SOHO-01
SOHO-01 is the study behind the second oral HER2 pill for lung cancer, approved in November 2025.
ORR ~64% in previously treated HER2-mutant NSCLC (higher in HER2-directed-therapy-naive patients); accelerated approval 20 November 2025. A first-line supplemental application received priority review in 2026.
- 70.5 out of 100 people had their tumour shrink with Sevabertinib 20 mg.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: HER2-mutant NSCLC, previously treated and treatment-naive: sevabertinib single arm. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
407 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate, HER2-mutant NSCLC after platinum (Cohort D)primary | Sevabertinib 20 mg | — | 70.5% | — | — | link |
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not linked directly; found by shared links- ProductZongertinib
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