- Daiichi Sankyo and Merck withdraw Biologics License Application for patritumab deruxtecan for EGFR-mutated NSCLC treatment.
- Decision follows HERTHENA-Lung02 phase 3 trial results where overall survival did not meet statistical significance.
- Further biomarker analysis will be conducted to identify potential patient benefits from patritumab deruxtecan.
The Biologics License Application (BLA) for patritumab deruxtecan, a HER3-directed antibody drug conjugate developed by Daiichi Sankyo (4568) and Merck (MRK, Financial), has been voluntarily withdrawn. This application aimed for accelerated approval in the U.S. for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), who have undergone two or more systemic therapies.
The withdrawal follows discussions with the U.S. Food and Drug Administration and is based on the HERTHENA-Lung02 phase 3 trial results, where overall survival did not meet statistical significance. This decision is independent of a Complete Response Letter received in June 2024 regarding third-party manufacturing facility inspections.
Patritumab deruxtecan, representing an investigational HER3-directed therapy, demonstrated statistically significant progression-free survival in earlier trials. However, further biomarker analyses are being conducted to identify specific patient groups who might benefit, guiding continued development in lung cancer treatment.
Results and detailed analyses from the HERTHENA-Lung02 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting. Despite the setback, Daiichi Sankyo and Merck emphasize their commitment to advancing the treatment landscape for challenging cancer types, including ongoing clinical trials across 15 types of cancer.
