Akeso Inc. reported that its first-in-class PD-1/VEGF bispecific antibody, ivonescimab, achieved a statistically significant and clinically meaningful overall-survival (OS) benefit over pembrolizumab in the interim analysis of the global Phase III HARMONI-2 study (AK112-303/NCT05499390). The Independent Data Monitoring Committee confirmed the trial met its pre-specified key secondary endpoint of OS in previously untreated patients with PD-L1-positive (TPS ≥ 1 %) locally advanced or metastatic non-small cell lung cancer (NSCLC).

The randomized, double-blind trial enrolled 398 participants. Primary results released in May 2024 showed ivonescimab met the primary endpoint of progression-free survival (PFS), delivering a median PFS of 11.14 months versus 5.82 months for pembrolizumab (hazard ratio 0.51; P < 0.0001). The new OS findings reinforce ivonescimab’s clinical value as an emerging immuno-oncology backbone therapy; detailed OS data will be presented at a forthcoming medical conference and submitted to a peer-reviewed journal.

Ivonescimab secured its first marketing approval in China on 24 May 2024 for EGFR-mutated, locally advanced or metastatic non-squamous NSCLC after EGFR-TKI failure. Subsequent supplemental approvals covered first-line PD-L1-positive NSCLC in April 2025 and first-line squamous NSCLC in August 2026, with both indications listed on the National Reimbursement Drug List. More than 60 Phase II/III trials across over 40 indications are underway, including 17 registrational studies.

The company emphasizes that ivonescimab’s bispecific design addresses historical anti-VEGF contraindications in squamous NSCLC and enables a chemotherapy-free regimen, broadening treatment options for lung-cancer patients.