Several oncologists recently shared the newly published NEJM study by John V. Heymach et al. on first-line zongertinib (Beamion LUNG-1 trial) in advanced HER2-mutant non-small cell lung cancer:
“Great to finally see this paper out, what a wonderful milestone! Zongertinib is changing the landscape for patients with HER2-mutant lung cancer.
In previously untreated pts, 76% ORR and a mPFS of 14.4 mo. Crucially, it showed a 47% intracranial response for those with active BM!”
“Another anti-HER2 treatment is entering the field, now for lung cancer. Our options in HER2-mutant NSCLC are clearly growing.
Key findings:
- ORR 76%
- Median PFS 14.4 months
- Median DoR 15.2 months
- Intracranial ORR 47%
The real question is now shifting: Which HER2-targeted drug is best for which patient? And how should we sequence these therapies in practice?”
“Delighted to see our data on 1st line zongertinib in HER2 TKD mutant NSCLC pts with and without CNS mets (BEAMION-Lung01), now in NEJM. Now FDA approved 1st line. Hoping for MHRAgovuk and NICE approvals to follow!”
“Hot Off The Press. Just published.
Results of First Line Cohort in Beamion LUNG-1 phase 1a/1b of: Zongertinib (Oral, irreversible, HER2 TKI) for: Patients with advanced HER2-mutant non-small- cell Lung Cancer (NSCLC) with no prior Treatment.
- RR: 76%
- mDOR: 15.2 months
- mPFS: 14.4 months
FDA approved in 1st line in Feb 2026.”
Title: First-Line Zongertinib in Advanced HER2-Mutant Non–Small-Cell Lung Cancer
Authors: John V. Heymach, Noboru Yamamoto, Nicolas Girard, Gerrina Ruiter, Egbert F. Smit, David Planchard, Ernest Nadal, Yi-Long Wu, Jon Zugazagoitia, Hai-Yan Tu, Christina S. Baik, Kiyotaka Yoh, Ross A. Soo, Yanqiu Zhao, Joshua K. Sabari, Martin Wermke, Matthias Scheffler, Myung-Ju Ahn, Kristie Fernamberg, Lukas Schroeter, Behbood Sadrolhefazi, Claus Thamer, Sabina Eigenbrod-Giese, Sanjay Popat
Read the Full Article.
Zongertinib Receives FDA Accelerated Approval in HER2-Mutant NSCLC
