Biotechnology companies Akeso and Summit Therapeutics reported that their new drug, ivonescimab, significantly extends the lives of patients with non-small cell lung cancer (NSCLC). In a Phase 3 clinical trial, the drug outperformed pembrolizumab, a widely used treatment that had remained the gold standard for nearly 10 years. The Clinical Trial Vanguard reports.
The HARMONi-2 study, a randomized Phase 3 clinical trial of the drug, showed that the new therapy simultaneously blocks PD-1, a protein that helps tumors evade the immune system, and VEGF, a protein that promotes the growth of blood vessels that supply tumors. Previously, scientists had been concerned about using such blocking combinations because of the risk of fatal bleeding in patients with squamous cell carcinoma. However, the innovative molecule proved to be sufficiently safe that China has already lifted these restrictions, expanding the pool of potential patients for further trials.
The drug had already demonstrated a significant advantage in delaying disease progression: 11.14 months compared with 5.82 months with the comparator. Now, it has also demonstrated an advantage in overall survival, a measure that can directly influence clinical treatment guidelines. Exact figures have not yet been disclosed, and researchers plan to present them at an upcoming international conference.
Pembrolizumab had remained the standard first-line treatment for NSCLC for nearly a decade in patients whose tumors express the relevant biomarker. The earlier drug targeted only PD-1 on the surface of immune cells (T lymphocytes), effectively releasing an immune “brake” and allowing the body to recognize and destroy cancer cells.
In 2022, U.S. company Summit Therapeutics acquired the rights to develop and commercialize ivonescimab in the United States and Europe for $500 million. The U.S. Food and Drug Administration (FDA) is currently reviewing the application for approval of the new drug, with a final decision expected as early as November.
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