New results from the Investigational agent BAY 2927088 in HER2-mutant non-small cell lung cancer (NSCLC) presented at WCLC

Data were presented during the Presidential Symposium at the IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer, taking place in San Diego, United States, from September 7-10, 2024. “The encouraging results from the expansion phase of the SOHO-01 trial demonstrate the potential of this targeted therapy to advance outcomes for patients with HER2-mutant NSCLC, a type of lung cancer with limited treatment options and poor prognosis,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “The development of BAY 2927088 underscores our ongoing commitment in lung cancer and our continued drive to develop precise and personalized healthcare solutions in disease areas with the highest unmet needs.”

“HER2-mutant NSCLC is a challenging disease that can predominantly affect individuals who are young and never smoked a cigarette. Given the current lack of therapeutic options, there is an immediate need for effective, manageable treatments,” said SOHO-01 lead trialist, Xiuning Le, MD, PhD, The University of Texas MD Anderson Cancer Center, Houston, TX. “BAY 2927088 showed promising preliminary efficacy in both response rate and duration, and a manageable safety profile, which emphasizes the importance of ongoing innovation to elevate the standard of care.”

The objective of the expansion phase of the study was to determine the safety, tolerability, and pharmacokinetics of BAY 2927088 in patients with HER2-mutant NSCLC. These data support the ongoing investigation of BAY 2927088 in patients with advanced NSCLC harboring HER2 mutations. Just recently Bayer announced that the first patient has been enrolled in the global Phase III SOHO-02 trial, an open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer, whose tumors have activating HER2 mutations.

Detailed Results from SOHO-01; SOHO-01 is an ongoing, open-label, multicenter Phase I/II study. Results from patients with advanced NSCLC harboring a HER2-activating mutation with disease progression after ?1 systemic therapies for advanced disease, and who are naïve to HER2-targeted therapy were presented. In the trial, patients received oral BAY 2927088 20 mg twice daily.Forty-three out of forty-four patients enrolled were evaluable for efficacy, with a confirmed objective response rate (ORR) of 72.1% (n=31; 95% CI 56.3, 84.7) including 1 complete response (2.3%). Median duration of response (DOR) and progression-free survival (PFS) were 8.7 months (95% CI 4.5, not estimable) and 7.5 months (95% CI 4.4, 12.2), respectively. In patients with HER2 YVMA insertions, the most frequent mutation, ORR was 90.0%, DoR was 9.7 months, and PFS was 9.9 months.

The safety profile of BAY 2927088 was found to be manageable, and consistent with previous reports. Treatment-related adverse events (TRAEs) were reported in 95.5% of patients, with grade 3 TRAEs reported in 40.9%. Diarrhea was the most common TRAE (86.4%, 25.0% grade 3), followed by rash (43.2% grade 1 or 2) and paronychia (25.0% grade 1 or 2). Three patients (6.8%) discontinued due to TRAEs.