Estela Rodriguez, Associate Director of Community Outreach-Thoracic Oncology at Sylvester Comprehensive Cancer Center, shared on X:
“2026 has already been an exciting year for precision medicine in lung cancer.
- Zongertinib: The first oral HER2-taargeted TKI for HER2-mutant NSCLC. (Beamion LUNG-1)
- Zidesamtinib: A next-generation selective ROS1 inhibitor for previously treated ROS1-positive NSCLC (ARROS-1)
Both agents demonstrate impressive CNS activity. Now the challenge is to improve access to NGS/biomaker testing and drugs.
1L Zongertinib (Beamion-LUNG1). Treatment naive HER2+ NSCLC (n=74):
- ORR: 76%, Median DoR: 15.2 months
- Median PFS: 14.4 months
- CNS Activity (exploratory n=30), Intracranial ORR: 47%
- Grade ≥3 TRAEs: 19%,
- Common AEs low grade: Diarrhea, Rash, LFT, Fatigue, Nausea.
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.
Zidesamtinib for ROS1+ NSCLC (previously treated) – ARROS-1, n=117
- ORR: 44% (49% after 1 prior ROS1 TKI; 38% after ≥2 prior ROS1 TKIs)- prior repotrectenib (n=46), taletrectenib (n=19)
- Durability: 82% had response ≥6 months; 69% remained in response ≥12 months
- CNS Activity: Intracranial ORR 48%, including 20% complete intracranial responses
- Activity in resistance mutations such as G2032R.
- Treatment discontinuation due to AEs: 2% Common AEs (mostly Grade 1–2): ALT/AST elevation, CPK elevation, dysgeusia, nausea, myalgia.”
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