Akeso, Inc. (HKG:9926), a China-based pharmaceutical company, announced on Wednesday that the first patient has been dosed in its pivotal Phase III clinical study (AK112-305/HARMONi-8A) of ivonescimab (PD-1/VEGF bispecific antibody) in combination with docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed following PD-1/L1 inhibitors and platinum-based chemotherapy.

Ivonescimab is currently the only bispecific immunotherapy antibody in Phase III registration trials specifically for IO-resistant NSCLC. There are no approved standard treatments for this population, and the efficacy of docetaxel monotherapy remains limited despite its guideline-recommended use.

Mechanistic studies suggest that PD-1 therapy can restore the immune system's anti-tumour activity, while anti-VEGF therapy alleviates VEGF-mediated immune suppression and promotes T-cell infiltration. When combined, these two therapies may produce synergistic effects. Ivonescimab simultaneously targets both PD-1 and VEGF pathways, reversing the immune-suppressive tumour microenvironment and reactivating anti-tumour immune responses.

Supported by positive efficacy and safety outcomes in a Phase II study, the Phase III trial is a key component of Akeso's "Immuno-2.0" strategy. The company anticipates the study will establish a novel, effective option for IO-resistant NSCLC and expand ivonescimab's role across multiple lines of treatment.