{"entity":{"id":"soho-01","kind":"trial","name":"SOHO-01","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05099172","url":"https://clinicaltrials.gov/study/NCT05099172"},{"label":"Bayer approval release","url":"https://www.bayer.com/en/us/news-stories/hyrnuo"}],"tags":[],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["her2"],"drugs":["sevabertinib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-soho-01-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05099172","phase":"1/2","setting":"HER2-mutant NSCLC, previously treated and treatment-naive: sevabertinib single arm","sponsor":"Bayer","participation":[{"nct":"NCT05099172","source":"https://clinicaltrials.gov/study/NCT05099172","fetchedAt":"2026-10-07T16:53:34.066Z","studySha256":"af1540d100a9b79c146167f734636f64a246a83c5690ab0204fa9a09f4c30e7d","overallStatus":"RECRUITING","lastUpdatePosted":"2026-08-12","leadSponsor":"Bayer","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":400,"enrolmentType":"ESTIMATED","siteCount":92,"recruitingSiteCount":3,"countries":["Belgium","Brazil","China","France","Hong Kong","Israel","Italy","Japan","Netherlands","Poland","Portugal","Singapore","South Korea","Spain","Taiwan","United States"]}],"result":"ORR ~64%; accelerated approval Nov 2025.","started":"2021-10-25","startedType":"actual","yearReported":2025,"enrolled":407,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate, HER2-mutant NSCLC after platinum (Cohort D)","primary":true,"unit":"%","arms":[{"name":"Sevabertinib 20 mg","value":70.5}],"source":"https://clinicaltrials.gov/study/NCT05099172"}],"replication":"Single-arm pivotal; consistent with zongertinib (Beamion LUNG-1, ORR 71%) for oral HER2 inhibition."},"route":"/trials/soho-01/","neighbours":{"cancer":[{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"sevabertinib","kind":"drug","name":"Sevabertinib","route":"/drugs/sevabertinib/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"paper":[{"id":"paper-soho-01-n-engl-j-med-2025","kind":"paper","name":"Sevabertinib in Advanced HER2 -Mutant Non-Small-Cell Lung Cancer","route":"/key-papers/paper-soho-01-n-engl-j-med-2025/"}]}}