Pharmaceutical companies Merck & Co. and Daiichi Sankyo have withdrawn their Biologics License Application (BLA) for patritumab deruxtecan, an antibody-drug conjugate targeting HER3 in non-small cell lung cancer patients who’ve been previously treated with two or more systemic therapies.
The decision follows topline overall survival results from the phase 3 HERTHENA-Lung02 trial, which showed that overall survival didn’t meet statistical significance. The companies cited discussions with the FDA as a reason for their choice to withdraw the filing.
A separate confirmatory study is testing patritumab deruxtecan as a monotherapy versus doublet chemotherapy in patients with EGFR-mutated NSCLC after disease progression. Last year, Daiichi Sankyo received a complete response letter from the FDA related to manufacturing concerns, prompting the companies’ initial attempt to address these issues.
Despite this setback, execs for Daiichi and Merck expressed their continued interest in developing patritumab deruxtecan. The drug is one of three ADC assets that Merck paid Daiichi $4 billion upfront to co-develop and co-commercialize. Multiple clinical trials are ongoing across 15 types of cancer.
Source: https://www.fiercebiotech.com/biotech/daiichi-merck-pull-her3-dxd-filing-fda-after-confirmatory-trial-misses-survival-endpoint