Patritumab Deruxtecan biologics license application (BLA) for patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer voluntarily withdrawn

CAR-T Digest - August 2020

Weekly Digest - May 2025

29 May 2025: Patritumab Deruxtecan biologics license application (BLA) for patients with previously treated locally advanced or metastatic EGFR–mutated non-small cell lung cancer voluntarily withdrawn

Daiichi Sankyo and Merck voluntarily withdrew their BLA for Patritumab deruxtecan in previously treated EGFR-mutated NSCLC due to overall survival (OS) results from the HERTHENA-Lung02 Phase 3 trial not meeting statistical significance
Patritumab deruxtecan, a HER3-directed antibody-drug conjugate, showed statistically significant progression-free survival (PFS) in the Phase 3 HERTHENA-Lung02 trial, but not OS
Detailed results from the HERTHENA-Lung02 trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting on June 1
The decision was unrelated to the complete response letter received in June 2024, which addressed issues from a third-party manufacturing facility inspection
Despite the BLA withdrawal, the drug’s development continues, with ongoing biomarker analysis and trials in 15 cancer types, as both companies reaffirm their commitment to advancing HER3-targeted therapy