The global phase III SOHO-02 trial, is initiated, being an open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of BAY 2927088 as first-line therapy in patients with advanced NSCLC with HER-2 mutations
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 (NSCLC), whose tumors have activating HER2 mutations
Beyond the SOHO-02 trial, investigational agent BAY 2927088 is also being assessed for its potential as a second-line therapy in adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. Late-breaking results from the phase I/II SOHO-01 trial will be presented in the presidential symposium at the World Conference on Lung Cancer (WCLC) in San Diego on Monday, September 9th, 2024.
“Our commitment to precision medicine is not just a promise but a mission to address the critical unmet needs of individuals battling HER2-mutant NSCLC, a variant of the most prevalent form of lung cancer,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “By advancing innovative research, we are dedicated to improving survival rates for those affected by this devastating disease. This endeavor underscores our commitment to pioneering precise and personalized healthcare solutions for those in direct need.”
Investigational agent BAY 2927088 is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA. Lung cancer is the leading cause of cancer-related deaths worldwide. Currently there are no approved targeted first-line therapies for patients with NSCLC harboring HER2 activating mutations. BAY 2927088 has received Breakthrough Therapy designation in the second-line setting from the FDA in February 2024. In June 2024, the Center for Drug Evaluation (CDE) in China also granted investigational agent BAY 2927088 Breakthrough Therapy designation for the same patient population.
About the SOHO-02 Study SOHO-02 is a global Phase III, open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy for adult patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations. Participants will be randomized to either investigational agent BAY 2927088 or the current standard of care (cisplatin/carboplatin + pemetrexed + pembrolizumab). The primary endpoint of the study is progression free survival (PFS) measured by a blinded, independent, central review. Additional endpoints include overall response rate (ORR), duration of response (DoR) and evaluating the safety of investigational agent BAY 2927088.
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