On 17 September 2024, Daiichi Sankyo and MSD announced positive results from a Phase 3 trial of their antibody drug conjugate, patritumab deruxtecan (HER3-DXd). In the trial (HERTENA-Lung02), patritumab deruxtecan showed statistically significant improvement in progression-free survival of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment. Daiichi Sankyo and MSD intend to present data from the trial to global regulatory authorities.
In December 2023, the FDA accepted for priority review Daiichi Sankyo’s and MSD’s Biologics Licence Application (BLA) for patritumab deruxtecan to treat adult patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with two or more systemic therapies. However, in June 2024, the FDA issued a Complete Response Letter (CRL) in respect of the BLA, resulting from an inspection of a third-party manufacturing facility.
Patritumab deruxtecan is the subject of a global development and commercialisation collaboration between Daiichi and MSD (announced in October 2023), which also involves ifinatamab deruxtecan and raludotatug deruxtecan.