Key Takeaways
•The U.S. Food and Drug Administration (FDA) has granted Priority Review to Boehringer Ingelheim’s new drug application for zongertinib (BI 1810631) as a treatment for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) mutations, who have received prior systemic therapy.
•The application is supported by positive results from the Phase Ib Beamion LUNG-1 trial, which demonstrated a 71% objective response rate in 75 previously treated patients with advanced NSCLC.
•If approved, zongertinib would become the first orally administered, targeted therapy for this patient population, addressing a significant unmet medical need.
Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has accepted its new drug application for zongertinib (BI 1810631) and granted it Priority Review status. This designation is reserved for therapies that offer significant improvements in the treatment of serious conditions, expediting the review process to approximately six months compared to the standard ten months. The Prescription Drug User Fee Act (PDUFA) action date is anticipated in the third quarter of 2025.
Zongertinib is an investigational, irreversible tyrosine kinase inhibitor (TKI) designed to selectively inhibit HER2 (ERBB2) while sparing EGFR, thereby potentially reducing associated toxicities. If approved, it would represent the first orally administered, targeted therapy specifically for patients with HER2-mutant advanced non-small cell lung cancer (NSCLC) who have undergone prior systemic therapy.
This development underscores the urgent need for effective treatments in this subset of lung cancer patients, who currently have limited therapeutic options and a poor prognosis. Shashank Deshpande, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, expressed optimism about zongertinib’s potential to transform care for these patients and highlighted the company’s commitment to continued research in other tumor types and lines of therapy.
Beamion LUNG-1 Trial Supports Efficacy
The FDA’s Priority Review decision is based on compelling data from the Phase Ib Beamion LUNG-1 trial. In Cohort 1 of this study, 75 previously treated patients with advanced NSCLC harboring HER2 tyrosine kinase domain mutations received zongertinib. The results demonstrated an objective response rate (ORR) of 71%, with six-month progression-free survival (PFS) and duration of response (DoR) rates of 69% and 73%, respectively.
These findings indicate that zongertinib elicits a robust and durable response in a patient population with historically limited treatment options. The safety profile of zongertinib was favorable, with a low incidence of dose reductions (5%) and treatment discontinuations (3%).
The majority of treatment-related adverse events (TRAEs) were mild, with diarrhea (51%) and rash (27%) being the most common. Importantly, no new safety signals were observed, and there were no reported cases of treatment-related interstitial lung disease (ILD). These safety and efficacy data suggest that zongertinib could offer a well-tolerated and effective therapeutic option for patients with HER2-mutant advanced NSCLC.
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