Daiichi Sankyo and MSD have voluntarily withdrawn the biologics licence application (BLA) in the US for their HER3-directed DXd antibody drug conjugate (ADC) patritumab deruxtecan, intended for treating non-small cell lung cancer (NSCLC).
The withdrawal follows discussions with the US Food and Drug Administration (FDA) and topline outcomes from the Phase III trial, HERTHENA-Lung02, which did not meet overall survival (OS) statistical significance.
The withdrawal decision was made independently of a complete response letter for the therapy received from the agency in June 2024, relating to an inspection of a third-party manufacturing facility.
Discovered by Daiichi Sankyo, the therapy is being co-developed by both companies.
The parties have sought approval to treat adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC who have previously undergone two or more systemic treatments.
HERTHENA-Lung02 assesses the therapy as a single agent against doublet chemotherapy comprising platinum with pemetrexed induction chemotherapy, followed by pemetrexed maintenance chemotherapy.
The safety profile observed in the trial was found to be consistent with prior trials, with no safety concerns.
Daiichi Sankyo research and development global head Ken Takeshita said: “While we are disappointed with the OS 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.”
In October 2023, the companies signed a worldwide partnership to co-develop and commercialise the therapy, along with ifinatamab deruxtecan and raludotatug deruxtecan, with Daiichi Sankyo retaining exclusive rights in Japan.
The collaboration expanded in August 2024 to include gocatamig, which will be co-developed and commercialised globally, excluding Japan where MSD holds exclusive rights.
