Akeso, Inc. announced that a pre-specified interim analysis of overall survival (OS) in the HARMONi-2 (AK112-303) trial, as assessed by the Independent Data Monitoring Committee (IDMC), met the key secondary endpoint of OS. The results demonstrated that ivonescimab showed statistically significant and clinically meaningful improvement over pembrolizumab.

HARMONi-2 is a randomized, double-blind, multicenter, registrational Phase III trial evaluating ivonescimab, Akeso's first-in-class PD-1/VEGF bispecific antibody, versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (TPS ≥1%).

Detailed data from the interim OS analysis will be presented at an upcoming international medical conference and published in a peer-reviewed journal.

In May 2024, at a prespecified interim analysis conducted by the IDMC, ivonescimab met its primary endpoint of progression-free survival (PFS) in the HARMONi-2 study, with a median PFS of 11.14 months versus 5.82 months for pembrolizumab. HARMONi-2 is the first randomized, double-blind Phase III trial to show a significant positive outcome against pembrolizumab in this setting.

In 2025, this indication received regulatory approval in China. The approval removed previous restrictions on the use of VEGF-targeted agents in patients with squamous histology and provided a chemotherapy-free treatment option that has been well received in clinical practice.

Dr. Yu Xia, Founder, Chairwoman, President and Chief Executive Officer of Akeso: 

"We are pleased that the fourth Phase III study of an ivonescimab-based regimen has now demonstrated statistically significant benefit in both overall survival and progression-free survival. These results further reinforce the clinical value of ivonescimab in the treatment of lung cancer. 

We thank the investigators, clinical teams and patients who participated in the HARMONi-2 study for their important contributions. 

To date, ivonescimab has achieved dual positive OS and PFS outcomes across multiple Phase III head-to-head trials versus PD-1/PD-L1 therapies. This growing body of evidence strengthens our confidence in its potential across a broader range of solid tumors. With its unique dual mechanism of action combining immunotherapy and anti-angiogenesis, we believe ivonescimab offers a more effective treatment option for patients and will contribute meaningfully to the evolving oncology treatment landscape."