Akeso Biopharma has concluded subject enrolment in the Phase III clinical trial of its antibody, Ivonescimab (AK112), plus chemotherapy to treat epidermal growth factor receptor (EGFR)-mutant, locally advanced or metastatic, non-squamous non-small cell lung cancer (nsq-NSCLC).
The company commenced subject enrolment at the end of January this year.
This double-blind, randomised, multicentre trial enrolled a total of 320 nsq-NSCLC patients who have failed treatment with an EGFR tyrosine kinase inhibitor (EGFR-TKI).
Progression-free survival (PFS) as evaluated by IRRC is the primary endpoint of the trial.
A PD-1/VEGF bi-specific antibody, Ivonescimab is developed by Akeso using Tetrabody technology.
It hinders the PD-1 attachment to PD-L1 and PD-L2 and also prevents VEGF binding to VEGF receptors.
In October this year, the therapy received Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China, National Medical Products Administration (NMPA) to treat advanced NSCLC.
Ivonescimab previously received a similar designation for the first-line treatment of patients with NSCLC and positive PD-L1 expression.
The company is currently carrying out a Phase III trial of AK112 single agent compared with Pembrolizumab monotherapy as the first-line therapy for such patients.
The therapy was earlier analysed in various trials for several stages of treatment of indications, including SCLC and NSCLC.
In October this year, the NMPA granted clearance for a Phase Ib/II trial of Ivonescimab plus Drebuxelimab (CD73, AK119) to treat advanced solid tumour patients.
In pre-clinical research, AK119 plus AK112 showed to have favourable in vivo pharmacodynamic activity and safety.
A humanised monoclonal antibody of the company, Drebuxelimab could activate B-cells to induce immune responses against tumour antigens and viruses.