Bayer initiates the global phase III SOHO-02 trial for BAY 2927088, aiming to establish a new first-line therapy for advanced NSCLC with HER2 mutations. (Wikimedia commons) 
Medicine

Bayer Begins Patient Enrollment for Phase III SOHO-02 Trial in Non-Small Cell Lung Cancer

Bayer advances its oncology pipeline with the initiation of patient enrollment in the Phase III SOHO-02 trial, testing BAY 2927088 in non-small cell lung cancer

Ankur Deka

Bayer has announced the enrollment of the first patient in the global phase III SOHO-02 trial, a randomized, multicenter study investigating BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with HER2 mutations. This open-label trial aims to evaluate the safety and efficacy of BAY 2927088, an investigational agent derived from Bayer’s partnership with the Broad Institute of MIT and Harvard.

In addition to the SOHO-02 trial, BAY 2927088 is also being assessed as a second-line therapy for adult patients with unresectable or metastatic NSCLC who have previously undergone systemic treatment and have HER2 mutations. Results from the earlier phase I/II SOHO-01 trial will be presented at the World Conference on Lung Cancer (WCLC) in San Diego on September 9, 2024.

Bayer’s BAY 2927088 receives Breakthrough Therapy designation from the U.S. FDA and China’s CDE, marking a significant step in treating HER2-mutant lung cancer. (Wikimedia commons)

Christian Rommel, Ph.D., head of research and development at Bayer’s Pharmaceuticals Division, highlighted the company’s dedication to precision medicine and addressing the needs of those with HER2-mutant NSCLC. Bayer’s ongoing research is focused on improving survival rates and offering personalized treatment options for this challenging disease.

Lung cancer, the leading cause of cancer-related deaths globally, currently lacks approved targeted first-line therapies for patients with HER2-activated mutations. BAY 2927088, a reversible tyrosine kinase inhibitor, has received Breakthrough Therapy designation from both the U.S. FDA and China’s CDE, underscoring its potential as a significant new treatment option.

The SOHO-02 trial will compare BAY 2927088 to the current standard of care, involving cisplatin or carboplatin, pemetrexed, and pembrolizumab. The study’s primary endpoint is progression-free survival (PFS), with additional endpoints including overall response rate (ORR), duration of response (DoR), and safety.

Bayer is committed to advancing innovative treatments to enhance and extend the lives of cancer patients, reflecting its dedication to scientific progress and personalized healthcare solutions.

(Input from various sources)

(Rehash/Ankur Deka/MSM)

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