Shots:
- The US FDA has granted priority review to sevabertinib (BAY 2927088; reversible TKI) for the treatment of previously treated pts with advanced NSCLC harboring HER2 mutations
- Designation was based on the P-I/II (SOHO-01) trial assessing (20mg, BID, PO) in HER2-mutant NSCLC, with data previously reported from 2 cohorts: pts progressing on ≥1 systemic therapy who were either HER2 therapy–naïve (Cohort D) or previously treated with ADCs (Cohort E)
- As of Oct 14, 2024, 44 pts in cohort D & 34 in cohort E were treated; ORR was 70.5% (D) & 35.3% (E), disease control rates were 81.8% (D) & 52.9% (E), with mDoR of 8.7mos. (D) & 9.5mos (E)
Ref: Bayer | Image: Bayer| Press Release
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