Bayer Begins Phase III NSCLC Trial

Bayer has commenced patient enrollment for the global Phase III SOHO-02 trial, a significant step in evaluating the efficacy and safety of BAY 2927088. This investigational agent is being tested as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with activating HER2 mutations. The trial is open-label, randomized, and involves multiple centers worldwide. 

In addition to the SOHO-02 trial, BAY 2927088 is under investigation for its potential use as a second-line therapy in adult patients with unresectable or metastatic NSCLC, who have HER2 mutations and have undergone prior systemic therapy. The latest findings from the Phase I/II SOHO-01 trial will be showcased at the World Conference on Lung Cancer (WCLC) in San Diego on September 9, 2024.

Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division, emphasized the company's dedication to precision medicine. He highlighted Bayer's mission to improve survival rates for individuals with HER2-mutant NSCLC through advanced research and personalized healthcare solutions.

BAY 2927088 emerged from Bayer’s strategic collaboration with the Broad Institute of MIT and Harvard, located in Cambridge, MA, USA. Lung cancer remains the leading cause of cancer-related deaths globally, and there are currently no approved targeted first-line therapies for NSCLC patients with HER2 activating mutations.

In February 2024, the U.S. Food and Drug Administration (FDA) designated BAY 2927088 as a Breakthrough Therapy for second-line treatment. Similarly, China’s Center for Drug Evaluation (CDE) granted it Breakthrough Therapy designation in June 2024 for the same patient group.

The SOHO-02 study is a pivotal Phase III trial that will randomize participants to either BAY 2927088 or the current standard of care, which includes a combination of cisplatin or carboplatin, pemetrexed, and pembrolizumab. The primary endpoint of the trial is progression-free survival (PFS), assessed by an independent, central review. Other key endpoints include the overall response rate (ORR), duration of response (DoR), and the safety profile of BAY 2927088.

BAY 2927088 is an investigational oral, reversible tyrosine kinase inhibitor (TKI) that targets mutant HER2 and EGFR with high selectivity over wild-type EGFR. It has not yet been approved by any health authority for any indication and is being studied as a potential new treatment option for NSCLC patients with HER2 activating mutations.

Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancer cases, with HER2 mutations present in 2% to 4% of these advanced cases. Most individuals diagnosed with NSCLC are already in advanced stages, complicating treatment efforts.

Bayer is committed to advancing oncology treatments through a diverse portfolio of innovative therapies. The company’s oncology division is focused on developing new medicines to improve and extend the lives of cancer patients. This includes marketed products across various indications and compounds in different stages of clinical development, particularly in Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology.

Bayer’s dedication to precision oncology is evident in their development of a TRK inhibitor for tumors with NTRK gene fusions. The global enterprise aims to drive forward healthcare and nutrition initiatives through sustainable development and innovation. In 2023, Bayer employed about 100,000 people and reported sales of 47.6 billion euros, with significant investment in research and development.

Bayer’s brand represents trust, reliability, and quality worldwide, committed to addressing the major challenges posed by a growing and aging global population. The company strives to enhance health and nutrition outcomes, supporting both people and the planet.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!