2 and HER3 for the treatment of adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that are advanced, unresectable, or metastatic and harbor a neuregulin 1 (NRG1) gene fusion. These patients must have experienced disease progression on or after prior systemic therapy.
Positive Results from the eNRGy Trial
The FDA’s endorsement is supported by positive results from the eNRGy trial, which demonstrated an objective response rate (ORR) of 40% (95% CI, 23%-59%) and a duration of response (DOR) of 16.6 months in 30 patients with NRG1+ pancreatic adenocarcinoma treated with zenocutuzumab. In the same trial, 64 patients with NRG1+ NSCLC treated with the drug showed an ORR of 33% (95% CI, 22%-46%) and a median DOR of 7.4 months (95% CI, 4.0-16.6). The drug’s safety and tolerability were also confirmed in the study.
Commercialization Rights and Partnership
Previously, Merus out-licensed the commercialization rights to Bizengri in the US to Partner Therapeutics, a strategic move to expand the drug’s reach and ensure its availability to patients in need.-Fineline Info & Tech
