The US Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for zongertinib (BI 1810631), a treatment for adults with advanced non-small cell lung cancer (NSCLC) characterized by HER2 (ERBB2) mutations who have undergone prior systemic therapy. This designation accelerates the review process to six months instead of the standard ten, with a Prescription Drug User Fee Act (PDUFA) action date anticipated in the third quarter of 2025. If approved, zongertinib would be the first orally administered, targeted therapy for patients with previously treated HER2-mutated advanced NSCLC.
In 2023, zongertinib received FDA Fast Track and Breakthrough Therapy Designations, alongside a similar Breakthrough Therapy status from China’s Center for Drug Evaluation (CDE). Japan’s Pharmaceuticals and Medical Devices Agency has also classified it as an Orphan Drug.
The NDA submission is based on findings from the Phase Ib Beamion LUNG-1 trial. Data from Cohort 1 (N=75), 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, in patients with HER2 tyrosine kinase domain mutations.
Zongertinib’s safety assessment indicated a low occurrence of dose reductions (5%) and treatment discontinuations (3%). The most frequently reported treatment-related adverse events (TRAEs) were mild to moderate diarrhea (51%) and rash (27%). One patient experienced a Grade 3 or higher TRAE, and no treatment-related interstitial lung disease (ILD) was reported.
Beamion LUNG-1 (NCT04886804) is a phase I study assessing zongertinib as a standalone therapy in individuals with advanced solid tumors with HER2 alterations. The ongoing phase III Beamion LUNG-2 trial (NCT06151574) is enrolling patients with HER2-mutant NSCLC to compare zongertinib with standard treatments.
References
- Zongertinib receives priority review from FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer – Boehringer Ingelheim. Available at: https://www.pharmawand.co.uk/members/news.aspx?entityID=26800&alrtPrfID=1589 (date last accessed: 25 February 2025)
- Zongertinib Demonstrates Promising Efficacy in Patients with HER2-Mutant NSCLC: Primary Phase Ib Analysis of Beamion LUNG-1. Available at: https://www.iaslc.org/iaslc-news/press-release/zongertinib-demonstrates-promising-efficacy-patients-her2-mutant-nsclc (Date last accessed: 25 February 2025)
Disclosures: This article was created by the touchONCOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
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