Bayer has announced encouraging results from the expansion phase of the SOHO-01 study, evaluating BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC). The oral tyrosine kinase inhibitor (TKI) demonstrated promising efficacy and a manageable safety profile, warranting further investigation as a potential treatment option for this patient population.
BAY 2927088 is designed to selectively inhibit mutant human epidermal growth factor receptor 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR) with high selectivity for mutant versus wild-type EGFR.
SOHO-01 Study Results
The expansion phase of the SOHO-01 study aimed to assess the safety, tolerability, and pharmacokinetics of BAY 2927088 in patients with HER2-mutant NSCLC. Patients received oral BAY 2927088 at a dose of 20 mg twice daily. Of the 45 patients enrolled, 43 were evaluable for efficacy.
The study reported a confirmed objective response rate (ORR) of 72.1%, including one complete response. The median duration of response (DoR) was 8.7 months, and the median progression-free survival (PFS) was 7.5 months. Notably, patients with HER2 YVMA insertions, the most frequent mutation in the study, exhibited an ORR of 90%, a DoR of 9.7 months, and a PFS of 9.9 months.
Treatment-related adverse events (TRAEs) were observed in 95.5% of patients, with grade 3 TRAEs reported in 40.9%. The safety profile was considered manageable and consistent with previous reports.
Ongoing and Future Development
These findings support the continued development of BAY 2927088 for patients with advanced NSCLC harboring HER2 mutations. Bayer has recently initiated the Phase III SOHO-02 study to evaluate the efficacy and safety of BAY 2927088 as a first-line therapy in patients with advanced non-small cell lung cancer whose tumors have activating HER2 mutations.
Context of HER2-Mutant NSCLC
NSCLC accounts for a significant proportion of lung cancer cases globally, and HER2 mutations are present in a subset of these patients. Effective targeted therapies are needed to improve outcomes for this population. The development of BAY 2927088 represents a potential advancement in the treatment landscape for HER2-mutant NSCLC.
