Bayer's new oral targeted therapy, sevabertinib, shows promising results in shrinking lung tumors with HER2 mutations, based on preliminary data from a Phase 1/2 trial.

The trial reported a response rate of 70.5% among patients who had prior HER2-targeted therapy, with a median progression-free survival of 8.3 months, highlighting significant clinical benefit.

Presented at ESMO 2025 and published in the New England Journal of Medicine, the SOHO-01 trial involved 209 patients across different treatment stages, demonstrating sevabertinib's effectiveness regardless of previous therapies.

Sevabertinib works by inhibiting tyrosine kinase enzymes, specifically targeting mutated HER2 and EGFR proteins, with potential applications in breast and gastroesophageal cancers.

The drug has shown efficacy in cell and animal studies, slowing tumor growth and shrinking tumors with HER2 exon 20 insertion mutations.

Patients treated with sevabertinib, including those previously exposed to HER2-targeted antibody-drug conjugates, experienced tumor reduction, with diarrhea being the most common side effect and no reports of interstitial lung disease.

This research underscores the importance of persistent, collaborative efforts in developing new treatments for hard-to-treat cancers, offering hope for improved outcomes.

The development of sevabertinib highlights the power of genetic insights from cancer patients and the critical role of ongoing collaboration between research institutes and industry.

The research builds on earlier work by the Broad Institute, which identified mutations in lung cancer patients resistant to existing treatments, leading to targeted drug development.

Sevabertinib has received FDA priority review and Breakthrough Therapy designation, supporting its application for accelerated approval, and aims to be a safer, more effective alternative to existing therapies like trastuzumab deruxtecan.

Currently under FDA Priority Review, sevabertinib could become the first FDA-approved cancer drug resulting from Broad discoveries and the Broad-Bayer research alliance.

In the SOHO-01 trial, over 70% of patients with HER2-mutant advanced non-small cell lung cancer experienced tumor shrinkage or disappearance, indicating strong anti-tumor activity.