CHICAGO, Illinois, May 31, 2026
Akeso, Inc. has announced landmark results from the pivotal Phase III HARMONi-6 trial, demonstrating that ivonescimab plus chemotherapy significantly improved overall survival (OS) compared with PD-1 inhibitor therapy plus chemotherapy in patients with first-line advanced squamous non-small cell lung cancer (sq-NSCLC). The breakthrough findings, presented during the prestigious ASCO 2026 Plenary Session and simultaneously published in The Lancet, mark a historic milestone as the first China-originated investigational oncology therapy selected for an ASCO plenary presentation. The study reinforces the growing potential of next-generation immuno-oncology therapies and positions ivonescimab as a strong contender to redefine the standard of care in advanced lung cancer treatment.
Phase III HARMONi-6 Delivers Significant Survival Advantage
The HARMONi-6 trial enrolled 532 patients with advanced squamous NSCLC, including a substantial proportion of individuals with difficult-to-treat disease characteristics such as low PD-L1 expression, multiple metastatic sites, liver metastases, and brain metastases. At the pre-specified interim analysis, ivonescimab combined with chemotherapy achieved a statistically significant and clinically meaningful improvement in overall survival compared with the control arm receiving tislelizumab plus chemotherapy.
The data demonstrated a remarkable 34% reduction in the risk of death for patients treated with ivonescimab, achieving a hazard ratio of 0.66. Median overall survival reached 27.9 months in the ivonescimab group compared with 23.7 months in the control arm. The survival benefit became increasingly pronounced over time, with the 24-month overall survival rate reaching 64.7% versus 48.6% in the comparator group. These findings represent one of the most compelling overall survival outcomes reported in first-line squamous NSCLC and underscore the potential of dual-targeted immunotherapy strategies to deliver long-term clinical benefits.
Consistent Clinical Benefits Across Key Patient Groups
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One of the most notable aspects of the HARMONi-6 study was the consistency of benefit observed across virtually all predefined patient subgroups. The survival advantage was maintained regardless of PD-L1 expression levels, demonstrating efficacy in both PD-L1-positive and PD-L1-negative populations. Patients with extensive metastatic disease, including those with three or more metastatic sites and liver metastases, also experienced meaningful improvements in survival outcomes.
In addition to overall survival, ivonescimab had previously achieved a significant improvement in progression-free survival (PFS), reducing the risk of disease progression by 40%. Median PFS reached 11.1 months compared with 6.9 months in the control group. This dual success in both overall survival and progression-free survival represents a major achievement in lung cancer research and highlights the differentiated mechanism of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody designed to simultaneously target immune suppression and tumor angiogenesis. Researchers noted that no prior therapy had successfully challenged the dominance of PD-1-based regimens in a head-to-head Phase III study of this magnitude.
Next-Generation Immunotherapy Poised to Transform Lung Cancer Care
Ivonescimab’s success extends beyond a single clinical trial and reflects the growing evolution of cancer immunotherapy toward more sophisticated and effective treatment approaches. By combining blockade of both PD-1 and VEGF pathways within a single molecule, the therapy has demonstrated the ability to enhance anti-tumor immune responses while disrupting the tumor microenvironment. Safety outcomes remained manageable and generally comparable to standard immunotherapy-based treatment regimens, supporting its potential for broader clinical adoption.
Akeso noted that ivonescimab is currently being evaluated in more than 30 clinical settings across multiple tumor types, including 15 Phase III studies globally. The positive HARMONi-6 results significantly strengthen the therapy’s clinical profile and provide further evidence that next-generation bispecific antibodies may play a central role in the future of oncology treatment. As lung cancer remains the leading cause of cancer-related mortality worldwide, the impressive survival gains reported in HARMONi-6 could influence future treatment guidelines and establish a new benchmark for first-line therapy in advanced squamous NSCLC.
Source: Akeso press release
