Merck & Co. (MRK) said Thursday that it has voluntarily withdrawn its biologics license application with Daiichi Sankyo seeking approval for patritumab deruxtecan in the US.
The application was based on the HERTHENA-Lung01 phase 2 trial for the treatment of certain adult patients with non-small cell lung cancer.
The company said it decided to withdraw the application because the topline overall survival results from the confirmatory HERTHENA-Lung02 phase 3 trial did not meet statistical significance.