China-based Akeso Biopharma (HKG: 9926) has announced the completion of enrollment for its Phase III study of AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). The study aims to assess the drug in combination with chemotherapy for locally advanced or metastatic non-squamous non-small cell lung cancer (nsq NSCLC) with epidermal growth factor receptor (EGFR) mutations resistant to previous EGFR tyrosine kinase inhibitor (TKI) treatment.
Study Design and Objectives
The randomized, double-blind, multi-center Phase III study has enrolled 320 subjects. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiological Review Committee (IRRC). AK112 is designed to block the PD-1 and VEGF pathways simultaneously, aiming to produce synergistic anti-tumor effects.
Ongoing Clinical Trials
In addition to the completed enrollment for this Phase III study, Akeso is also conducting a Phase III head-to-head study for AK112 in first-line programmed-death ligand 1 (PD-L1) positive NSCLC compared with pembrolizumab. Another Phase III study is underway to evaluate the drug combined with chemotherapy against chemotherapy alone in advanced NSCLC with EGFR mutations resistant to EGFR-TKI treatment.
Future Development
These ongoing trials highlight Akeso Biopharma’s commitment to advancing innovative therapies for patients with advanced lung cancer. The completion of enrollment for the Phase III study of AK112 is a significant milestone in the company’s clinical development program.-Fineline Info & Tech
