Zongertinib (HERNEXEOS) — an oral HER2-selective tyrosine kinase inhibitor — in HER2 (ERBB2)-mutant advanced NSCLC. Boehringer Ingelheim. Guardant360 CDx companion diagnostic FDA-approved June 11, 2026.
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Update from ASCO 2026! Get expert insights on the latest data in 𝘏𝘌𝘙2-mutant non-small cell lung cancer (NSCLC) 📺 Dr @herbloong & Dr @ipreeshagul review data from SOHO-01, Beamion LUNG-3, PRO results from the Beamion LUNG-1 trial, & advances in HER2 testing Programme https://t.co/jCjavHJSJT
Presented at #AACR25: Among patients with tumors harboring tyrosine kinase domain mutations who received zongertinib (a selective inhibitor of the HER2 tyrosine kinase), 71% had a response, and median progression-free survival was 12.4 months. Full study results: https://t.co/QEsXsFxnkP
Zongertinib is now approved for Her2+ NSCLC based off Beamion Lung-1! We had a chance to 🗣️ Her2 testing, trial, findings, AEs and sequencing w/ @JSabari Full 🗣️: ⭐️ https://t.co/Y5WjnOlts8 ⭐️ Also on “Oncology Brothers” podcast #OncTwitter #lcsm @OncUpdates https://t.co/FWgOwiwZVc
Developments in HER2 exon 20 ins lung cancer: Boehringer & Bayer see ORRs of 60-70% with zongertinib & BAY2927088, but watch the tox! (Both molecules now in phase 3.) Via @ApexOnco from #WCLC24 -> https://t.co/tyDdvIdCGG https://t.co/b5hW7TeV7f
🎉🎉🎉We celebrate #FDA approval of #zongertinib as the first TKI in #HER2-mutant #NSCLC 🎊 🎂 🌺 🩷 👉 ORR 71% 👉 Duration of Response 14.1 months 👉 PFS 12.4 months 👉 Well-tolerated at 120mg dose 📖 In previously treated patients without prior anti-HER2 targeted therapies https://t.co/IS6XfykHSI
💊 It seems like we have two new “osimertinibs” for HER2 mutations. BAY 2927088 and Zongertinib hit the 70% response rate threshold with an acceptable toxicity profile. Already ph3 trials in 1st line HER2mut NSCLC ongoing. Competitive indication with Trastu-DXd. #WCLC24 #LCSM https://t.co/QXUErUWwig
🔥#WCLC24 Presidential 2 🎙️Dr. Gerrina Ruiter 🎯Primary Phase Ib Analysis of Beamion LUNG-1: Zongertinib (BI 1810631) in Patients with HER2 Mutation-Positive NSCLC #LCSM @IASLC @OncoAlert https://t.co/Q5L0yj5oBa https://t.co/zjS2IXAfre
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 & @NICEComms approvals to follow! @royalmarsdenNHS @ICR_London https://t.co/rL4vpUJOkW
🔥🚨@OncoAlert Hot Off The Press. Just published @NEJM Results of: ⭐️ #Beamion LUNG-1 phase 1a–1b of: #Zongertinib (#Oral, irreversible, HER2 #TKI) in previously treated #Patients with advanced #HER2-mutant non-small- cell #LungCancer (#NSCLC). 👇🏻 https://t.co/GAgn3eaebG https://t.co/T2Lgcb2TWm
Zongertinib in #HER2 NSCLC simultaneous publication @NEJM with #AACR25 presentation by Dr. John Heymach. In previously treated HER2 TKD mt NSCLC, RR 71%, duration of response 14.1m, mPFS 12.4m. G3 AEs in only 17% - diarrhea in 56% of pts but only 1 single case of G3 or higher. https://t.co/ZzSoeixFCy
Beamion LUNG-1 is the pivotal Phase 1b trial of zongertinib (HERNEXEOS), an oral, irreversible tyrosine kinase inhibitor that selectively targets HER2 (ERBB2) while sparing wild-type EGFR — a design intended to minimize EGFR-related toxicity. The trial enrolled patients with HER2 (ERBB2) tyrosine kinase domain-mutant advanced non-small cell lung cancer, a subset representing roughly 2–4% of NSCLC and historically associated with poor prognosis. Results supported zongertinib's FDA accelerated approval (August 2025), and on June 11, 2026 the FDA approved Guardant360 CDx as a blood-based companion diagnostic to identify eligible patients.
First-line (treatment-naïve) HER2-mutant NSCLC: confirmed ORR 76% (11% complete responses), median duration of response 15.2 months. Previously treated (cohort 1): confirmed ORR 71%. Among 30 patients with active brain metastases, the confirmed intracranial ORR was 47% (RANO-BM). Accelerated approval was based on ORR and duration of response.
First-line (treatment-naïve) cohort: median PFS 14.4 months (95% CI 11.1–NE). Previously treated cohort 1: median PFS 12.4 months (95% CI 8.2–NE). Treatment-related adverse events were predominantly low-grade (mainly diarrhea).
Guardant360 CDx (FDA-approved June 11, 2026) is a blood-based ctDNA assay that detects HER2 (ERBB2) tyrosine kinase domain activating mutations to identify patients eligible for zongertinib — offering a faster, less invasive alternative to tissue biopsy.
