Pharma Focus Asia

Bayer Introduces Breakthrough Therapy BAY 2927088 for Non-Small Cell Lung Cancer

Bayer has introduced a groundbreaking therapy named BAY 2927088 for addressing adult patients afflicted with unresectable or metastatic non-small cell lung cancer (NSCLC), particularly those whose tumours exhibit activating HER2 (ERBB2) mutations and who have previously undergone systemic therapy.

BAY 2927088 is an orally administered, reversible tyrosine kinase inhibitor (TKI) designed to effectively target mutant forms of human epidermal growth factor receptor 2 (HER2), encompassing HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR). It demonstrates significant selectivity for mutant EGFR compared to the wild-type variant.

Lung cancer stands as the primary cause of cancer-related fatalities globally, with NSCLC constituting over 85 percent of cases. Activating HER2 mutations are detected in approximately 2 to 4 percent of advanced NSCLC cases. 

Currently, no therapies have secured full approval in the United States for patients with NSCLC in the metastatic or advanced stages harbouring HER2 activating mutations.

The designation of breakthrough therapy is demonstrated by initial clinical data derived from a Phase I, open-label, multicenter trial (NCT05099172) investigating the safety, pharmacokinetics, and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC displaying HER2 or EGFR mutations.

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