Meet Zongertinib (Hernexeos) – a breakthrough drug for patients with HER2‑mutant lung cancer
Zongertinib (brand name: Hernexeos) is an innovative oral medication that acts as a selective HER2 receptor inhibitor and is intended for patients with non‑squamous NSCLC lung cancer who carry a HER2 mutation in the TKD domain.
The drug was approved by the FDA in August 2025 via an accelerated process, for patients who have already undergone at least one systemic treatment for their disease.
🔬 What did the studies show?
In the BEAMION LUNG‑1 phase 1a/1b study – an overall response rate (ORR) of approximately 71%–75%.
Durable response (DOR) was seen among patients who had not received prior ADC treatment.
Even among patients previously treated with HER2‑targeted ADC drugs – a response was observed (ORR of approx. 44%).
💊 Safety profile
Most side effects were mild (grade 1–2).
Most common: diarrhea (51%), rash (27%).
No cases of interstitial lung disease (ILD) were reported – a known issue with ADC‑type therapies.
Why is it important?
This is an effective, convenient, and safe treatment that offers new hope to patients with HER2‑mutant lung cancer. The drug is taken orally – unlike intravenous therapies – and provides a significant response with a chance to improve both life expectancy and quality of life.
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Read more (FDA & BI official sources):
FDA grants accelerated approval to zongertinib for non‑squamous NSCLC with HER2 TKD activating mutations – official FDA announcement from August 2025 on the accelerated approval of Zongertinib (Hernexeos) for HER2‑mutant NSCLC lung cancer.
U.S. Food and Drug Administration
https://www.boehringer-ingelheim.com/us/media/press-releases/hernexeos-zongertinib-tablets-gains-accelerated-approval
