New findings on BAY 2927088 in HER2-mutant NSCLC presented at WCLC

Bayer has announced promising outcomes from the expansion phase of its ongoing Phase I/II SOHO-01 study, which evaluates the safety and preliminary efficacy of BAY 2927088 in advanced HER2-mutant non-small cell lung cancer (NSCLC). These findings were presented at the IASLC 2024 World Conference on Lung Cancer in San Diego, USA.

Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division, expressed optimism regarding the trial’s results, emphasizing the potential of BAY 2927088 as a targeted therapy for patients with HER2-mutant NSCLC. This type of lung cancer has limited treatment options and a poor prognosis. Rommel highlighted Bayer’s commitment to developing personalized healthcare solutions for diseases with high unmet needs.

HER2-mutant NSCLC is a particularly challenging form of lung cancer that often affects younger individuals who have never smoked. Given the lack of effective treatments, there is an urgent need for new therapeutic options. Xiuning Le, MD, PhD, from The University of Texas MD Anderson Cancer Center, noted the trial's promising results in terms of response rate and duration, as well as the manageable safety profile of BAY 2927088.

The expansion phase aimed to assess the safety, tolerability, and pharmacokinetics of BAY 2927088 in patients with HER2-mutant NSCLC. This data supports the ongoing research into BAY 2927088 for advanced NSCLC with HER2 mutations. Bayer recently enrolled its first patient in the global Phase III SOHO-02 trial, which will evaluate the efficacy and safety of BAY 2927088 as a first-line therapy for advanced NSCLC with HER2 mutations.

Detailed results from the SOHO-01 study revealed that patients with advanced NSCLC harboring a HER2-activating mutation, who had progressed after at least one systemic therapy for advanced disease and were naïve to HER2-targeted therapy, were administered oral BAY 2927088 at a dose of 20 mg twice daily. Out of the 44 patients enrolled, 43 were evaluable for efficacy. The study reported a confirmed objective response rate (ORR) of 72.1%, with one complete response. The median duration of response (DOR) was 8.7 months, and progression-free survival (PFS) was 7.5 months. Patients with HER2 YVMA insertions, the most common mutation, showed an ORR of 90%, with a DOR of 9.7 months and a PFS of 9.9 months.

The safety profile of BAY 2927088 was manageable and consistent with previous reports. Treatment-related adverse events (TRAEs) were observed in 95.5% of patients, with 40.9% experiencing grade 3 TRAEs. The most common TRAE was diarrhea, followed by rash and paronychia. Three patients discontinued treatment due to TRAEs.

BAY 2927088 is an investigational agent and has not yet been approved for use by any health authority. It is being developed as a potential targeted treatment for NSCLC patients with HER2 activating mutations. The agent is an oral, reversible tyrosine kinase inhibitor (TKI) that selectively inhibits mutant forms of HER2 and epidermal growth factor receptors (EGFR).

Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC accounting for over 85% of cases. Activating HER2 mutations are present in 2% to 4% of advanced NSCLC cases. With the majority of NSCLC patients diagnosed at advanced stages, there is a critical need for more effective treatments.

Bayer is dedicated to advancing innovative treatments in oncology. The company's oncology portfolio includes several marketed products and multiple compounds in clinical development. Bayer focuses on precision oncology treatments, aiming to extend survival while minimizing side effects.

Bayer is a global enterprise with core competencies in healthcare and nutrition. The company is committed to driving sustainable development and innovation, employing around 100,000 people and generating significant revenue in the 2023 fiscal year.

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