By Fineline Cube 
German pharmaceutical giant Bayer AG (ETR: BAYN) announced that its investigational oral small-molecule tyrosine kinase inhibitor (TKI), sevabertinib (BAY 2927088), has received priority review designation from the U.S. Food and Drug Administration (FDA) for the treatment of HER2-mutant advanced non-small cell lung cancer (NSCLC). If approved, sevabertinib could become the world’s first commercialized HER2-targeted small-molecule kinase inhibitor. The FDA and China’s National Medical Products Administration (NMPA) had previously granted Breakthrough Therapy Designations to sevabertinib in 2024.
Clinical Trial Results
The regulatory filing is based on positive results from the ongoing Phase I/II SOHO-01 trial. In patients with HER2-mutant NSCLC who had not previously received HER2-targeted therapy, sevabertinib demonstrated an objective response rate (ORR) of 70.5% and a median response duration of 8.7 months. Among patients who had received prior HER2-targeted antibody drug conjugate therapy, the ORR was 35.3%, with a median duration of response of 9.5 months. The safety profile of sevabertinib was found to be manageable and consistent with previous reports.
Future Development
Sevabertinib is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring HER2 activating mutations. The drug is also under investigation in patients with metastatic or unresectable solid tumors with HER2-activating mutations, excluding advanced non-small cell lung cancer (NSCLC).-Fineline Info & Tech