By Fineline Cube 
German pharmaceutical giant Boehringer Ingelheim (BI) announced that its HERNEXEOS (zongertinib tablets) has received accelerated approval from the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
Drug Mechanism
Zongertinib is an orally-administered tyrosine kinase inhibitor (TKI) that selectively targets HER2 (ERBB2). This approval provides a new therapeutic option for patients with this specific genetic mutation in NSCLC.
Clinical Trial Results
The accelerated approval is based on data from the Phase Ib Beamion-LUNG 1 trial. The trial demonstrated an objective response rate (ORR) of 75% (N=71), with 6% of patients achieving a complete response and 69% achieving a partial response. Notably, 58% of patients (n=53) maintained a duration of response of at least six months. Zongertinib also exhibited a manageable safety profile with a discontinuation rate of only 2.9%.-Fineline Info & Tech