SOHO-01

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.