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Bending the Curve Trial by Trial
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SOHO-01

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)

Phase 1/2N = 209NCT05099172

Population
Locally advanced or metastatic HER2-mutant NSCLC (209 patients received sevabertinib across cohorts D, E and F as of 27 June 2025)
Design
Open-label, multicentre, multicohort phase 1-2 study of sevabertinib 20 mg orally twice daily in locally advanced or metastatic HER2-mutant NSCLC; cohorts defined by prior therapy. Primary endpoint objective response by blinded independent central review.
Primary endpoint
ORR
Arms
  • Sevabertinib (experimental, n = 209): Sevabertinib 20 mg orally twice daily
People
Le X
Show the numbers
Results reported for SOHO-01
EndpointAnalysisSevabertinibControlEffect
ORRCohort D: previously treated, no HER2-targeted therapy (n=81)Objective response by blinded independent central reviewprimarymedian follow-up 13.8 monthsLe 202564% (53–75%)——
DORCohort D (n=81)primarymedian follow-up 13.8 monthsLe 2025median 9.2 months (6.3–13.5)——
PFSCohort D (n=81)primarymedian follow-up 13.8 monthsLe 2025median 8.3 months (6.9–12.3)——
ORRCohort F: previously untreated (n=73)Objective response by blinded independent central reviewprimarymedian follow-up 9.9 monthsLe 202571% (59–81%)—Median duration of response 11.0 months; progression-free survival data were immature. Grade 3 or higher drug-related adverse events occurred in 31% of the 209 patients overall; diarrhoea was the most common event. Cohort F included 73 previously untreated patients.
Results reported for SOHO-01
EndpointAnalysisSevabertinibControlEffect
ORRCohort D: previously treated, no HER2-targeted therapy (n=81)Objective response by blinded independent central reviewprimarymedian follow-up 13.8 monthsLe 202564% (53–75%)——
DORCohort D (n=81)primarymedian follow-up 13.8 monthsLe 2025median 9.2 months (6.3–13.5)——
PFSCohort D (n=81)primarymedian follow-up 13.8 monthsLe 2025median 8.3 months (6.9–12.3)——
ORRCohort F: previously untreated (n=73)Objective response by blinded independent central reviewprimarymedian follow-up 9.9 monthsLe 202571% (59–81%)—Median duration of response 11.0 months; progression-free survival data were immature. Grade 3 or higher drug-related adverse events occurred in 31% of the 209 patients overall; diarrhoea was the most common event. Cohort F included 73 previously untreated patients.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%05101520Months (modelled)
  • Sevabertinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSevabertinib
0100.0%
663.6%
1240.5%
1727.8%
2317.7%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Sevabertinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSevabertinib
0100.0%
565.9%
1043.4%
1626.3%
2117.3%
Primary publication: Le X, Kim TM, Loong HH, Prelaj A, Goh BC, Li L, et al. Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025;393(18):1819-1832. PubMedDOI

Appears in

Sources

  1. Le X, Kim TM, Loong HH, Prelaj A, Goh BC, Li L, et al. Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025;393(18):1819-1832.

    PubMedDOI