China’s Akeso Bio has secured a breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) for its bispecific antibody (BsAb) AK112, targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in first-line, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression (TPS≥1%). The drug is designed to block both PD-1 and VEGF pathways to enhance anti-tumor efficacy.
Drug Profile and Mechanism
AK112 has demonstrated efficacy in renal cell carcinoma, NSCLC, hepatocellular carcinoma, and other cancers. The BTD follows positive data in NSCLC patients, positioning it as a potential first-line therapy. The drug’s dual-target mechanism aims to overcome resistance mechanisms in PD-1 monotherapy.
Clinical Development
- Ongoing Trials: A Phase III study in NSCLC patients who failed EGFR-TKI treatment is underway.
- Upcoming Trials: Phase III trials in driver gene-negative PD-L1+ NSCLC and first-line extensive small cell lung cancer (SCLC) are planned.
- Combination Study: A Phase Ib/II trial combining AK112 with cadonilimab (with/without chemotherapy) in advanced NSCLC has received approval.
Strategic Outlook
Akeso Bio aims to establish AK112 as a cornerstone therapy in lung cancer, leveraging its BTD to accelerate regulatory milestones. The company’s pipeline includes multiple BsAb candidates targeting immuno-oncology and autoimmune diseases.-Fineline Info & Tech
