Daiichi Sankyo and Merck have withdrawn their biologics license application (BLA) for the accelerated approval of patritumab deruxtecan in the US.
The application was initially based on the HERTHENA-Lung01 Phase 2 trial, targeting adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously undergone at least two systemic therapies.
The decision follows a review of the overall survival results from the confirmatory HERTHENA-Lung02 Phase 3 trial, failed to deliver statistical significance, alongside discussions with the US Food and Drug Administration (FDA). This decision is not related to a Complete Response Letter received in June 2024 regarding a third-party manufacturing facility inspection, said the companies.
Merck Research Laboratories global clinical development head and chief medical officer Eliav Barr said: “Lung cancer is one of the leading causes of cancer-related deaths worldwide and these results are a reminder of how challenging it can be to treat these patients with EGFR-mutated non-small cell lung cancer in the second and later line settings.”
Developed by Daiichi Sankyo and Merck, patritumab deruxtecan is an investigational HER3-directed antibody-drug conjugate (ADC).
The results from the HERTHENA-Lung02 trial, which include significant progression-free survival data along with overall survival outcomes, are set for presentation at the American Society of Clinical Oncology’s Annual Meeting (#ASCO25) on 1 June 2025.
Daiichi Sankyo research and development global head Ken Takeshita said: “EGFR-mutated non-small cell lung cancer has proven to be difficult-to-treat in the second-line metastatic setting and beyond.
“While we are disappointed with the overall survival results of HERTHENA-Lung02, we are conducting further biomarker analyses to better identify patients that may benefit from patritumab deruxtecan to guide our continued development in lung cancer.
“We remain confident in the broad development programme of this HER3 directed antibody drug conjugate, which currently includes multiple clinical trials across 15 types of cancer.”
The HERTHENA-Lung02 trial is assessing patritumab deruxtecan compared to a combination of platinum and pemetrexed chemotherapy, followed by maintenance pemetrexed therapy. The patients involved in the trial are those with EGFR-mutated advanced NSCLC who have progressed following treatment with a third-generation EGFR tyrosine kinase inhibitor.
Patients showing tumour response will continue with their respective treatment until further disease progression as assessed by investigators.
The safety profile observed in HERTHENA-Lung02 aligns with previous trials involving patritumab deruxtecan, with no new safety concerns identified.
Patritumab deruxtecan employs Daiichi Sankyo’s proprietary DXd ADC Technology, featuring a monoclonal antibody linked to topoisomerase I inhibitor payloads via cleavable linkers.
In October 2023, Daiichi Sankyo and Merck entered a global partnership to co-develop and commercialise patritumab deruxtecan and other drug candidates except in Japan, where the former retains exclusive rights.
