Enrollment Begins in Phase 3 SOHO-02 Trial of BAY 2927088 in NSCLC
The phase 3 SOHO-02 trial has enrolled its first patient with advanced non–small cell lung cancer harboring activating HER2 mutations.
Microscopic image of non-small cell lung cancer - Generated with Google Gemini AI.jpeg
The first patient with advanced non–small cell lung cancer (NSCLC) with a tumor that has activating HER2 mutations has been enrolled in the phase 3 SOHO-02 trial (NCT06452277) of frontline treatment with BAY 2927088.1
BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI). The agent potently inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations. Additionally, BAY 2927088 inhibits EGFR and has high selectivity for mutant vs wild-type EGFR.
The global, open-label, randomized, multicenter trial plans to evaluate the efficacy and safety of BAY 2927088, an investigational agent, as first-line therapy.
“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, PhD, head of research and development at Bayer’s pharmaceuticals division, in a press release. “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.”
In SOHO-02, adult patients with advanced NSCLC whose tumors have activating HER2 mutations will be enrolled and randomly assigned to receive either treatment with BAY 2927088 or the current standard of care, which consists of cisplatin/carboplatin plus pemetrexed and pembrolizumab (Keytruda).2
BAY 2927088 20 mg will be given to patients twice daily as a tablet by mouth. Patients will continue to receive treatment for as long as they benefit from it without any severe adverse effects, until disease progression, or until they or their doctor decides to stop the treatment.
Progression-free survival measured by a blinded, independent, central review is the primary end point of the study. Secondary end points being explored include overall response rate, duration of response, overall survival, disease control rate, and safety.
In addition to the SOHO-02 trial, BAY 2927088 is being evaluated as a second-line treatment for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy in the phase 1/2 SOHO-01 trial (NCT05099172).1 Data from this study will be presented in the presidential symposium at the World Conference on Lung Cancer on September 9th, 2024.
REFERENCES:
1. Bayer starts phase III trial in non-small cell lung cancer (NSCLC). News release. Bayer. August 29, 2024. Accessed August 29, 2024. https://tinyurl.com/5fzf22ry
2. A study to learn more about how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced non-small cell lung cancer (NSCLC) with mutations in the genes of human epidermal growth factor receptor 2 (HER2) (SOHO-02). ClinicalTrials.gov. Updated August 19, 2024. Accessed August 29, 2024. https://clinicaltrials.gov/study/NCT06452277
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