Chinese pharmaceutical company Akeso Inc (HK:9926) announced on Thursday that the results from the registrational Phase III AK112-306/HARMONi-6 study of ivonescimab have been accepted for publication in The Lancet.

The study evaluated ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, combined with chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). The Lancet article will be simultaneously published during the 2025 European Society for Medical Oncology (2025 ESMO) Congress.

Results from the HARMONi-6 trial were also selected as a Late-Breaking Abstract for the 2025 ESMO Congress. Professor Lu Shun, director of the Oncology Department at Shanghai Chest Hospital, presented the study's findings at the Presidential Symposium.

According to Akeso, HARMONi-6 marks a significant advancement for ivonescimab following its success in the head-to-head study against pembrolizumab as first-line treatment for PD-L1-positive NSCLC. The Phase III study has now demonstrated positive outcomes in a comparison of ivonescimab plus chemotherapy versus PD-1 inhibitor plus chemotherapy for the first-line treatment of squamous NSCLC, addressing a key unmet need in the treatment for advanced squamous NSCLC using anti-angiogenic agents. These successful outcomes demonstrate that ivonescimab achieves significant clinical breakthroughs, not only in comparison to PD-1 monotherapy or PD-1 combination chemotherapy, the current standard of care for many cancers in the immuno-oncology field, but also against VEGF-targeted therapies in anti-angiogenesis, Akeso said.

The encouraging results from the HARMONi-6 study have led to the review of a supplemental New Drug Application (sNDA) in China for ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous NSCLC.