Bayer has reported promising results from the Phase I/II SOHO-01 study, which is evaluating BAY 2927088 for advanced HER2-mutant non-small cell lung cancer (NSCLC). The data were presented at the IASLC 2024 World Conference on Lung Cancer (WCLC) in San Diego.
“The results highlight the potential of BAY 2927088 to improve outcomes for patients with HER2-mutant NSCLC, a challenging cancer with limited treatment options,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer. “Our commitment to advancing lung cancer treatments continues with this promising development.”
Lead trialist Xiuning Le, MD, PhD, from MD Anderson Cancer Center, noted the urgent need for effective treatments for HER2-mutant NSCLC, which often affects younger, non-smoking individuals. “BAY 2927088 showed encouraging preliminary efficacy and a manageable safety profile,” Le added.
The expansion phase of SOHO-01 focused on the safety, tolerability, and pharmacokinetics of BAY 2927088. Results showed a 72.1% objective response rate (ORR) with a median duration of response (DoR) of 8.7 months and progression-free survival (PFS) of 7.5 months. For patients with HER2 YVMA insertions, ORR was 90.0%, with a DoR of 9.7 months and PFS of 9.9 months.
BAY 2927088’s safety profile was manageable, with treatment-related adverse events (TRAEs) in 95.5% of patients, and grade 3 TRAEs in 40.9%. Common TRAEs included diarrhea (86.4%), rash (43.2%), and paronychia (25.0%). Three patients (6.8%) discontinued treatment due to TRAEs.
Bayer has also started enrolling patients in the global Phase III SOHO-02 trial to further investigate BAY 2927088’s efficacy and safety in advanced NSCLC with HER2 mutations.
