marked.bio

HER2 TKI · small molecule

sevabertinib

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

Also known as BAY 2927088, Hyrnuo.

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
sevabertinib
FDA, 2025
locally advanced or metastatic non-squamous, HER2 TKD activating mutation, after prior systemic therapy FDA accelerated approval 19/11/2025; companion test Oncomine Dx Target Test. Source
FDA, 2026
first line, locally advanced or metastatic non-squamous, HER2 TKD activating mutation FDA accelerated approval 09/09/2026 (expands the indication to untreated patients). Source
Hyrnuo 		HER2 (ERBB2) activating mutation NSCLC Approved 2025 accelerated Not approved

SOHO-01 single-arm, 70 no prior HER2 drug; 52 after a HER2 ADC
Response 71% (no prior HER2 drug); 38% (after a HER2 ADC) (59-82; 25-53)Lasting 9.2 months (no prior HER2 drug); 7.0 months (after a HER2 ADC)

Serious side effects 33%Stopped for side effects 4.2%Fatal 0.5%

Trial details and side effects
Patients
HER2 TKD-mutant non-squamous NSCLC after systemic therapy (NCT05099172)
Most common side effects
diarrhoea 90%, rash 76%, stomatitis 37%, paronychia 36%, nausea 22% (191 patients)
Notes
FDA approval summary (2025). Warnings include diarrhoea, liver toxicity and interstitial lung disease. Side effects: Hyrnuo US label, section 6 (HER2-mutant NSCLC).
Source
FDA approval summary

Biomarkers

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

Sponsors

Industry sponsors leading active biomarker-selected trials of sevabertinib.

  1. Bayer 3

Trials

3 of 3 trials shown

  1. A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

    Recruiting Phase 3 Bayer Started 2024Primary completion 2027-10 NCT06452277

    sevabertinib FDApembrolizumabcisplatincarboplatinpemetrexed

    Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified…

    HER2 (ERBB2) activating mutationAdvanced Non-small Cell Lung Cancer, HER2 Mutation

  2. A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

    Recruiting Phase 2 Bayer Started 2025Primary completion 2029-02 NCT06760819

    sevabertinib FDA

    Documented activating HER2 mutation

    HER2 (ERBB2) activating mutationAdvanced Solid Tumors, HER2 Mutation

  3. First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

    Recruiting Phase 1/2 Bayer Started 2021Primary completion 2028-12 NCT05099172

    sevabertinib FDA

    Documented activating EGFR and/or HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States …

    HER2 (ERBB2) activating mutationAdvanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation