The Center for Drug Evaluation (CDE) website indicates that China-based Akeso Biopharma (HKG: 9926) has obtained two additional Breakthrough Therapy Designations (BTDs) for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). These designations follow last month’s BTD for AK112 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.
Latest BTD Indications
The latest two BTD indications are for first-line treatment of locally advanced or metastatic NSCLC with PD-L1 expression and for use in combination with docetaxel in locally advanced or metastatic NSCLC following previous failed treatment with a PD-1/L1 inhibitor. These designations highlight the potential of AK112 to address significant unmet needs in the treatment of advanced lung cancer.
AK112 Profile and Clinical Trials
AK112 is a self-developed bispecific antibody and is the world’s first PD-1/VEGF BsAb to enter Phase III trials. The drug is designed to block the PD-1 and VEGF pathways simultaneously, aiming to produce synergistic anti-tumor effects. Currently, a Phase III head-to-head study is underway for AK112 in first-line PD-L1 positive NSCLC compared with pembrolizumab. Another Phase III study is evaluating AK112 in combination with chemotherapy versus chemotherapy alone in advanced NSCLC with EGFR mutations resistant to EGFR-TKI treatment.-Fineline Info & Tech
