BAY 2927088 Achieves ~59% ORR in Advanced HER2-Mutant NSCLC

BAY 2927088 is a potent, orally available, HER2 (ERBB2) reversible tyrosine kinase inhibitor (TKI). In the SOHO-01 Phase I/II trial (NCT05099172), patients with advanced NSCLC with HER2-activating mutations received oral BAY 2927088 20 mg twice daily. Both pretreated (n=81) and first-line (n=39) cohorts showed similar investigator-assessed ORRs of 59.3% and 59.0%, diarrhea was the most frequent TRAE (84% and 82%) and led to dose reduction in 11% of one cohort, yet no treatment discontinuations or interstitial-lung disease cases were reported.

Compared to trastuzumab deruxtecan, the standard of care for HER2-mutant NSCLC DESTINY-Lung02 trial (NCT03505710), with an ORR of 49% and grade 3 or higher treatment-related adverse events in 39%.