China-based Akeso Biopharma has presented practice-changing Phase III data from the HARMONi‑6 study for its first-in-class PD‑1/VEGF bispecific antibody (BsAb), ivonescimab. In a head‑to‑head trial against the standard of care (tislelizumab + chemotherapy) for first‑line advanced squamous non‑small cell lung cancer (NSCLC), the AK112 combination demonstrated a statistically significant overall survival (OS) benefit. With a median follow‑up of 21.4 months, it reduced the risk of death by 34% (HR=0.66) and extended median OS to 27.9 months versus 23.7 months in the control arm.

The survival benefit was consistent across all key subgroups, including patients with low or negative PD‑L1 expression and those with baseline liver metastases. This builds on a previously reported 40% reduction in progression risk (PFS HR=0.60). The safety profile was manageable and comparable to the PD‑1 + chemotherapy control, with no new signals detected despite the dual mechanism of action. This dataset positions AK112 as a potential new global standard in this difficult‑to‑treat population.

PharmCube's NextBiopharm® database shows that ivonescimab has succeeded in all previous squamous NSCLC trials. Click here to request a free trial for NextBiopharm®.