- FDA approved HERNEXEOS based on a 76% response rate in the Beamion LUNG-1 trial.
- Approval is contingent on further clinical benefit verification in a Phase III trial.
- Boehringer is enrolling patients in the Beamion LUNG-2 confirmatory trial.
- Zongertinib showed a response duration of ≥6 months in 64% of patients.
FDA Approval
The U.S. Food and Drug Administration (FDA) has approved HERNEXEOS (zongertinib tablets) for treating adults with advanced non-small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain activating mutations. This approval is based on an objective response rate of 76% observed in the Beamion LUNG-1 clinical trial.
Accelerated Approval
The approval is granted under the FDA's accelerated approval pathway, contingent on further verification of clinical benefits in a confirmatory trial. Boehringer Ingelheim is currently enrolling patients in the Beamion LUNG-2 Phase III trial to confirm these results.
Clinical Trial Data
In the Phase Ib Beamion LUNG-1 trial, involving 72 treatment-naïve patients, HERNEXEOS demonstrated a 76% objective response rate, with 11% achieving complete response and 65% partial response. Additionally, 64% of patients experienced a response duration of six months or more.
