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

Bayer announced that the first patient has been enrolled in the global Phase II panSOHO study, an open-label clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 in adult patients with metastatic or unresectable solid tumors harboring HER2-activating mutations. These include tumors of the colon or rectum, the uterus and the cervix, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors, excluding advanced non-small cell lung cancer (NSCLC).

“This study is a critical step in evaluating a potential new treatment strategy for patients with a variety of solid tumors driven by HER2-activating mutations, who often have limited treatment options,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. 

Beyond the panSOHO trial, BAY 2927088 is also being investigated in patients with advanced NSCLC harboring HER2-activating mutations. The ongoing Phase III SOHO-02 trial (NCT 06452277) is evaluating BAY 2927088 as a first-line treatment option for these patients. Additionally, BAY 2927088 is being studied in the Phase I/II SOHO-01 trial for patients with advanced NSCLC and HER2-activating mutations who have received prior systemic therapy. In second-line NSCLC for patient with HER2-activating mutations, BAY 2927088 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.

HER2-activating mutations can drive the growth of several types of solid tumors, and patients with these mutations often have limited treatment options. The panSOHO study, designed as a basket trial, aims to investigate whether targeting these mutations with BAY 2927088 can offer benefit to these patients. In oncology, basket trials provide the opportunity to test a new drug or treatment on patients with different cancer types that share a common genetic characteristic, like HER2-activating mutation, with the goal of identifying effective, personalized treatments.

Investigational agent BAY 2927088 is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

www.bayer.com