Bayer begins Phase II trial of BAY 2927088 for HER2 mutant solid tumors

Bayer has announced the enrollment of the first patient in its global Phase II panSOHO trial. This study is an open-label clinical trial designed to assess the efficacy and safety of the investigational drug BAY 2927088 in adults with metastatic or inoperable solid tumors that present HER2-activating mutations. This study includes various tumor types such as those found in the colon, rectum, uterus, cervix, bladder, and biliary tract, but excludes advanced non-small cell lung cancer (NSCLC).

Dr. Christian Rommel, leading Bayer’s Pharmaceuticals Division’s Research and Development, expressed enthusiasm about the initiation of the panSOHO trial. He highlighted the study as an important effort in Bayer's commitment to precision oncology, aiming to discover targeted therapies for cancer patients who face limited treatment options due to HER2-activating mutations.

In addition to the panSOHO trial, BAY 2927088 is under investigation for its potential in treating NSCLC patients with HER2-activating mutations. The Phase III SOHO-02 trial is evaluating its effectiveness as an initial treatment option. Furthermore, the SOHO-01 Phase I/II trial is testing the drug on NSCLC patients who have already undergone systemic therapy. The drug has also been granted Breakthrough Therapy Designation by the U.S. FDA and China’s NMPA for its use in second-line NSCLC treatment with HER2 mutations.

HER2-activating mutations are known to drive the growth of various solid tumors, often leaving patients with minimal treatment alternatives. The panSOHO study seeks to evaluate if targeting these mutations with BAY 2927088 can provide therapeutic benefits. The study uses a basket trial design, which allows the testing of a new drug across different types of cancer that share a genetic trait, in this case, HER2-activating mutations, with the aim of developing personalized treatments.

BAY 2927088 results from Bayer’s research collaboration with the Broad Institute of MIT and Harvard in the USA. The panSOHO study, a global Phase II basket trial, focuses on measuring the objective response rate as its primary endpoint, assessed through an independent central review. Secondary endpoints include duration of response, progression-free survival, and the drug’s safety profile.

BAY 2927088 is still under investigation and has not received approval from any regulatory body. It is being explored as a novel targeted treatment for advanced NSCLC patients with HER2 mutations. As an oral, reversible tyrosine kinase inhibitor, BAY 2927088 selectively inhibits mutant HER2 and EGFR receptors, focusing on mutant forms over wild-type EGFR.

Bayer is dedicated to improving cancer treatment through innovative therapies. The company’s oncology portfolio includes several marketed products and ongoing clinical trials, emphasizing tumor cell pathways, targeted radionuclide therapies, and next-generation immuno-oncology. Bayer is also advancing prostate cancer treatments, aiming to extend survival with minimal side effects. Part of their precision oncology efforts includes a TRK inhibitor for tumors with NTRK gene fusions.

Bayer is a global enterprise working in health care and nutrition, committed to sustainable development and innovation. Employing around 100,000 people, Bayer reported substantial sales and R&D investments in 2023, reinforcing its brand's values of trust and quality worldwide.