# SOHO-01

Source: https://onco.cc/trials/soho-01/  
OnCo record `soho-01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

SOHO-01 is the study behind the second oral HER2 pill for lung cancer, approved in November 2025.

## Summary

SOHO-01, trial NCT05099172 sponsored by Bayer and reported in 2025, is the phase 1/2 study behind sevabertinib, the second oral HER2 inhibitor for lung cancer, which received accelerated approval on 20 November 2025. In previously treated HER2-mutant non-small-cell lung cancer the objective response rate was around 64 percent, higher in patients who had not received HER2-directed therapy, and the cohort treated after platinum chemotherapy responded in more than seventy percent of cases at the 20 mg dose; a first-line supplemental application received priority review in 2026. OnCo links it to HER2 as a target and to sevabertinib, and the result is consistent with zongertinib in Beamion LUNG-1 for oral HER2 inhibition. It is a single-arm study, and whether an oral HER2 inhibitor beats trastuzumab deruxtecan in this population is the open question. Sevabertinib has its own page.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT05099172
- Phase: 1/2
- Setting: HER2-mutant NSCLC, previously treated and treatment-naive: sevabertinib single arm
- Sponsor: Bayer
- Enrolled: 407
- Result: ORR ~64%; accelerated approval Nov 2025.
- Outcomes: Objective response rate, HER2-mutant NSCLC after platinum (Cohort D): Sevabertinib 20 mg 70.5%
- Replication: Single-arm pivotal; consistent with zongertinib (Beamion LUNG-1, ORR 71%) for oral HER2 inhibition.

## Sources

- ClinicalTrials.gov NCT05099172: https://clinicaltrials.gov/study/NCT05099172
- Bayer approval release: https://www.bayer.com/en/us/news-stories/hyrnuo

## Connected records

- cancers: [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Sevabertinib](https://onco.cc/drugs/sevabertinib/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- key papers: [Sevabertinib in Advanced HER2 -Mutant Non-Small-Cell Lung Cancer](https://onco.cc/key-papers/paper-soho-01-n-engl-j-med-2025/)

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