August 08, 2025
1 min read
Key takeaways:
- The FDA approved Hernexeos for adults with unresectable or metastatic non-small cell lung cancer.
- It received accelerated approval based on a 75% objective response rate in a Phase 1b trial.
The FDA approved Hernexeos (zongertinib tablets, Boehringer Engelheim) for the treatment of adults with unresectable or metastatic NSCLC, Boehringer Ingelheim announced in a press release.
Specifically, Hernexeos is indicated for patients whose tumors carry HER2 (ERBB2) tyrosine kinase domain activating mutations and who have previously received systemic treatment.
The FDA approved Hernexeos (zongertinib tablets, Boehringer Engelheim) for the treatment of adults with unresectable or metastatic NSCLC.
The FDA granted this indication under accelerated approval, based on data from the Phase 1b Beamion-LUNG 1 trial, in which it showed an objective response rate of 75% (n=71%), with 6% of patients achieving a complete response and 69% of patients showing a partial response. A duration of response lasting 6 months or longer was seen in 58% (n=53).
Positive results from Beamion-LUNG 1 were presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 and published in The New England Journal of Medicine.
Zongertinib showed a manageable safety profile, with a 2.9% discontinuation rate. In a combined safety population, diarrhea (53%), hepatotoxicity (27%), rash (27%) fatigue (22%) and nausea (21%) were the most common (>20%) adverse reactions.
“We are grateful to be able to bring HERNEXEOS, which has the potential to reset the benchmark for those living with HER2-mutant advanced non-small cell lung cancer, a condition associated with particularly poor prognosis,” Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim said in the release.
“Believing in the power of scientific innovation, we aim to provide meaningful improvements to this patient population. Recognizing its potential, we accelerated development to deliver this new treatment option to patients within four years of starting the first clinical trial.”
Sources/Disclosures
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Boehringer Ingelheim. Boehringer’s HERNEXEOS as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC. Available at: Boehringer’s HERNEXEOS® as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC. Published August 8, 2025. Accessed Aug. 8, 2025.
