Sevabertinib (BAY 2927088) Receives FDA Priority Review for HER2-Mutant Non-Small Cell Lung Cancer
Thursday, May 29, 2025
Bayer’s investigational therapy sevabertinib (BAY 2927088) has been granted Priority Review by the US Food and Drug Administration (FDA) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) featuring activating HER2/ERBB2 mutations. This applies to patients who have already received prior systemic treatment.
Sevabertinib is an orally administered small molecule tyrosine kinase inhibitor (TKI). The application for Priority Review is based on encouraging data from the ongoing Phase I/II SOHO-01 study, which includes individuals with advanced NSCLC and HER2-activating mutations who had previously undergone at least one line of systemic therapy and had not received prior treatment with HER2-targeted TKIs.
The FDA’s Priority Review designation highlights the urgent medical need in this patient group and acknowledges the potential of sevabertinib to offer a meaningful clinical benefit. This designation aims to accelerate the review process for medicines that could significantly improve outcomes in serious conditions with limited treatment options.
The SOHO-01 study is being conducted as an open-label, multicentre Phase I/II trial. Latest results are available from two expansion cohorts: Cohort D includes patients who had not received HER2-targeted therapy, while Cohort E includes those previously treated with HER2-targeted antibody-drug conjugates. Both groups were administered 20 mg of sevabertinib twice daily.
As of 14 October 2024, 44 patients were treated in Cohort D and 34 in Cohort E. The objective response rate assessed by investigators was 70.5% in Cohort D and 35.3% in Cohort E. Disease control, defined as tumour response or stable disease lasting at least 12 weeks, was achieved in 81.8% of patients in Cohort D and 52.9% in Cohort E. Median duration of response was 8.7 months in Cohort D and 9.5 months in Cohort E.
The safety profile of sevabertinib remained manageable and aligned with earlier findings. Treatment-related adverse events were reported in 97.4% of participants, with diarrhoea being the most frequent cause of dose adjustment. However, no patients discontinued therapy due to diarrhoea, and no instances of interstitial lung disease were observed.
The development of sevabertinib continues as part of Bayer’s ongoing commitment to addressing unmet needs in oncology.
Source: bayer.com
