Bayer has received regulatory approval in the US for sevabertinib as the first targeted therapy for HER2 tyrosine kinase domain (TKD)-mutant non squamous non-small cell lung cancer (nsq-NSCLC) following systemic treatment, based on the Phase I/II SOHO-01 trial showing 71% objective response rate (ORR) in treatment-naive patients and 38% response post antibody drug conjugate (ADC) therapy. The oral non-covalent reversible inhibitor targets HER2 and EGFR mutations including exon 20 insertion variants, with median duration of response (DOR) reaching 9.2 months in the pretreated population and 7.0 months in heavily pretreated patients, including those receiving prior HER2-directed therapy.

Sevabertinib's mechanism provides an alternative to ADC therapy through selective kinase inhibition, with reversible binding reducing off-target effects compared to covalent inhibitors. Bayer plans further development in earlier treatment lines and combination strategies with ADCs, leveraging complementary mechanisms targeting HER2-altered malignancies across lung and other solid tumours.

According to PharmCube's NextBiopharm® database, sevabertinib is under development in 10 more oncology indications. Click here to request a free trial for NextBiopharm®.