marked.bio

HER2 TKI · small molecule

zongertinib

6 active trials, targeting HER2. 2 active approvals for a biomarker on marked.bio.

Also known as BI 1810631, Hernexeos.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
zongertinib
FDA, 2025
unresectable or metastatic non-squamous, HER2 TKD activating mutation, after prior systemic therapy FDA accelerated approval 08/08/2025; companion test Oncomine Dx Target Test. Source
FDA, 2026
first line, unresectable or metastatic non-squamous, HER2 TKD activating mutation FDA accelerated approval 26/02/2026 (expands the indication to untreated patients). Source
Hernexeos 		HER2 (ERBB2) activating mutation NSCLC Approved 2025 accelerated Not approved

Beamion LUNG-1 single-arm, 71 after platinum; 34 after platinum and a HER2 ADC
Response 75% (no prior HER2 drug); 44% (after a HER2 ADC) (63-83; 29-61)Lasting 58% and 27% of responses lasted 6 months or more

Serious side effects 36%Stopped for side effects 6%Fatal 0.6%

Trial details and side effects
Patients
HER2 TKD-mutant non-squamous NSCLC after systemic therapy (NCT04886804)
Most common side effects
diarrhoea 54%, rash 28%, liver toxicity 27%, fatigue 25%, nausea 23%, musculoskeletal pain 21%, upper respiratory infection 20% (177 patients)
Notes
FDA approval summary (2025). Boxed areas of warning: liver toxicity, heart function, interstitial lung disease. Side effects: Hernexeos US label, section 6 (Beamion LUNG-1; common side effects from 292 pooled patients).
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
HER2 (ERBB2) activating mutation 6 6 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of zongertinib.

  1. Boehringer Ingelheim 5

Trials

6 of 6 trials shown

  1. Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

    Recruiting Phase 3 Boehringer Ingelheim Started 2026Primary completion 2032-02 NCT07195695

    zongertinib FDApembrolizumabatezolizumabdurvalumabnivolumab

    HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor recepto…

    HER2 (ERBB2) activating mutationNon-small Cell Lung Cancer

  2. Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

    Active, not recruiting Phase 3 Boehringer Ingelheim Started 2024Primary completion 2026-12 NCT06151574

    zongertinib FDApembrolizumabcisplatincarboplatinpemetrexed

    Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.

    HER2 (ERBB2) activating mutationLung Cancer, Non-squamous, Non-small Cell

  3. A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.

    Not yet recruiting Phase 2 MedSIR Started 2026Primary completion 2028-09 NCT07619066

    zongertinib FDAfulvestrant

    Known activating HER2 mutation.

    HER2 (ERBB2) activating mutationAdvanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation

  4. Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab

    Recruiting Phase 2 Boehringer Ingelheim Started 2026Primary completion 2027-08 NCT07486817

    zongertinib FDAcisplatincarboplatinpemetrexedpembrolizumab

    Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result

    HER2 (ERBB2) activating mutationLung Cancer, Non-squamous, Non-small Cell

  5. Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

    Recruiting Phase 2 Boehringer Ingelheim Started 2024Primary completion 2028-11 NCT06581432

    zongertinib FDA

    …ented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)

    HER2 (ERBB2) activating mutationSolid Tumours

  6. Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

    Active, not recruiting Phase 1 Boehringer Ingelheim Started 2021Primary completion 2026-12 NCT04886804

    zongertinib FDA

    …ll lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain (TKD) as per local lab results.

    HER2 (ERBB2) activating mutationNeoplasm Metastasis, Non-Small Cell Lung Cancer