Kangfang Biopharma's first global multicenter Phase III clinical study results announced: the primary endpoint has been achieved
On September 7, updated data from the first global, multicenter Phase III clinical study (HARMONi) of Kangfang Biopharma's ivorizumab (AK112) were presented at the World Lung Cancer Conference. The study evaluated the efficacy and safety of ivorizumab combined with chemotherapy in patients whose disease progressed after third-generation EGFR-TKI therapy. Results showed a significant improvement in overall survival (OS) with a median follow-up of 13.7 months, with a significant survival benefit in North American patients. Ivoirizumab is the world's first dual-antibody PD-1/VEGF inhibitor. Last year, in a registrational Phase III trial (HARMONi-2) in China as a single-agent first-line treatment for PD-L1-positive non-small cell lung cancer, ivorizumab demonstrated longer progression-free survival (PFS) than Merck & Co.'s PD-1 inhibitor, pembrolizumab (commonly known as "K drug"), demonstrating its potential to replace pembrolizumab. Ivoirizumab shot to fame, becoming the world's most popular dual-antibody.