Akeso Reports Ivonescimab OS Benefit in HARMONi-2

Hong Kong, September 3, 2026

Akeso HARMONi-2 Study Demonstrates OS Benefit

The latest findings build on the earlier progression-free survival (PFS) success reported from HARMONi-2. In May 2024, a prespecified interim analysis conducted by the IDMC showed that ivonescimab met the study’s primary PFS endpoint, with a median PFS of 11.14 months compared with 5.82 months for pembrolizumab. The company described HARMONi-2 as the first randomized, double-blind Phase III trial to demonstrate a statistically significant positive result against pembrolizumab in this treatment setting. The newly reported OS result adds a key survival endpoint to the evidence generated by the head-to-head study. The trial is evaluating patients with locally advanced or metastatic NSCLC whose tumors are PD-L1 positive, making the results particularly relevant to first-line immuno-oncology treatment strategies. Unlike studies comparing experimental therapies with chemotherapy-based controls, HARMONi-2 directly evaluates ivonescimab against pembrolizumab, an established PD-1-targeting therapy. The achievement of positive PFS and OS results in this head-to-head setting could provide important clinical evidence for evaluating alternative approaches to first-line treatment of PD-L1-positive NSCLC. Akeso stated that the complete interim OS dataset will be disclosed through a future scientific presentation and peer-reviewed publication.

Ivonescimab Combines PD-1 and VEGF Targeting

Ivonescimab is Akeso’s investigational and now commercially developed PD-1/VEGF bispecific antibody, designed to combine immune checkpoint blockade with anti-angiogenic activity in a single molecule. The approach targets the PD-1 pathway, which can reactivate antitumor immune responses, while simultaneously targeting VEGF, a signaling pathway involved in tumor blood-vessel formation and the tumor microenvironment. Akeso describes ivonescimab as a first-in-class bispecific antibody based on its proprietary antibody technology platforms. The company has developed the molecule across multiple cancer indications and Phase III programs. The clinical development program has also generated evidence beyond HARMONi-2. Akeso previously reported positive Phase III results for ivonescimab-based treatment in EGFR-TKI-resistant nonsquamous NSCLC, while other Phase III programs are evaluating the therapy in additional lung and solid-tumor settings. In August 2026, the company also announced positive overall survival results from HARMONi-GI1, evaluating ivonescimab plus chemotherapy against durvalumab plus chemotherapy in first-line advanced biliary tract cancer. These developments illustrate the company’s broader strategy of expanding ivonescimab across multiple tumor types.

Akeso Expands Phase III Ivonescimab Development

The positive HARMONi-2 OS interim analysis represents another important milestone for Akeso’s clinical development program in lung cancer. The company said ivonescimab has now generated positive OS and PFS outcomes across multiple Phase III head-to-head trials involving PD-1/PD-L1 therapies. An international multicenter Phase III study, HARMONi-7, is also evaluating ivonescimab monotherapy versus pembrolizumab as first-line treatment for patients with high PD-L1 expression. Akeso is a biopharmaceutical company focused on developing innovative biological medicines across oncology, autoimmune disease, inflammation, metabolic disorders and central nervous system diseases. Its development infrastructure includes proprietary antibody technologies, an AI-powered drug R&D platform, ADC and T-cell engager technologies, and GMP manufacturing capabilities. With HARMONi-2 now demonstrating statistically significant OS benefit in its prespecified interim analysis, the company is positioned to further evaluate ivonescimab’s potential role in reshaping first-line PD-L1-positive NSCLC treatment.

Source: Akeso press release